BGI’s RT-PCR SARS-CoV-2 Test to Detect Novel Coronavirus Now Commercially Available for Clinical Use in the United States

March 18, 2020

BGI is submitting a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its SARS-CoV-2 test and expects to receive formal EUA in the near future. BGI has been in regular communication with the FDA about its testing data since submitting information to the agency more than a week ago.

“We appreciate the FDA’s move to open up the market for our diagnostic test kits,” said BGI Genomics CEO Yin Ye. “Our goal is to deploy our maximum capability to support efforts to contain the virus worldwide. Our technology has been put to the test on the front lines of fighting this novel coronavirus outside the US. We are now bringing rapid and accurate testing capability at scale to bolster detection efforts throughout the US and help more patients receive accurate diagnosis.”

BGI has been on the forefront of testing for SARS-CoV-2. Following the outbreak of the novel coronavirus in China, BGI was among the first few companies that developed the diagnostic test that received emergency approval from China’s National Medical Products Administration (NMPA) on January 26, 2020, followed by CE-IVD marking on March 2, 2020. BGI quickly scaled up manufacturing and currently has a daily capacity of up to 300,000 reactions per day. BGI has performed over 500,000 SARS-CoV-2 tests in its own central laboratories in China and is distributing its SARS-CoV-2 detection kits to more than 50 countries and regions around the world.

BGI is bringing its full genomics expertise and resources to the fight against the 2019 novel coronavirus around the world. BGI’s long history of responses to public health crisis events includes decoding the genome of the SARS virus in 2003 and developing the virus detection kit in 96 hours, and helping fight the Ebola outbreak in 2014 in West Africa, where BGI quickly set up a front-line laboratory in Sierra Leone and helped the local team to develop Ebola virus detection kits.

California Scientific Instrument Manufacturer Applied Extracts Begins Development of Novel Sterilization Technology with Potential COVID-19 Coronavirus Applications

March 17, 2020

Applied Extracts is developing a novel environmentally friendly sterilization technology with broad potential applications including mitigating the spread of the Coronavirus and other pathogens.

The company’s founder and chief engineer Dr. James White, Ph.D., stated, “Environmentally friendly sterilization technologies have the potential to improve the way medical services are delivered. We foresee broad potential applications for this technology.” The company’s technology does not rely on gamma radiation, or high heat, and could be applied to the sterilization of medical devices, garments, gloves, and masks used by first responders and medical professionals responding to the coronavirus emergency. The company’s technology could be particularly important in the event that disposable protective garments have to be re-used due to the shortages that may currently exist in the United States.

Applied Extracts was founded in 2017 by Dr. James White, Ph.D, who received his doctorate in Mechanical Engineering from the Massachusetts Institute of Technology and was formerly a Division President at Bruker BioSpin, a global scientific equipment manufacturer. Colleen Labadie White, former Associate Director of Regulatory Project Management at Beigene, Inc., is leading the company’s regulatory compliance initiative.

RELIEF THERAPEUTICS HOLDING SA Announces Plans to Test Aviptadil for Treatment of COVID-induced Acute Respiratory Distress Syndrome

March 17, 2020

RELIEF THERAPEUTICS Holding SA reports RLF-100, acquired by Relief from Mondo Biotech, AG, has Investigational New Drug clearance from the US FDA and the European Medicines Agency for phase 2 trials in ARDS and has been awarded orphan drug designation by both agencies for the treatment of ARDS, Acute Lung Injury, and Sarcoidosis.

Aviptadil is Vasoactive Intestinal Polypeptide (VIP), a naturally-occurring peptide hormone that is known to be concentrated in the lungs. VIP has been shown in five species of animal models to have a potent effect in models of ARDS and Acute Lung Injury. In these models, Aviptadil has shown potent anti-inflammatory and specifically anti-cytokine activity in the lungs.

The first clinical protocol will compare intravenous administration of Aviptadil to its administration via an endotracheal tube in patients who are already on mechanical ventilation because of ARDS. Assuming no new safety signals are detected, a second protocol will quickly be initiated to treat patients with early signs of respiratory distress in the hopes of preventing progression to ARDS and the need for mechanical ventilation.

“After carefully reviewing the preclinical and clinical data, we believe that RLF-100 has a chance to be a safe and effective treatment for Acute Respiratory Distress Syndrome in patients infected by COVID-19, who otherwise have less than 50% chance of survival, despite intensive care. The State of Israel is eager to test this potentially lifesaving treatment in patients who today have no other therapeutic option, said Dr. Halberthal. We will try every possible mechanism to help safeguard our patients in this global crisis.

“As a third-generation physician and the father of newly-trained physician, I am deeply honored to be working with longtime colleagues in Israel’s Ministry of Health on critical initiative. Owing to the rapidly expanding size of the epidemic and the extraordinary unmet medical need, we intend to initiate phase 2 clinical trials on an urgent schedule in order to bring a potentially life-saving drug to patients.”

