Author Archives: admin


Hemophilia Treatment Market 2020 By End-User Demand, Emerging Trend, New Innovations, Future Prospect, Detailed Analysis and Forecast 2027 – MR…

Hemophilia Treatment Market In-Depth Analysis, Regional Outlook

Hemophilia is a condition where blood does not clot, and this condition is normally inherited. The condition is caused due to defects in a gene of the X chromosome, which is a clotting factor. Generally, the diseases are widely seen in males as the X chromosome is inherited from mother to baby boy. The disease is widely treated with replacement therapy and gene therapy. The other treatment which is used is medication. However, there are ways to reduce the risk of the condition, which include regular exercise and others. The condition can be prevented by taking preventive treatment by injection of clotting factor VIII for hemophilia A, or IX for hemophilia B.

The hemophilia treatment market was valued at US$ 14,454.81 million in 2019 and is expected to grow at a CAGR of 15.9% from 2020 to 2027 to reach US$ 44,089.71 million by 2027.

Request Sample Copy of Hemophilia Treatment Market at:https://www.theinsightpartners.com/sample/TIPRE00008241/

Some of the key players profiled in the study areBayer AG, Sanofi, F. Hoffmann-la Roche Ltd., Kedrion S.P.A., CSL Limited, Biotest AG, Pfizer Inc., Novo Nordisk A/S, Octapharma AG, Baxter International Inc., etc.

Hemophilia Treatment Market Trends, Growth, Future Scope

Based on end user, the hemophilia treatment market is segmented into hospitals & clinics, hemophilia treatment centers, and ambulatory surgical centers. The hospitals and clinics held the largest share of end user segment in the global market. Moreover, the same segment is expected to grow at the fastest rate during the coming years. The hospital is a complex organization or an institute that provides health to people through complicated but specialized scientific equipment. The team of trained staff in the hospital, educated in the problems of modern medical science. They are all coordinated together for the common goal of restoring and maintain good health. Medical research is constantly pushing the boundaries of health care and redefining what is and isnt possible. The hospitals offer advanced treatment options as a resource for patients for chronic and hard-to-heal wounds and surgeries to treat them. Most of the surgeries are being performed in hospitals, owing to continuous patient care and monitoring. Also, increasing government funding in the hospitals and rising hospital research drives the market growth.

The research provides answers to the following key questions:

The report profiles the key players in the industry, along with a detailed analysis of their individual positions against the global landscape. The study conducts SWOT analysis to evaluate strengths and weaknesses of the key players in the Hemophilia Treatment market. The researcher provides an extensive analysis of the Hemophilia Treatment market size, share, trends, overall earnings, gross revenue, and profit margin to accurately draw a forecast and provide expert insights to investors to keep them updated with the trends in the market.

Competitive scenario:

The study assesses factors such as segmentation, description, and applications of Hemophilia Treatment industries. It derives accurate insights to give a holistic view of the dynamic features of the business, including shares, profit generation, thereby directing focus on the critical aspects of the business.

Global Hemophilia Treatment Market By Product

Global Hemophilia Treatment Market By Disease

Global Hemophilia Treatment Market By Treatment Type

Global Hemophilia Treatment Market By Therapy

Global Hemophilia Treatment Market By End User

Global Hemophilia Treatment Market By Geography

Major highlights of the report:

All-inclusive evaluation of the parent market

Evolution of significant market aspects

Industry-wide investigation of market segments

Assessment of market value and volume in past, present, and forecast years

Evaluation of market share

Study of niche industrial sectors

Tactical approaches of market leaders

Lucrative strategies to help companies strengthen their position in the market

Interested in purchasing this Report? Click here @https://www.theinsightpartners.com/buy/TIPRE00008241/

Thanks for reading this article; you can also customize this report to get select chapters or region-wise coverage with regions such as Asia, North America, and Europe.

About Us:

The Insight Partnersis a one stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We are committed to provide highest quality research and consulting services to our customers. We help our clients understand the key market trends, identify opportunities, and make informed decisions with our market research offerings at an affordable cost.

We understand syndicated reports may not meet precise research requirements of all our clients. We offer our clients multiple ways to customize research as per their specific needs and budget

Contact Us:

The Insight Partners,

Phone: +1-646-491-9876

Email:[emailprotected]

See more here:
Hemophilia Treatment Market 2020 By End-User Demand, Emerging Trend, New Innovations, Future Prospect, Detailed Analysis and Forecast 2027 - MR...

Poignant photos reveal how sickness and healthcare touch so many facets of life – CNN

Written by Jacqui Palumbo, CNN

Healthcare doesn't just take place in hospitals, and in the time of a global pandemic, it is especially relevant to consider how it touches all aspects of our lives.

The Wellcome Photography Prize aims to do just that by celebrating visual stories that challenge mental health stigmas, highlight social inequalities in medicine, and show how individuals care for one another and themselves.

The 2020 prize, run by the Wellcome Trust health research charity, has revealed its shortlist from 25 professional and amateur photographers from 13 different countries, chosen from an open-call for submissions.

The striking portraits that speak to humanity now

Across a range of documentary and more conceptual images, topics explored by the shortlisted photographers include maternity care in rural areas, the impact of climate change on communities, and depression and anxiety.

Arseniy Neskhodimov's conceptual self-portrait series "Prozac" visualizes how he lives daily with depression. Credit: Arseniy Neskhodimov / Wellcome Photography Prize 2020

With two categories dedicated to mental health, this year's special focus showcases the importance of representing interior struggles and explores how we can better care for our minds. Winners of this year's prize will be announced on August 19, with cash prizes including an overall award for 15,000 (around $20,000).

Below is a selection of shortlisted images that show the prize's varied and powerful representations of healthcare.

Gianluca Urdiroz Agati/Wellcome Photography Prize 2020

Gianluca Urdiroz Agati took this portrait of Adrian holding his son Luca, who he has picked up from school. Adrian, who is originally from Romania, is blind and now living in Bournemouth, UK. Agati notes that touch is central to their relationship; for instance, when he is not in school Luca helps his father navigate the world.

Rebel girls create their own utopia in Justine Kurland's pictures

The portrait is part of a larger body of work by the UK-based, Italian-Spanish photographer, which focuses on father-son relationships and how they reflect contemporary ideas of masculinity. With this image Agati emphasizes that tenderness is a trait that is often overlooked in the portrayal of male relationships.

"While being embraced by his father Adrian, I find that Luca's confidence comes through and makes this image striking," Agati said over email. "The image evokes a contrast between strength and tenderness, of trust and protectiveness that reflects the very specific bond they have."

Going Under Lagos, Nigeria, 2019 A mother carries her children to school through a flooded street. Credit: Nyancho NwaNri/Wellcome Photography Prize 2020

Lagos-based photographer Nyancho NwaNri took this image in 2019 of a mother carrying her child to school in her home city, with floodwaters nearly knee-high. In neighborhoods along the Lagos Lagoon, annual flooding has been exacerbated by rising sea levels due to climate change.

"Apart from the physical damage and the risk of water-borne diseases, there comes a threat to mental health," NwaNri writes in Wellcome Prize's online gallery image caption. "Living through a natural disaster -- or one fuelled by human activity -- is traumatic. Floods, droughts and extreme weather can destroy your assumptions about the safety of your home. Climate change is a threat to mental health just as it is to physical health, and governments' responses to it must take that into account."

Marijn Fidder/Wellcome Photography Prize 2020

Since 2017, Dutch photographer Marijn Fidder has photographed the project "Naughty Cells," showing the honest day-to-day lives of children being treated for cancer. By creating photo albums for their families, she hopes to help them through the emotional journey.

This image from 2018 of Sanne, 11 years old, who has a brain tumor, shows the young girl in her bedroom, surrounded by greeting cards pinned to her walls that have been given to her by her loved ones. "She was showing me the gifts that she got and suddenly she stretched out on her bed and smiled," Fidder recalled over email.

"Sanne takes joy in the knowledge that she's not alone," the photo caption reads. "Cancer is always frightening, and it can be particularly confusing for children. A child may not understand what is happening to them, or why, or what might happen next."

Fidder recalled over email the first time she met Sanne, at the hospital during the child's first chemo treatment. "I was photographing a boy for my series. It was one of his last days of treatment, while it was the beginning of Sanne's story (with) cancer."

Sameer Satchu/Wellcome Photography Prize 2020

Tanzania-based photographer Sameer Satchu (who goes by Sam Vox), documented Ugandan midwife Agness in 2019 as she leaned in close to a patient to hear her fetus's heartbeat using a 19th-century Pinard horn. In rural Uganda, Vox notes, healthcare can be difficult to access and clinics often lack resources.

"The healthcare workers are tireless and dedicated to their communities," Vox's caption reads. "They could do more with better equipment, but if that isn't available, they will still find ways to improve what they can do and give the best possible care to their patients."

Vox believes his image of Agness challenges what he sees as a prevalent, negative view of Africa. "There's so much narrative that portrays Africa as this 'helpless continent,' he wrote over email. "(This photograph) resonates with me because this is how I see my people, as passionate and very hardworking."

Maite Carams/Wellcome Photography Prize 2020

Barcelona-based photographer Maite Carams was able to us her camera to help her friend Valrie when she was diagnosed with breast cancer in 2014. At Valrie's request, Carams took photos of her throughout chemotherapy to show her experience fighting the disease. "It meant to me a lot because (she regarded the series) as a form of therapy, and that makes feel very proud," Carams said over email.

Carams took this portrait of her friend post surgery. The view is of Valrie's back, and shows her chest wrapped in gauze, her wig by her side and her vibrant blue headscarf draped down her back.

Beauty of mastectomy tattoos revealed in powerful photo project

"When you go through this you have to find ways to maintain your courage, your mood, your dignity, and even your identity," Carams wrote in her caption. "In this grueling process, friendship is invaluable."

Ed Kashi/Wellcome Photography Prize 2020

In 2014, New York-based photojournalist Ed Kashi photographed Daisy, 38, and her mother Sonia, 58, just after they learned that Daisy is genetically predisposed to early onset Alzheimer's, a disease that Sonia had been struggling with for ten years. Daisy is Sonia's full-time caretaker. "I've looked into homes but I don't have the heart to do it," Daisy said in the image caption. "She's my world. Why would I turn my back on her now when she needs me the most?"

"Being allowed to witness this intimate moment between a mom and daughter was both emotional and humbling," Kashi said over email. "Daisy is a true hero in allowing (me) to record the moment she found out she has the gene, like her mom, that almost assures her of early onset of Alzheimer's. Her bravery in participating in this story is fueled by her desire to help others."

Tom Merilion/Wellcome Photography Prize 2020

London-based photographer and filmmaker Tom Merilion took this portrait of Nina with her eyes closed as she takes a rest during her daily swim routine in Scotland's River Spey -- which she keeps up as a balm for her anxiety and depression. A 2018 case study found that cold water swimming could have a positive effect on major depressive disorders.

"It makes all my senses feel alive no matter how dead inside I feel going in," Nina is quoted in the image caption. "I notice natural life, the seasons and the weather, the way the water is moving around me, and importantly it makes me feel like I am actually capable and can achieve amazing things."

See more here:
Poignant photos reveal how sickness and healthcare touch so many facets of life - CNN

Strathmore man with MS calls for more Canadian treatment alternatives – CTV Toronto

CALGARY -- Hes just 49 years old and already his mobility is mostly confined to his right hand. If Chad Tashlikowich can halt the progression of his primary-progressive multiple sclerosis (MS) there, hell consider it a victory.

In 2014 Tashlikowich crowd-funded an $80,000 stem cell treatment in Russia hoping to keep him out of an electric wheel chair. That therapy was unsuccessful.

It really hasnt changed the trajectory at all, he says. Despite the risks and expense, his health didnt improve. Its really poor. Its kind of gone downhill really ever since. I dont think the stem cells did a lot,

Now he wants to try a drug treatment ocrevus recommended to him by an American physician, Dr. Aaron Boster, who specializes in MS, a disease that attacks the central nervous system.

The problem is, in Canada the drug is not approved for use on patients with Tashlikowichs form of the disease.

You have a mechanic for your car. And if he doesnt do a good job you get another one. You cant do that with a neurologist, Tashlikowich says.

Dr. Luann Metz is a neurology professor at the University of Calgary. She says she understands how MS patients can see some of these therapies as worth the expense and the risk, given their dire prognoses. But Metz cautions that not all foreign treatment is what its advertised to be, and even when it is, there are medical reasons why guidelines are what they are in Canada.

The problem is, that when people go outside the country for unapproved therapies, they are often not in regulated situations, says Dr. Metz, adding that stem cell therapy in particular has shown to sometimes worsen outcomes in primary-progressive MS patients.

Link:
Strathmore man with MS calls for more Canadian treatment alternatives - CTV Toronto

Avacta extends partnership with Daewoong Pharmaceutical and AffyXell Therapeutics for Covid-19 stem cell treatments – Cambridge Independent

Avacta has extended its collaboration and license agreement with Daewoong Pharmaceutical Co and their South Korean joint venture AffyXell Therapeutics.

They will develop stem cell treatments incorporating Avactas neutralising Affimer therapy for the treatment of seriously ill patients with Covid-19 and prepare for the rapid development of similar therapies for future global pandemics.

Stem cell therapies offer one potential route to repairing lung tissue damage caused by the immune systems over-reaction to respiratory diseases such as Covid-19.

AffyXell Therapeutics, a next-generation cell and gene therapy joint venture between Whittlesford-based Avacta and Daewoong, is developing mesenchymal stem cell (MSC) treatments engineered to produce Affimer therapies in the patient at the site of action.

The partnership has been extended to include Affimer molecules that target viruses, such as coronaviruses, to develop therapies that repair lung damage, while also producing neutralising Affimer molecules to prevent the progression of the disease.

Under the expanded partnership, AffyXell will engineer mesenchymal stem cells to express SARS-CoV-2 neutralising Affimer molecules to develop treatments for seriously ill Covid-19 patients. It will also prepare for rapid development of next-generation stem cell therapies for future infectious respiratory disease outbreaks.

Avacta CEO Dr Alastair Smith said: I am very pleased to have extended our collaboration and license agreement with Daewoong Pharmaceutical to include the SARS-CoV-2 neutralising Affimer molecules for the treatment of Covid-19 and to create the potential to respond very rapidly in future to global virus threats.

AffyXell will address the need over the coming years for advanced stem cell therapies to treat lung damage caused by cytokine release syndrome suffered by Covid-19 patients and, at the same time, help prevent disease progression in these patients through the action of a neutralising Affimer therapy.

More broadly, one of the key areas of unmet clinical need that AffyXell can address with its next-generation mesenchymal stem cell therapies is acute pulmonary diseases such as COPD and acute respiratory distress syndrome. We, and our partners in South Korea, are very excited by the potential to develop life improving treatments for patients with these serious respiratory diseases as well as Covid-19.

Seng-ho Jeon, CEO of Daewoong Pharmaceutical and AffyXell Therapeutics, said:

It is very encouraging that AffyXell now has the opportunity to expand the application of its next-generation stem cell platform technology to target viruses. The SARS-CoV-2 neutralising Affimer to be developed in combination with AffyXells cell and gene technology is expected to be an innovative solution for COVID-19 patients suffering cytokine release syndrome.

Daewoong has been also conducting several research programs and clinical trial for Covid19. As the Covid-19 crisis has caused great difficulties worldwide, we will continue to focus our efforts to develop a novel therapeutic agent for Covid-19.

Read more

Covid-19 test developed by Avacta and Adeptrix to be evaluated by governments CONDOR programme

Avacta and Integumen collaborate to detect Covid-19 in sewage

Avacta signs distribution deal for Covid-19 self-test under development

Avacta confirms Affimer reagents prevent infection of human cells in model of Covid-19 virus

Follow this link:
Avacta extends partnership with Daewoong Pharmaceutical and AffyXell Therapeutics for Covid-19 stem cell treatments - Cambridge Independent

First really effective treatment for multiple sclerosis could be available within five years – iNews

At the moment, treatments help alleviate the symptoms of relapsing-remitting MS, the milder, more common form of the disease (Photo: LINDSEY PARNABY/AFP/Getty)

The first really effective treatment for multiple sclerosis (MS) could be available within five years after researchers raised hopes that they had discovered the holy grail of MS therapy.

Scientists have identified a natural mechanism in the body that could be boosted with an existing diabetes drug to protect against the nerve damage at the centre of the disease.

This would not only halt progression of MS but may partially reverse it as well, they say.