RLF-100 (Aviptadil) is a patented formulation of Vasoactive Intestinal Polypeptide (VIP) that was originally developed and is currently marketed in Europe for the treatment of erectile dysfunction. VIP is known to be highly concentrated in the lung and to inhibit a variety of inflammatory cytokines. Aviptadil was awarded Orphan Drug Designation in 2001 by the US FDA for treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension. Aviptadil was awarded Orphan Drug Designation by the European Medicines Agency in 2006 for the treatment of Acute Lung Injury and in 2007 for the treatment of Sarcoidosis. Both the US FDA and the EMEA have granted Investigational New Drug licenses for human phase 2 trials of Aviptadil.

Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. Symptoms include shortness of breath, rapid breathing, and bluish skin coloration. Among those who survive, a decreased quality of life is relatively common.

Causes may include viral infection, sepsis, pancreatitis, trauma, pneumonia, and aspiration. The underlying mechanism involves diffuse injury to cells which form the barrier of the microscopic air sacs of the lungs, surfactant dysfunction, activation of the immune system, and dysfunction of the body’s regulation of blood clotting. In effect, ARDS impairs the lungs’ ability to exchange oxygen and carbon dioxide.

The primary treatment involves mechanical ventilation together with treatments directed at the underlying cause. The syndrome is associated with a death rate between 35 and 50%.

Free Telemedicine Solution Offered to Healthcare Providers by CompuGroup Medical

March 17, 2020

Looking for ways to slow the spread of the COVID-19 coronavirus and protect the health of practice staff and the public, medical providers are expressing an increased demand for telemedicine.

CompuGroup Medical reports CGM ELVI Telemedicine allows providers to collect patient information; share images, vitals, and findings; provide care from anywhere at any time; initiate treatments and therapies rapidly; offer continuous care to immobile patients; and reduce the workload of practice staff—all without the risk of spreading infection.

“CGM is one of the leading eHealth companies in the world,” said Benedikt Brueckle, Chief Executive Officer, CompuGroup Medical US. “We are committed to using our position to help the medical community contain the coronavirus, and that’s why we decided to offer a free, six-month subscription to CGM ELVI.”

In its community mitigation guidelines to prevent pandemic influenza, the CDC outlined the importance of flattening the curve, or reducing the number of cases and related demands on hospital and infrastructure while slowing the acceleration of the number of cases.

“The response to this program has been inspiring,” Brueckle said.

Last week, the United States enacted an emergency spending package that includes $500 million to allow Medicare providers to extend telemedicine services to seniors, regardless of where they live.

“It is our hope that the funding from Congress and our offer to provide six months of CGM ELVI electronic video conferencing at no charge will combine to greatly improve the American response to and containment of COVID-19,” Brueckle said.

Endura Embolization Device Interim Study Highlighted at Neurovascular Conference

March 17, 2020

“The Endura Embolization Device covers the aneurysm neck and provides a platform to embolize the remainder of the aneurysm sac,” said Dr. Baxter, an investor and consultant to the Company. “I am pleased to be the first to present the Endura technology to my peers. It is exciting to have this promising option on the horizon, and I believe it has the potential to significantly improve outcomes for patients with cerebral aneurysms,” added Baxter.

The Endura Embolization System consists of a detachable accessory balloon and soft platinum coils. The combination of coils and a balloon has the potential to provide immediate cerebral aneurysm occlusion, reduce the risk of coil prolapse, and promote endothelialization of the aneurysm neck by presenting a flat, solid surface at the aneurysm neck. Funded by a Phase I SBIR grant from the National Institute of Neurological Disorders and Stroke at the National Institutes of Health, the study compared the efficacy of the Endura Embolization System to coil-only treatments for the occlusion of aneurysms in a challenging model of terminal bifurcation aneurysms.

“We are pleased the Endura technology was presented at this year’s ABC-WIN conference which provided an excellent opportunity to engage with physicians,” said Dr. F. Nicholas Franano, President and CEO of Artio. “Many difficult clinical cases were presented, highlighting the challenges associated with current commercially available devices. The feedback received on the Endura System was very encouraging, and we are increasingly confident in the clinical and commercial potential of Artio’s aneurysm occlusion devices.”

Clarify Medical Appoints Linda Kotcher VP of Market Access and Reimbursement

March 17, 2020

“Linda’s extensive experience and successful track record of establishing market access for novel medical technologies will undoubtedly bolster our commercialization of the Clarify System,” said George Mahaffey, President, and CEO of Clarify Medical.