At the moment, treatments help alleviate the symptoms of relapsing-remitting MS, the milder, more common form of the disease although these do little to slow its progression.

Meanwhile, there are no treatments for the more serious form of the condition, known as Primary Progressive MS.

This is an incredibly important discovery one we believe could finally bridge the gap in MS treatment, said Don Mahad, of the University of Edinburgh.

Despite major advances in scientific understanding of MS in the past two decades, there is still no treatment to protect nerve fibres although that could be about to change, Dr Mahad said.

Such protection is the holy grail in MS treatment not only for the relapsing form of MS, which has various options available, but for progressive forms too, where treatment continues to lag behind, he said.

Tests on mice and human cells in a lab suggest the Pioglitazone diabetes drug would be a highly effective treatment.

The drug is now being trialled in humans and Dr Mahad is hopeful that it could be available on the health service within four to five years although he cautions more research is needed to confirm early findings.

Emma Gray, of the MS Society, which part-funded the research, said finding treatments for everyone with MS is now a very real prospect.

We can see a future where nobody needs to worry about MS getting worse.MS treatment could in the near future look completely different, Dr Gray said.

To stop multiple sclerosis from progressing we need treatments that protect nerves from damage a goal that has proved elusive.

In MS the protective coating that surrounds nerves, known as myelin, is damaged and nerves become less energy efficient as a result. Not having the energy they need makes nerves vulnerable to further damage and causes disability over time.

But for the first time researchers have discovered a natural mechanism in the body that tackles this issue. Our discovery shows that nerves respond to myelin damage by increasing the movement of mitochondria the cell powerhouse, which produces energy to the area of damage, said Don Mahad, of Edinburgh University. The researchers are calling the response ARMD, which stands for axonal response of mitochondria to demyelination.

Remarkably, we were able to enhance ARMD and protect these vulnerable nerves using the readily available diabetes drug pioglitazone, said Dr Mahad.

Over the last few decades there have been huge strides in our understanding of MS, and there are now over a dozen effective treatments for people with relapsing MS but these only address damage caused by the immune system. In order to truly stop MS and treat everyone, we need to find ways to both protect nerves from further injury and repair damaged myelin, Dr Mahad said. This is where the new discovery comes in.

The study was welcomed by experts not involved in the research.

This is an important study for our understanding of multiple sclerosis [and] might be an important step towards the development of neuroprotective treatment strategies a major unmet need in multiple sclerosis, said Professor Martin Kerschensteiner of the University of Munich.

The paper, published in Acta Neuropathologica, involved scientists from 15 universities and hospitals around the world.

They include Wellcome Trust-MRC Cambridge Stem Cell Institute, Queen Mary University of London, University of College London, Biomedical Primate Research Centre in the Netherlands, the Mayo College of Medicine and Science in Rochester, US, and the Ohio State University.

The MS Society said that more than 130,000 people in the UK live with the condition, which can be relentless, painful and disabling.

Like any responsible medical association, the MS Society takes great care not to raise false hopes where treatments are concerned.

So when it announces new research with the headline Holy Grail discovery to prevent disability in multiple sclerosis you know its something to take seriously.

Not that the discovery will automatically lead to a breakthrough MS treatment as the society would be the first to acknowledge since many more tests are required to confirm early promise.

But there is definitely a high degree of excitement around the development.

A further stroke of luck is that a potentially effective drug is already available for diabetes.

This reduces the need for extensive safety trials and should speed up the process by which the drug should become available assuming it is found to be effective in large human trials.

All going well and that is by no means a certainty we could see the drug being prescribed for MS within five years, researchers say.

Visit link:
First really effective treatment for multiple sclerosis could be available within five years - iNews

HKUMed researchers first discovered SARS-CoV-2 infects human neural progenitor cells and brain organoids – Mirage News

Researchers at the School of Biomedical Sciences, the Department of Microbiology and the Department of Medicine, LKS Faculty of Medicine of The University of Hong Kong (HKUMed) collaborated with researchers at the Institute of Synthetic Biology of Chinese Academy of Sciences-Shenzhen Institutes of Advanced Technology to conduct a study on SARS-CoV-2 infection of human neural progenitor cells and brain organoids. The results are now published in life sciences journal Cell Research [link to the publication].

Background

Coronavirus disease 2019 (COVID-19) caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1 as resulted in over 17 million confirmed cases and more than 686,703 deaths across 218 countries and geographical regions as of 3 August 2020. This novel coronavirus primarily causes respiratory illness with clinical manifestations largely resembling those of SARS. However, neurological symptoms including headache, anosmia, ageusia, confusion, seizure and encephalopathy have also been frequently reported in COVID-19 patients. In a study of 214 hospitalized COVID-19 patients in Wuhan, Mainland China, neurologic findings were reported in 36.4% of patients, and were more commonly observed in patients with severe infections (45.5%)2. Similarly, a study from France reported neurologic findings in 84.5% (49/58) of COVID-19 patients admitted to hospital3. Most Importantly, a recent study in Germany demonstrated that SARS-CoV-2 RNA could be detected in brain biopsies in 36.4% (8/22) of fatal COVID-19 cases4, which highlights the potential for viral infections in the human brain. To date, there has been no direct experimental evidence of SARS-CoV-2 infection in the human central nervous system (CNS).

Research Findings

To explore the direct involvement of SARS-CoV-2 in the CNS in physiologically relevant models, the research team assessed SARS-CoV-2 infection in induced pluripotent stem cells (iPSCs)-derived human neural progenitor cells (hNPCs), neurospheres and brain organoids.

The results demonstrated that iPSC-derived hNPCs were permissive to SARS-CoV-2 infection, but not SARS-CoV infection. Extensive protein expression and infectious viral particles were detected in neurospheres and brain organoids infected with SARS-CoV-2, which suggest SARS-CoV-2 can productively infect the human brain. Importantly, SARS-CoV-2 infection in 3D human brain organoids was localized to TUJ1 (neuronal marker)- and NESTIN (NPC marker)-positive cells, suggesting SARS-CoV-2 could directly target cortical neurons and NPCs.

Overall, our study provides the first evidence of direct SARS-CoV-2 infection in human brain organoids, which contributes to our understanding on the pathogenesis of neurological complications in COVID-19, said Professor Huang Jian-dong, L & T Charitable Foundation Professor in Biomedical Sciences, School of Biomedical Sciences, HKUMed, who led the research.

He also pointed out that the Zika virus that re-emerged in 2015 is also well recognized to target neural progenitor cells in the human brain, leading to microcephaly and severe developmental defects in the fetus and other neurological anomalies in adults. The research team suggests that the chronic or long-term consequence of SARS-CoV-2 infection on the CNS should be closely monitored.

About the Research Team

The research was led by Prof Huang Jian-dong, L & T Charitable Foundation Professor in Biomedical Sciences, School of Biomedical Sciences, HKUMed, in collaboration with Dr Zhang Bao-zhong at the Institute of Synthetic Biology of Chinese Academy of Sciences-Shenzhen Institutes of Advanced Technology; Prof Ivan Hung Fan-ngai, Ru Chien and Helen Lieh Professor in Health Sciences Pedagogy, Chief of Infectious Diseases Division and Clinical Professor at Department of Medicine, Assistant Dean (Admissions) of HKUMed; Dr Chu Hin, Research Assistant Professor, Department of Microbiology, HKUMed; Dr Jasper Chan Fuk-woo, Clinical Assistant Professor, Department of Microbiology, HKUMed and Prof Yuen Kwok-yung, Henry Fok Professor in Infectious Diseases and Chair of Infectious Diseases, Department of Microbiology, HKUMed.

Acknowledgments

This work was supported by Health and Medical Research Fund (COVID190117) from the Food and Health Bureau of the Government of the Hong Kong Special Administrative Region, the Shenzhen Peacock Plan Team Project, Shenzhen Science and Technology Innovation Committee Basic Science Research Grant.

More here:
HKUMed researchers first discovered SARS-CoV-2 infects human neural progenitor cells and brain organoids - Mirage News

Electromedical Inc. Accelerates Corporate Expansion and Product DevelopmentAnnounces the Opening of First European Office For the Development of New…

SCOTTSDALE, Ariz., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Electromedical Technologies, Inc. (OTC:ELCQ) (the Company), a pioneer in the development and manufacturing of bioelectronic devices, including the FDA cleared WellnessPro, designed to relieve chronic, intractable and acute pains by using frequencies and electro-modulation, is pleased to announce that its Director of Technology, Mr. Petar Gajic, will establish a research and development office in Belgrade, Europe for the creation of new products and technologies.