“Because the Clarify System is the only connected and monitored home NB-UVB phototherapy system on the market, we can actually demonstrate improved treatment adherence rates, thereby improving patient outcomes and potentially delaying or avoiding escalation to more expensive therapies. We are pleased to welcome Linda to the team to broaden market access for this new therapeutic option.”

“I am excited to join Clarify Medical at this important time in the company’s development,” said Ms. Kotcher. “The Clarify System is poised to enable many patients to safely and effectively treat their chronic skin conditions at home, and to drive substantial cost savings by enabling payers and providers to utilize this cost-effective therapy as recommended by the recently published Joint American Academy of Dermatology – National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy.”

The Clarify System, which has been cleared by the FDA, is indicated for localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI). It is the first and only connected phototherapy system that uses an app on the patient’s own smartphone (iOS or Android) to manage the dose, frequency, and duration of targeted narrowband UVB (NB-UVB) light therapy; the System helps to ensure that patients receive the proper doses recommended by the American Academy of Dermatology in its published Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis and The Vitiligo Working Group Recommendations for NarrowBand Ultraviolet B Light Phototherapy Treatment of Vitiligo.

The treatment regimen is prescribed by the patient’s physician but monitored and controlled by the Clarify System, enabling patients to administer precision treatment and achieve clinical efficacy with narrowband UVB phototherapy in the convenience of their homes. The connected system monitors dosing, adherence, compliance, patient progress and satisfaction.

The Clarify smartphone app syncs to a patented, lightweight, handheld device which guides patients through delivering targeted narrowband UVB phototherapy treatments for their specific skin conditions. All treatment records, including photographs and patient-reported outcomes, are available to both the patient and the physician and can be used for evaluation during follow-up visits. Clarify CarePartners, trained patient support personnel, act as the first line of support for patients – coaching them on the use of the system and encouraging treatment adherence – greatly reducing the burden of these functions on the physician’s practice.

Field-proven COVID-19 Telemedicine Solution for Hospitals

March 17, 2020

As COVID-19 continues to spread, hospitals are expecting a surge in visitors to clinics and emergency rooms, which would result in a challenging additional burden on an already overstretched medical system.

Datos’s solution, easily implemented within 48 hours, is specifically designed to support hospitals across the world to mitigate such a situation by helping to keep suspected corona patients, and those infected but not requiring hospitalization, at home while still providing them with optimal care.

Hospitals and HMOs will be able to quickly deploy a robust and scalable COVID-19 telemedicine solution tailored to provide virtual services, including online symptom-checking tools and remote consultations with doctors, while simultaneously minimizing direct contact with those infected with the coronavirus.

The Datos COVID-19-specific telemedicine package is already in use at Sheba Medical Center, Israel’s largest hospital, and has begun implementations in U.S. hospital systems.

“Datos is providing an important solution for the US health care system to monitor COVID-19 remotely, easing the demand for inpatient-based monitoring at hospitals,” said Uri Bettesh, CEO of Datos Health. “The first solution of its kind, we are able to deploy it within 48 hours. It requires no additional resources as it seamlessly integrates with care teams’ existing workflows, providing crucial insights into patients being monitored outside the hospital at a fraction of the cost. Treating patients – who do not require hospitalization – out of emergency rooms could ensure that key resources are available for the most serious cases.”

The Datos COVID-19 solution offers:

For care teams, a fully configured COVID-19 dashboard that includes an overall view of all patients sorted according to the severity of coronavirus symptoms, the delivery of daily symptom checkout surveys, the seamless launch of virtual visits via video calls (including via text message, without requiring the Datos app), data-driven reminders (to measure temperature and complete surveys), messages and content.
For patients, a user-friendly mobile app (available on iOS and Android) for home hospitalized patients to manually enter their relevant vitals, including body temperature, BP and saturation. Patients will be asked to respond to two types of coronavirus surveys, an initial assessment followed by daily symptom status updates, sent automatically and then scored and correlated with monitored vitals to yield timely reminders, personalized messages and virtual doctor visits via video calls.

The solution additionally provides health systems with a private, HIPAA compliant, cloud-based interface of the Datos platform anywhere in the world. Optional extras include services delivered via a text message with links to web pages for reporting vitals management, survey distribution and video calls.

Researchers at UC San Diego Evaluating Potential “One-Hour” COVID-19 Diagnostic Test

March 17, 2020

One Hour Covid-19 Diagnostic Test: Initial tests by Fluxergy researchers using a synthetic SARS-CoV-2 virus suggest this system has the potential to change the landscape for Point of Care (PoC) diagnostic testing for COVID-19, dramatically reducing the time it takes to get results, and delivering those results directly at the patient bedside.

Such a test, if validated by physician-scientists at UCSD, would potentially eliminate the need to send patient samples to centralized labs, significantly speeding up the time it takes to get results.