Matthew Wolfson, CEO of ELCQ, commented, Petar Gajic is currently in Belgrade, Serbia right in the middle of Europe (Nikola Teslas birth-place), a perfect place for engineering talents. He is establishing our first European office for the development of our POD device along with other exciting technologies. Mr. Gajic brings years of experience working in computer technology, electrical engineering and programming fields and later as Director of Technology for Electromedical for the past 15 years.

Commenting further, Mr. Wolfson said, Peter was instrumental in the development of the Wellness Pro product line and now we look forward for him to oversee and manage the opening of our first technology office in Europe, and overseeing the development of our NEW Wellness Pro POD . This will help us expedite the development of the Wellness Pro POD at more cost-efficient rates, so that we can bring the product to market ahead of schedule. We continue to execute on our Product Development roadmap, and are excited to begin our European expansion. Mr Gajic will also coordinate research efforts and will be more efficient in working with Nazarbayev University. https://www.businesswire.com/news/home/20200423005273/en/Electromedical-Technologies-Announces-Research-Collaboration-Nazarbayev-University

Finally, Mr Wolfson said, Pharmacology has dominated most, if not all, medical treatments for centuries. Todays pharmacology is coupled with precision surgery, biologicals, stem cell regeneration technologies and personalized medicine based on genomics. Meanwhile, it is also evident that drugs have their limitations and can cause harmful side effects. There are alternative medical treatments such as electrical bio-modulation therapies, that are just now coming to the forefront of treating pain. Our goal is to bring awareness to the masses of the Wellness Pro product line and its powerful and effective treatments. Aside from establishing our EU research and development under Mr. Gajics direction, we are also focused on the continuing effects of the COVID -19 pandemic on opioid use and abuse here and elsewhere. As reported by CNN, the U.S. Opioid crisis will worsen during and after the pandemic, and we think this is a significant time for our company and products to really offer a drug free alternative and solution without the harmful side effects of opioids. https://www.cnn.com/2020/05/07/health/opioid-epidemic-covid19-pandemic-trnd/index.html

About Electromedical Technologies:

Headquartered in Scottsdale Arizona, Electromedical Technologies, Inc. is a commercial stage, FDA cleared, bioelectronic medical device manufacturing company initially focused on the treatment of various chronic, acute, intractable and post-operative pain conditions. Through university collaboration agreements the company is working to develop a comprehensive research program in defining the effects of electro-modulation on the human body by studying the impacts of electrical fields in cell signaling and effects on virus assembly and immune responses with the goal of improving human wellbeing. The companys current cleared product indications are for chronic acute post traumatic and post-operative, intractable pain relief.

For more information, visit https://electromedtech.com

Safe Harbor Statement:

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance or guarantee that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to: adverse economic conditions, competition, adverse federal, state and local government regulation, international governmental regulation, inadequate capital, inability to carry out research, development and commercialization plans, loss or retirement of key executives and other specific risks. To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.

Electromedical Technologies, Inc. Matthew Wolfson Tel: 1.888.880.7888 email: ceo@electromedtech.com https://electromedtech.com

Read more here:
Electromedical Inc. Accelerates Corporate Expansion and Product DevelopmentAnnounces the Opening of First European Office For the Development of New...

Evolution and Expansion of Therapies in the Global Cell and Gene Therapy Tools and Reagents Market 2020-2024 – PRNewswire

DUBLIN, Aug. 4, 2020 /PRNewswire/ -- The "Cell and Gene Therapy Tools, and Reagents: Global Markets" report has been added to ResearchAndMarkets.com's offering.

Gene and cell therapy are emerging as important tools to treat human health. Techniques such as CAR-T therapy have emerged as key ways of treating many different types of cancers. The promise of gene therapy using technologies such as CRISPR is starting to be realized in clinical trials, and markets are scaling up to treat other diseases as well, particularly rare gene-based diseases. As these therapies are coming to the fore, a new market for tools to develop these therapies using standard methodologies is emerging. This report will cover what those tools are, how they impact the larger life science tools market, and how they will evolve over the next five years.

The scope of this study encompasses an investigation of the market's cell and gene therapy tools such as GMP proteins, media, cell separation and activation reagents, viral and non-viral, cytokine release syndrome monitoring products, GMP antibodies, leukapheresis instrumentation, immunoassays (multiplex and singleplex) and bioreactors. This research analyzes each tool type, determines its current market status, examines its impact on future markets, and presents forecasts of growth over the next five years. Technological issues, including the latest trends, are discussed. The report analyzes the industry on a worldwide basis, from both application and demand perspectives, in the major regions of the world.

The Report Includes:

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market and Technology Background

Chapter 4 Market Breakdown by Region

Chapter 5 Market Breakdown by End User

Chapter 6 Government Regulations

Chapter 7 Patent Review/New Developments

Chapter 8 Analysis of Market Opportunities

Chapter 9 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/p5fqx6

About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

http://www.researchandmarkets.com

See the original post:
Evolution and Expansion of Therapies in the Global Cell and Gene Therapy Tools and Reagents Market 2020-2024 - PRNewswire

CAREDX : MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) – marketscreener.com

The following discussion and analysis of our financial condition and results ofoperations should be read together with the unaudited condensed consolidatedfinancial statements and related notes included elsewhere in Item 1 of Part I ofthis Quarterly Report on Form 10-Q and with the audited consolidated financialstatements and the related notes included in our Annual Report on Form 10-K forthe fiscal year ended December 31, 2019, filed with the Securities and ExchangeCommission, or the SEC, on February 28, 2020.SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTSThis Quarterly Report on Form 10-Q contains forward-looking statements withinthe meaning of Section 27A of the Securities Act of 1933, as amended, andSection 21E of the Securities Exchange Act of 1934, as amended. All statementscontained in this Quarterly Report on Form 10-Q other than statements ofhistorical fact, including statements regarding our future results of operationsand financial position, our business strategy and plans, and our objectives forfuture operations, are forward-looking statements. The words "believe," "may,""will," "potentially," "estimate," "continue," "anticipate," "intend," "could,""should," "would," "project," "plan," "target," "contemplate," "predict,""expect" and the negative and plural forms of these words and similarexpressions are intended to identify forward-looking statements.These forward-looking statements may include, but are not limited to, statementsconcerning the following:the potential impact to our business, revenue, financial condition andemployees, including disruptions to our testing services, laboratories, clinicaltrials, supply chain and operations, due to the COVID-19 global pandemic;our ability to take advantage of opportunities under the Coronavirus Aid,Relief, and Economic Security Act, or the CARES Act, and the potential impact ofthe CARES Act on our business, results of operations, financial condition orliquidity;our ability to generate revenue and increase the commercial success of ourcurrent and future testing services, products and digital solutions;our ability to obtain, maintain and expand reimbursement coverage from payersfor our current and other future testing services, if any;our plans and ability to continue updating our testing services, products anddigital solutions to maintain our leading position in transplantations;the outcome or success of our clinical trial collaborations and registrystudies; including Kidney Allograft Outcomes AlloSure Registry, or K-OAR, theOutcomes of KidneyCare on Renal Allografts registry study, or OKRA, and theSurveillance HeartCare Outcomes Registry, or SHORE;the favorable review of our testing services and product offerings, and ourfuture solutions, if any, in peer-reviewed publications;our ability to obtain additional financing on terms favorable to us, or at all;our anticipated cash needs and our anticipated uses of our funds, including ourestimates regarding operating expenses and capital requirements;anticipated trends and challenges in our business and the markets in which weoperate;our dependence on certain of our suppliers, service providers and otherdistribution partners; 25-------------------------------------------------------------------------------- Table of Contentsdisruptions to our business, including disruptions at our laboratories andmanufacturing facilities;our ability to retain key members of our management team;our ability to make successful acquisitions or investments and to manage theintegration of such acquisitions or investments;our ability to expand internationally;our compliance with federal, state and foreign regulatory requirements;our ability to protect and enforce our intellectual property rights, ourstrategies regarding filing additional patent applications to strengthen ourintellectual property rights, and our ability to defend against intellectualproperty claims that may be brought against us;our ability to successfully assert, defend against or settle any litigationbrought by or against us or other legal matters or disputes; andour ability to comply with the requirements of being a public company.These forward-looking statements are subject to a number of risks, uncertaintiesand assumptions, including those described in the section entitled "RiskFactors" in this Quarterly Report on Form 10-Q and in our Annual Report on Form10-K for the fiscal year ended December 31, 2019, filed with the SEC onFebruary 28, 2020. Moreover, we operate in a very competitive and rapidlychanging environment, and new risks emerge from time to time. It is not possiblefor our management to predict all risks, nor can we assess the impact of allfactors on our business or the extent to which any factor, or combination offactors, may cause actual results to differ materially and adversely from thosecontained in any forward-looking statements we may make. In light of theserisks, uncertainties and assumptions, the forward-looking events andcircumstances discussed in this report may not occur and actual results coulddiffer materially and adversely from those anticipated or implied in theforward-looking statements.You should not rely upon forward-looking statements as predictions of futureevents. Although we believe that the expectations reflected in theforward-looking statements are reasonable, we cannot guarantee that the futureresults, levels of activity, performance or events and circumstances reflectedin the forward-looking statements will be achieved or occur. Moreover, neitherwe nor any other person assumes responsibility for the accuracy and completenessof the forward-looking statements. Except as required by law, we undertake noobligation to update publicly any forward-looking statements for any reasonafter the date of this report to conform these statements to actual results orto changes in our expectations.You should read this Quarterly Report on Form 10-Q and the documents that wereference in this Quarterly Report on Form 10-Q and have filed with the SEC asexhibits to this Quarterly Report on Form 10-Q with the understanding that ouractual future results, levels of activity, performance and events andcircumstances may be materially different from what we expect. We qualify allforward-looking statements by these cautionary statements.Overview and Recent HighlightsCareDx, Inc. (collectively, the "Company", "we", "us" and "our") is a leadingprecision medicine company focused on the discovery, development andcommercialization of clinically differentiated, high-value diagnostic solutionsfor transplant patients and caregivers. We offer testing services, products, anddigital healthcare solutions along the pre- and post-transplant patient journey,and we are a leading provider of genomics-based information for transplantpatients.Highlights for the Three Months Ended June 30, 2020 and Recent HighlightsAchieved total revenue of $41.8 million for the three months ended June 30,2020, increasing 33% year-over-yearProvided over 17,100 AlloSure Kidney and AlloMap Heart patient results, withover 40% originating from RemoTraC and mobile phlebotomyRecorded first-ever AlloCell revenue from a cell therapy partnershipCompleted successful public offering raising $134.6 million in net proceeds,increasing cash and cash equivalents to approximately $211.4 millionTesting ServicesHeart 26-------------------------------------------------------------------------------- Table of ContentsAlloMap Heart is a gene expression test that helps clinicians monitor andidentify heart transplant recipients with stable graft function who have a lowprobability of moderate-to-severe acute cellular rejection. Since 2008, we havesought to expand the adoption and utilization of our AlloMap Heart solutionthrough ongoing studies to substantiate the clinical utility and actionability,secure positive reimbursement decisions from large private and public payers,develop and enhance our relationships with key members of the transplantcommunity, including opinion leaders at major transplant centers, and exploreopportunities and technologies for the development of additional solutions forpost-transplant surveillance.We believe the use of AlloMap Heart, in conjunction with other clinicalindicators, can help healthcare providers and their patients better managelong-term care following a heart transplant, can improve patient care by helpinghealthcare providers avoid the use of unnecessary, invasive surveillancebiopsies and may help to determine the appropriate dosage levels ofimmunosuppressants. In 2008, AlloMap Heart received 510(k) clearance from theU.S. Food and Drug Administration for marketing and sale as a test to aid in theidentification of heart transplant recipients, who have a low probability ofmoderate/severe acute cellular rejection at the time of testing, in conjunctionwith standard clinical assessment.AlloMap Heart has been a covered service for Medicare beneficiaries sinceJanuary 1, 2006. The Medicare reimbursement rate for AlloMap Heart is currently$3,240. AlloMap Heart has also received positive coverage decisions forreimbursement from many of the largest U.S. private payers, including Aetna,Anthem, Cigna, Health Care Services Corporation, or HCSC, Humana, KaiserFoundation Health Plan, Inc. and UnitedHealthcare.We have also successfully completed a number of landmark clinical trials in thetransplant field demonstrating the clinical utility of AlloMap Heart forsurveillance of heart transplant recipients. We initially established theanalytical and clinical validity of AlloMap Heart on the basis of our CardiacAllograft Rejection Gene Expression Observational (Deng, M. et al., Am JTransplantation 2006), or CARGO, study, which was published in the AmericanJournal of Transplantation. A subsequent clinical utility trial, InvasiveMonitoring Attenuation through Gene Expression (Pham MX et al., N. Eng. J. Med.,2010), or IMAGE, published in The New England Journal of Medicine, demonstratedthat clinical outcomes in recipients managed with AlloMap Heart surveillancewere equivalent (non-inferior) to outcomes in recipients managed withbiopsies. The results of our clinical trials have also been presented at majormedical society congresses. AlloMap Heart is now recommended as part of theInternational Society for Heart and Lung Transplantation, or ISHLT, guidelines.HeartCareHeartCare includes the gene expression profiling technology of AlloMap Heartwith the dd-cfDNA analysis of AlloSure Heart in one surveillance solution. Anapproach to surveillance using HeartCare provides information from twocomplementary measures: (i) AlloMap Heart - a measure of immune activation, and(ii) AlloSure Heart - a measure of graft injury.Clinical validation data from the Donor-Derived Cell-Free DNA-Outcomes AlloMapRegistry (NCT02178943), or D-OAR, was published in American Journal ofTransplant, or AJT, in 2019. D-OAR was an observational, prospective,multicenter study to characterize the AlloSure-Heart dd-cfDNA in a routine,clinical surveillance setting with heart transplant recipients. The D-OAR studywas designed to validate that plasma levels of AlloSure-Heart dd-cfDNA candiscriminate acute rejection from no rejection, as determined by endomyocardialbiopsy criteria.HeartCare provides robust information about distinct biological processes, suchas immune quiescence, active injury, Acute Cellular Rejection, or ACR, andAntibody Mediated Rejection. In September 2018, we initiated the SHORE study.SHORE is a prospective, multi-center, observational, registry of patientsreceiving HeartCare for surveillance. Patients enrolled in SHORE will befollowed for 5 years with collection of clinical data and assessment of 5-yearoutcomes.In August 2019, AlloSure Heart received a positive draft Local CoverageDetermination for Medicare coverage. We have not yet made any applications toprivate payers for reimbursement coverage of AlloSure Heart.KidneyAlloSure Kidney, our transplant surveillance solution, which was commerciallylaunched in October 2017, is our donor-derived cell-free DNA, or dd-cfDNA,offering built on a Next Generation Sequencing, or NGS, platform. Intransplantation, 109 papers from 55 studies globally have shown the value ofdd-cfDNA in the management of solid organ transplantation. AlloSure allowssequencing of DNA and RNA much more quickly than the previously used Sangersequencing. AlloSure is able to discriminate dd-cfDNA from recipient-cell-freeDNA, targeting polymorphisms between donor and recipient. This single-nucleotidepolymorphism, or SNPs, approach across all the somatic chromosomes isspecifically designed for transplantation, allowing a scalable, high-qualitytest to differentiate dd-cfDNA.AlloSure Kidney has received positive coverage decisions for reimbursement fromMedicare. The Medicare reimbursement rate for AlloSure Kidney is $2,841.AlloSure Kidney has also received positive coverage decisions from BCBS SouthCarolina and BCBS Kansas City, and is reimbursed by other private payers on acase-by-case basis. 27-------------------------------------------------------------------------------- Table of ContentsMultiple studies have demonstrated that significant allograft injury can occurin the absence of changes in serum creatinine. Thus, clinicians have limitedability to detect injury early and intervene to prevent long term damage usingthis marker. While histologic analysis of the allograft biopsy specimen remainsthe standard method used to assess injury and differentiate rejection from otherinjury in kidney transplants, as an invasive test with complications, repetitivebiopsies are not well tolerated. AlloSure provides a non-invasive test,assessing allograft injury that enables more frequent, quantitative and saferassessment of allograft rejection and injury status. Beyond allograft rejection,the assessment of molecular inflammation has shown further utility in theassessment of proteinuria, formation of De Novo donor specific antibodies, orDSAs, and also as a surrogate predictive measure of estimated glomerularfiltration rate, or eGFR, decline. Monitoring of graft injury through AlloSureallows clinicians to optimize allograft biopsies, identify allograft injury andguide immunosuppression management more accurately.Since the analytical validation paper in the Journal of Molecular Diagnostics in2016 before the commercial launch of AlloSure Kidney, an increasing body ofevidence supports the use of AlloSure dd-cfDNA in the assessment andsurveillance of kidney transplants. Bloom et al evaluated 102 kidney recipientsand demonstrated that dd-cfDNA levels could discriminate accurately andnon-invasively distinguish rejection from other types of graft injury. Incontrast, serum creatinine has area under the curve, or AUC, of 50%, showing nosignificant difference between patients with and without rejection. Multiplepublications and abstracts have shown AlloSure's value in the management of BKviremia, as well as numerous pathologies that cause molecular inflammation andinjury such as DSAs and eGFR decline. Most recently its utility in theassessment of T-cell mediated rejection (TCMR) 1A and borderline rejection hasalso been published in the AJT.The prospective multicenter trial: Kidney Allograft Outcomes AlloSure KidneyRegistry, or the K-OAR study, is currently ongoing and has enrolled over 1,600patients, with plans to survey patients with AlloSure for 3 years and providefurther clinical utility of AlloSure Kidney in the surveillance of kidneytransplant recipients.KidneyCareKidneyCare combines the dd-cfDNA analysis of AlloSure Kidney with the geneexpression profiling technology of AlloMap Kidney and the predictive artificialintelligence technology of KidneyCare iBox in one surveillance solution. We havenot yet made any applications to payers for reimbursement coverage of AlloMapKidney or KidneyCare iBox.In September 2019, we announced the enrollment of the first patient in the OKRAstudy, which is an extension of the K-OAR study. OKRA is a prospective,multi-center, observational registry of patients receiving KidneyCare forsurveillance. Combined with K-OAR, 4,000 patients will be enrolled into thestudy.LungIn February 2019, AlloSure Lung became available for lung transplant patientsthrough a compassionate use program while the test is undergoing furtherstudies. AlloSure Lung applies proprietary NGS technology to measure dd-cfDNAfrom the donor lung in the recipient bloodstream to monitor graft injury. Wehave not yet made any applications to payers for reimbursement coverage ofAlloSure Lung.Cellular TherapyIn April 2020, we initiated a research partnership for AlloCell, a surveillancesolution that monitors the level of engraftment and persistence of allogeneiccells for patients who have received cell therapy transplants. AlloCell willinitially be commercialized through collaborative research agreements withbiopharma companies developing cell therapies.ProductsWe develop, manufacture, market and sell products that increase the chance ofsuccessful transplants by facilitating a better match between a solid organ orstem cell donor and a recipient, and help to provide post-transplantsurveillance of these recipients.QTYPE enables Human Leukocyte Antigen or HLA typing at a low to intermediateresolution for samples that require a fast turn-around-time and uses real-timepolymerase chain reaction, or PCR, methodology. Olerup SSP is used to type HLAalleles based on the sequence specific primer, or SSP, technology. Olerup SBT isa complete product range for sequence-based typing of HLA alleles.On May 4, 2018, we entered into a license agreement with Illumina, Inc., or theIllumina Agreement, which provides us with worldwide distribution, developmentand commercialization rights to Illumina's NGS products and technologies for usein transplantation diagnostic testing.On June 1, 2018, we became the exclusive worldwide distributor of Illumina'sTruSight HLA product line. TruSight HLA is a high-resolution solution that usesNGS methodology. In addition, we were granted the exclusive right to develop andcommercialize other NGS product lines in the field of bone marrow and solidorgan transplantation on diagnostic testing. These 28-------------------------------------------------------------------------------- Table of ContentsNGS products include: AlloSeq Tx, a high-resolution HLA typing solution, AlloSeqcfDNA, our surveillance solution designed to measure dd-cfDNA in blood to detectactive rejection in transplant recipients, and AlloSeq HCT, a NGS solution forchimerism testing for stem cell transplant recipients.In September 2019, we commercially launched AlloSeq cfDNA, our surveillancesolution designed to measure dd-cfDNA in blood to detect active rejection intransplant recipients, and we received CE mark approval on January 10, 2020. Ourability to increase the clinical uptake for AlloSeq cfDNA will be a result ofmultiple factors including local clinical education, customer lab technicalproficiency and levels of country-specific reimbursement.Also in September 2019, we commercially launched AlloSeq Tx, the first of itskind NGS high-resolution HLA typing solution utilizing hybrid capturetechnology. This technology enables the most comprehensive sequencing, coveringmore of the HLA genes than current solutions and adding coverage of non-HLAgenes that may impact transplant patient matching and management. AlloSeq Tx hassimple NGS workflow, with a single tube for processing and steps to reduceerrors. AlloSeq Tx 17 received CE mark approval on May 15, 2020.In June 2020, we commercially launched AlloSeq HCT, a NGS solution for chimerismtesting for stem cell transplant recipients. This technology can provide bettersensitivity and data analysis compared to current solutions on the market.DigitalIn 2019, we began providing digital solutions to transplant centers followingthe acquisition of Ottr Complete Transplant Management, or OttrCare, andXynManagement, Inc., or XynManagement.On May 7, 2019, we acquired 100% of the outstanding common stock of OttrCare.OttrCare was formed in 1993 and is a leading provider of transplant patienttracking software, or the Ottr software, which provides comprehensive solutionsfor transplant patient management. The Ottr software enables integration withelectronic medical records, systems, including Cerner and Epic, providingpatient surveillance management tools and outcomes data to transplant centers.On August 26, 2019, we acquired 100% of the outstanding common stock ofXynManagement. XynManagement provides two unique solutions, XynQAPI software, orXynQAPI, and Waitlist Management. XynQAPI simplifies transplant quality trackingand Scientific Registry of Transplant Recipients, or SRTR, reporting. WaitlistManagement includes a team of transplant assistants who maintain regular contactwith patients on the waitlist to help prepare for their transplant and maintaineligibility.COVID-19 ImpactIn the final weeks of March and during April 2020, with hospitals increasinglycaring for COVID-19 patients, hospital administrators chose to limit or evendefer, non-emergency procedures. Immunosuppressed transplant patients eitherself-prescribed or were asked to avoid transplant centers and caregiver visitsto reduce the risk of contracting COVID-19. As a result, with transplantsurveillance visits down, we experienced a slowdown in testing services volumesin the final weeks of March and during April 2020. As a response to the COVID-19pandemic, and to enable immune-compromised transplant patients to continue tohave their blood drawn, in late March 2020 we launched RemoTraC, a remotehome-based blood draw solution using mobile phlebotomy for AlloSure and AlloMapsurveillance tests, as well as for other standard monitoring tests. To date,more than 150 transplant centers can offer RemoTraC to their patients and over4,000 kidney, heart, and lung transplant patients have enrolled. Based onexisting and new relationships with partners, we have established a nationwidenetwork of more than 10,000 mobile phlebotomists. Following the introduction ofRemoTraC and with the easing of stay-at-home restrictions and the opening up ofmany hospitals to non-COVID-19 patients, our testing services volumes returnedto levels consistent with those experienced immediately prior to the impact ofCOVID-19, and volumes continued to be at or above those levels throughout May2020 and June 2020. However, our product business experienced a reduction inforecasted sales volume throughout the second quarter 2020, as we were unable toundertake onsite discussions and demonstrations of our recently launched NGSproducts, including AlloSeq Tx 17, which was awarded CE mark approval in May2020.We are maintaining our testing, manufacturing, and distribution facilities whileimplementing specific protocols to reduce contact among our employees. In areaswhere COVID-19 impacts healthcare operations, our field-based sales and clinicalsupport teams are supporting providers through telephone and online platforms.To reduce the risk to employees and their families from potential exposure toCOVID-19, most of our corporate employees have been asked to work from home. Wehave also restricted non-essential business travel to protect the health andsafety of its employees, patients, and customers. In addition, we have created aCOVID-19 task force that is responsible for crisis decision making, employeecommunications, enforcing pre-arrival temperature checking, daily healthcheck-ins and enhanced safety training/protocols in our offices for employeesthat cannot work from home.Due to COVID-19, quarantines, shelter-in-place and similar government orders, orthe perception that such orders, shutdowns or other restrictions on the conductof business operations could occur or could impact personnel at third-partysuppliers in the United States and other countries, or the availability or costof materials, there may be disruptions in our supply chain. Any 29-------------------------------------------------------------------------------- Table of Contentsmanufacturing supply interruption of materials could adversely affect ourability to conduct ongoing and future research and testing activities.In addition, our clinical studies may be affected by the COVID-19 pandemic.Clinical site initiation and patient enrollment may be delayed due toprioritization of hospital resources toward the COVID-19 pandemic. Some patientsmay not be able to comply with clinical study protocols if quarantines impedepatient movement or interrupt healthcare services. Similarly, the ability torecruit and retain patients and principal investigators and site staff who, ashealthcare providers, may have heightened exposure to COVID-19, may adverselyimpact our clinical trial operations.Financial Operations OverviewRevenueWe derive our revenue from testing services, products sales and digital andother revenues. Revenue is recorded considering a five-step revenue recognitionmodel that includes identifying the contract with a customer, identifying theperformance obligations in the contract, determining the transaction price,allocating the transaction price to the performance obligations and recognizingrevenue when, or as, an entity satisfies a performance obligation.Testing Services RevenueOur testing services revenue is derived from AlloSure Kidney and AlloMap Hearttests, which represented 87% and 84% of our total revenues for the three and sixmonths ended June 30, 2020, respectively, and 82% of our total revenues for eachof the three and six months ended June 30, 2019. Our testing services revenuedepends on a number of factors, including (i) the number of tests performed;(ii) establishment of coverage policies by third-party insurers and governmentpayers; (iii) our ability to collect from payers with whom we do not havepositive coverage determination, which often requires that we pursue acase-by-case appeals process; (iv) our ability to recognize revenues on testsbilled prior to the establishment of reimbursement policies, contracts orpayment histories; (v) our ability to expand into markets outside of the UnitedStates; and (vi) how quickly we can successfully commercialize new productofferings.We currently market testing services to healthcare providers through our directsales force that targets transplant centers and their physicians, coordinatorsand nurse practitioners. The healthcare providers that order the tests and onwhose behalf we provide our testing services are generally not responsible forthe payment of these services. Amounts received by us vary from payer to payerbased on each payer's internal coverage practices and policies. We generallybill third-party payers upon delivery of a test result report to the orderingphysician. As such, we take the assignment of benefits and the risk ofcollection from the third-party payer and individual patients.In April 2020, we announced our first biopharma research partnership forAlloCell, a surveillance solution that monitors the level of engraftment andpersistence of allogeneic cells for patients who have received cell therapytransplants. AlloCell will initially be commercialized through collaborativeresearch agreements with biopharma companies developing cell therapies.Product RevenueOur product revenue is derived primarily from sales of Olerup SSP, QTYPE,TruSight and AlloSeq Tx products. Product revenue represented 8% and 10% oftotal revenue for the three and six months ended June 30, 2020, respectively,and 15% and 16% of total revenue for the three and six months ended June 30,2019, respectively. We recognize product revenue from the sale of products toend-users, distributors and strategic partners when all revenue recognitioncriteria are satisfied. We generally have a contract or a purchase order from acustomer with the specified required terms of order, including the number ofproducts ordered. Transaction prices are determinable and products are deliveredand risk of loss passed to the customer upon either shipping or delivery, as perthe terms of the agreement. There are no further performance obligations relatedto a contract and revenue is recognized at the point of delivery consistent withthe terms of the contract or purchase order.Digital and Other RevenueOur digital and other revenue is mainly derived from sales of our Ottr softwareand XynQAPI licenses and services and other licensing agreements. Digital andother revenue represented 5% and 6% of total revenue for the three and sixmonths ended June 30, 2020, respectively, and 4% and 2% of total revenue for thethree and six months ended June 30, 2019, respectively.Critical Accounting Policies and Significant Judgments and EstimatesOur management's discussion and analysis of our financial condition and resultsof operations is based on our unaudited condensed consolidated financialstatements, which have been prepared in accordance with United States generallyaccepted accounting principles. The preparation of these unaudited condensedconsolidated financial statements requires us to make estimates and assumptionsthat affect the reported amounts of assets and liabilities and the disclosure ofcontingent assets and liabilities at the date of the unaudited condensedconsolidated financial statements, as well as the reported revenue generated 30-------------------------------------------------------------------------------- Table of Contentsand expenses incurred during the reporting periods. Our estimates are based onour historical experience and on various other factors that we believe arereasonable under the circumstances, the results of which form the basis formaking judgments about the carrying value of assets and liabilities that are notreadily apparent from other sources. Actual results may differ from theseestimates under different assumptions or conditions.We believe that the following critical accounting policies reflect the moresignificant estimates and assumptions used in the preparation of our financialstatements. We believe the following critical accounting policies are affectedby significant judgments and estimates used in the preparation of our unauditedcondensed consolidated financial statements:Revenue recognition;Business combination;Acquired intangible assets;Impairment of goodwill, intangible assets and other long-lived assets; andCommon stock warrant liability.There were no material changes in the matters for which we make criticalaccounting estimates in the preparation of our unaudited condensed consolidatedfinancial statements during the three and six months ended June 30, 2020 ascompared to those disclosed in Management's Discussion and Analysis of FinancialCondition and Results of Operations included in our annual report on Form 10-Kfor the year ended December 31, 2019, except that there is no derivativeliability outstanding as of December 31, 2019 and June 30, 2020 and thedetermination of the estimated present value of lease payments using ourincremental borrowing rate as discussed in Note 2, Summary of SignificantAccounting Policies, in the unaudited condensed consolidated financialstatements included elsewhere in this Quarterly Report on Form 10-Q.Recently Issued Accounting StandardsRefer to Note 2, Summary of Significant Accounting Policies - Recent AccountingPronouncements, to the unaudited condensed consolidated financial statementsincluded elsewhere in this Quarterly Report on Form 10-Q for a description ofrecently issued accounting pronouncements, including the expected dates ofadoption and estimated effects on our results of operations, financial positionand cash flows. 31-------------------------------------------------------------------------------- Table of ContentsResults of OperationsComparison of the Three Months Ended June 30, 2020 and 2019(In thousands) Three Months Ended June 30, 2020 2019 ChangeRevenue:Testing services revenue $ 36,293$ 25,677$ 10,616Product revenue 3,291 4,593 (1,302)Digital and other revenue 2,217 1,184 1,033Total revenue 41,801 31,454 10,347Cost of revenue 15,025 11,512 3,513Gross profit 26,776 19,942 6,834Operating expenses:Research and development 13,129 7,630 5,499Sales and marketing 12,134 10,644 1,490General and administrative 12,316 8,512 3,804Total operating expenses 37,579 26,786 10,793Loss from operations (10,803) (6,844) (3,959)Other income (expense):Interest income, net 21 300 (279)

Change in estimated fair value of common stock warrant liability

Change in estimated fair value of common stock warrant liability

Effect of exchange rate changes on cash, cash equivalents and restricted cash

--------------------------------------------------------------------------------

Edgar Online, source Glimpses

Continued here:
CAREDX : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) - marketscreener.com

The Trouble With CRISPR – Strand

CRISPR is a catchy acronym that originally described a naturally occurring gene editing tool, derived from a bacterial defense mechanism against viruses. Its the name on everybodys lips in the intersecting realms of science, medicine, ethics, and politics. From the moment of its discovery, CRISPR-Cas9 looked like a miraculous solution to all of the problems that gene editing efforts have experienced over decades of trial and error. This revolutionary new gene editing technique has opened the doors to both massive scientific progress and ethical controversy. Now more than ever, were seeing that CRISPR still has massive kinks to work out. Can we ever fully understand the social and scientific implications of gene editing, and should we use it in humans before we learn how to properly harness it?

What is gene editing?

The 20th century saw genetic scientists increasingly focus their pursuits on the sub-microscopic. As science delved deeper into the human body in an attempt to uncover the molecular minutiae of life, the possibility of reaching into the cell and manipulating its genetic material began to look more and more real. Even by the 1950s, evidence had been mounting for decades that deoxyribonucleic acid (DNA), an unassuming molecule residing in a central cellular compartment called the nucleus, was the physical genetic material that passed information from parent to child. Finally, in 1953, landmark work by Kings College biochemist Rosalind Franklin allowed Cambridge researchers to reveal the structure of DNA and confirm its role in heredity once and for all.

Starting from a hesitant foundation, molecular genetics exploded in both scope and popularity over subsequent decades. With the secrets of heredity increasingly out in the open, human ambition demanded that we try to bend DNA to our willand now we can. These days, targeted gene editing techniques revolve around artificially-engineered molecular tools known as nucleases, whose earliest use was in 1996not even 50 years after the discovery of DNAs structure. Engineered nucleases are often described as molecular scissors. Fundamentally, they have two main parts: one part that finds and grabs onto the target DNA within a cell, and one part that snips a piece out of that DNA.

How CRISPR works

CRISPR is similar to other directed nucleases, but its much better at its job. The CRISPR part is secondary to the systems gene editing applications; the truly important discovery, which Jennifer Doudna made in 2012, was a protein that she called CRISPR-associated protein 9, or Cas9. This protein is the nuclease tool, the pair of molecular scissors that finds, sticks to, and snips target DNAand its more accurate than anything weve ever seen before.

In bacteria, CRISPR is a section of the genome that acts as an immune memory, storing little snippets of different viruses genetic material as DNA after failed infections, like trophies. When a once-active virus attempts to invade a bacterium, the mobile helper Cas9 copies down the relevant snippet from CRISPR in the form of ribonucleic acid, or RNA. RNA is a molecule thats virtually identical to DNA, except for one extra oxygen atom. Because of this property, the RNA sequence that Cas9 holds can pair exactly, nucleotide by nucleotide, with the viral targets DNA, making it extremely efficient at finding that DNA. With a freshly transcribed RNA guide, the bacterium can deploy Cas9 to findand cut outthe corresponding section of viral genetic material, rendering the attacker harmless.

The existence of CRISPR in bacteria was old news by 2012, but Doudnas discovery of Cas9s function was revolutionary. With a little creativity and ingenuity, such a simple and accurate nuclease can be modified to be much more than just a pair of scissors. Using synthetic RNA guides and certain tweaks, Cas9 can be used to remove specific genes, cause new insertions to genomes, tag DNA sequences with fluorescent probes, and much more.

The possibilities seem endless.What if we could go into the body of a human affected by a hereditary disease and change that persons DNA to cure them? What if we could modify reproductive germ cells in human bodies (which give rise to sperm and eggs), or make targeted genetic edits in the very first cell of an embryo? Nine months of division and multiplication later, that cell would give rise to a human being whose very nature has been deliberately tweakedand their childrens nature, and their childrens. With the accuracy and accessibility of the CRISPR/Cas9 system, these ideas arent hypotheticals. In 2019, CRISPR edits in bone marrow stem cells were successfully used to cure sickle cell anemia in a Mississippi woman. Beta thalassaemia, another genetic disease of the blood, has also been treated this way. In 2018, Chinese scientist He Jiankui even claimed that he had conferred HIV immunity upon twin girls using embryonic editing.

CRISPRs complications

At first glance, CRISPR looks like a miraclebut it isnt perfect. What if some cells were affected by edits, but others werent, creating a strange genetic mosaic in a human body? What if, in trying to modify a specific gene, we accidentally hit a different section of DNA nearby? What if we got the right gene, but it also affected a different part of the body that we didnt know about?

These problems arent hypotheticals either. So-called mosaicism and off-target editing are huge concerns among CRISPR scientists. Mosaicism is of particular concern in embryonic editing. Though CRISPR injections are carried out when an embryo is single-celled, CRISPR doesnt always appear to work until after several rounds of cell divisionand it doesnt work in every cell. If not all the cells in the body are affected by gene editing that is intended to eliminate a genetic disease, the disease could remain in the body. It may be possible to combat mosaicism with faster gene editing (so that cells dont replicate before theyve had a chance to become CRISPR-modified), altering sperm and egg cells before they meet to form an embryo, and developing more precise CRISPR gene editing which is in itself a challenge, thanks to off-target editing.

In nature, a little bit of off-target editing could actually make the CRISPR-Cas9 defense system stronger with the principle of redundancy. Flexibility in the form of imprecision could allow a bacterium to neutralize viruses whose exact genetic sequences have not yet been encountered: viruses related to, but not identical to, previous attackers. In clinical and therapeutic applications, on the other hand, precision is everything. And unfortunately, as time passes, CRISPRs level of precision seems further and further off. Preprints released just this year reveal that the frequency and magnitude of CRISPRs off-target edits in human cells may be worse than we had previously known. Large proportions of cells with massive unwanted DNA deletions, losses of entire chromosomes in experimental embryos, and shuffling of genetic sequences were observed.

Of course, not only do scientists need to avoid off-target edits, but they also need to know when such undesired edits have occurred. Off-target effects can be detected by genome sequencing and computer prediction tools, but theres no perfect way to do it yetthere may still be editing misses that were, well, missing. Off-target edits themselves could be minimized by altering the RNA transcript that Cas9 carries to make it more accurate, altering Cas9 itself, or reducing the actual amount of Cas9 protein released into the cell (though this could also reduce on-target effects). Replacing Cas9 itself with other Cas variants, like smaller and more easily deliverable CasX and CasY proteins, is a promising possibility for more efficient editing, but these candidates still run into many of the same problems as Cas9. More strategies are constantly being discovered, proposed, and explored, but were still nowhere near perfect.

Perhaps most importantly, even barring any purely technical problems, is that humans remain in sheer ignorance of much of the extent and consequences of pleiotropy, a phenomenon where a genes presence or deletion has more than one effect in the human body. Even genes whose function we think we know well might have totally unexpected additional functions. On the other side of the coin, we dont have a comprehensive understanding of how many different genetic contributors there are to any given trait or disease, much less where they lie in the genome. We dont understand the way that thousands of variations across the entire genome contribute to appearance, personality, and health. Assuming that some genes are good and others are bad is morally dangerous, and scientifically reprehensible. In reality, we are not ready for genetic determinism, and may never be.

A great responsibility

Humanity has discovered a great power, but we all know what comes with great power. Questions of which edits are necessary for health (is mild Harlequin syndrome a disease or a cosmetic concern?), whether edits are ethical (should autism and homosexuality be considered curable conditions?), and the possibility of designer babies, among others, are pertinent and require thorough discussion. We also need to realize that making these types of changes isnt our decision until we can get CRISPR right, and understand the genome well enough to target particular phenotypes. Though most scientists are aware of the difficulties of CRISPR and its use is generally tightly regulated, some scientistsand laypeopleare less careful. He Jiankuis apparent miracle HIV cure led to his arrest and imprisonment for unapproved and unethical practice. Its no great surprise that his work likely fell prey to off-target effects and mosaicism; even if he got it right, his intended change could alter cognitive function, and who knows what else?

Non-scientists are getting involved too: in 2018, self-proclaimed biohacker Josiah Zayner publicly injected his own arm with what he claimed was muscle-enhancing CRISPR. Though Zayner is one of the most vocal, hes not the only one of his kind. Quieter biohackers, untrained people without a scientific background or a good understanding of how CRISPR can go wrong, are attempting to edit themselves and even their pets.

Laypeople have an unquestionable place in science: the scientific discipline needs fresh perspectives and creativity that stuffy academics cant offer. CRISPR is still in its infancy, though. Before we know much, much more about its capabilities and consequences, there can be no place for black market gene editing kits, rogue scientists altering human embryonic and germline DNA, or basement geneticists injecting Cas9 into their dogs. Who can say what effects these interventions might have, not just on edited individuals, but on the futures of entire species?

Some say that gene editing is an act of hubris, destined to backfire spectacularly and horrendously. Others believe that its our responsibility to use CRISPR to improve lives. Which of these opinions is true depends on how science walks a narrow tightrope, though Im inclined to agree with the latterand add that our responsibility is not just to master gene editing, but to make clear and public its many faults and failings. The truth, in all its complexity, needs to overcome pop sciences oversimplification and sensationalism. Promising new advances and techniques are on the horizon, but we have a long way to go. Gene editing is no joke; humanity is playing with fire. With an incredibly accurate and accessible nuclease making its way into labs and garages across the world (while its flaws continue to be uncovered year by year), it is more important than ever for the world to understand and discuss the long-reaching consequences and responsible use of gene editing technology. CRISPR is not a miracle, but gene editing may very well be the future of humanityand its on us to keep it under control.

Read the original:
The Trouble With CRISPR - Strand