“Health providers have struggled to contain the rapid spread of COVID-19 in the U.S. and throughout the world in part because of a significant shortage of available lab tests that can quickly, efficiently and cost-effectively confirm whether patients have been infected with the virus,” said Fluxergy Co-Founder and President Tej Patel. “In bench lab testing at our research facility, utilizing a synthetic virus based on the RNA sequence made available to medical organizations, we have been able to consistently and accurately confirm in under one hour the presence or absence of SARS-CoV-2.”

Last week, the UCSD research team began an initial benchtop evaluation of the Fluxergy system using the SARS-CoV-2 virus from patients in San Diego. This evaluation is expected to be completed within one week, according to Dr. Davey Smith, Professor of Medicine and Head of the UCSD Division of Infectious Diseases and Global Public Health, who is leading the UCSD evaluation team. Dr. Smith is a member of the Fluxergy Medical Advisory Board. If the benchtop performance of the Fluxergy testing system is validated, the UCSD team plans to use the Fluxergy system to test for COVID-19 at the patient bedside at the UCSD Medical Center in accordance with FDA’s guidance while it pursues an Emergency Use Authorization (EUA).

One of the advantages of the Fluxergy system is that it is lightweight and portable – the Fluxergy Analyzer is about the size of a small desktop personal computer – which makes it applicable in a variety of clinical settings. Importantly, the Fluxergy system also does not require the SARS-Cov-2 RNA to be purified before the test can be performed. Samples are placed directly on a disposable sample-to- answer Fluxergy test card, which uses printed circuit board technology and microfluidics to automate various sample processing steps.

“Our vision is to make it possible for clinicians to quickly perform sophisticated diagnostic tests and quickly get back results right at the patient’s bedside or inaccessible urgent care settings where this information is needed the most,” said Patel.

Fluxergy is hopeful that the evaluation by UCSD physician-scientists may result in quicker identification of the presence of the SARS-CoV- 2 virus. This could potentially reduce delays that have been seen in getting back results from tests that are processed in centralized labs away from the Point of Care. If so, Fluxergy technology might thereby help mitigate the further spread of COVID-19.

The Fluxergy system is currently available as a Research Use Only (RUO), or Investigational Use Only (IUO) device for the development of new diagnostic products. The Fluxergy system has not yet been reviewed or approved by the FDA. However as noted, if the physician-scientists at UCSD obtain promising validation results using the system, they intend to begin immediate use of the diagnostic consistent with FDA’s guidance and pursue an EUA. An EUA would then enable the UCSD CLIA-certified diagnostic laboratory to continue to utilize the Fluxergy System with patients who need to be tested for the SARS-CoV-2 virus, subject to the terms and conditions set forth by FDA in the authorization.

COVID-19 is the infectious disease caused by the novel coronavirus SARS CoV-2, which was first discovered in Wuhan, China in December 2019 and now has been declared by the World Health Organization to be a pandemic. In humans, coronaviruses are known to cause respiratory infections ranging from moderate to severe symptoms; over 181,000 people in 162 countries have already been diagnosed with COVID-19, and more than 7,000 deaths have been attributed to the highly contagious viral disease as of March 16, 2020.

Other featured news items can be found here.

Radiation Shield Technologies Offers Patented Demron Apparel Providing Healthcare Workers and First Responders Unique Anti-Coronavirus Protection

March 16, 2020

“The standard gear worn by healthcare workers and first responders is ineffective at preventing transmission of the Coronavirus,” said Ronald DeMeo, M.D., CEO of Radiation Shield Technologies, the surgeon who developed the technology.

“Demron provides the highest protection that cannot be found anywhere else. With this deadly virus posing an increased risk to those caring for the afflicted as well as the general public, it is critical for healthcare workers and first responders to wear the latest gear offering the highest protection.”

Dr. DeMeo received global news attention in 2011 when he recognized that emergency responders in Japan lacked proper gear while working to contain the country’s worst nuclear crisis since 1945. His Miami-based company then donated Demron full-body nuclear radiation protection suits to protect power plant workers and rescue teams. Similarly, Dr. DeMeo is now issuing a call-to-action to help ensure American healthcare workers and first responders utilize the appropriate gear to minimize Coronavirus contamination risk.

In addition to face masks that provide the highest level of protection against disease transmission, the Demron suits have patented thermal conductive capabilities that enable health-care workers suits to be externally monitored for the onset of fever, one of the first signs of the disease.

Additionally, Coronavirus-infected patients can also be monitored and externally cooled when infection transportation chambers are lined with the Demron fabric. Ongoing testing in this area is being carried out by Dipl. Eng. Pavel Castulik, Ph.D., at the Research Centre for Toxic Compounds in the Environment, Masaryk University, Czech Republic.

Demron, manufactured solely by RST, is the world’s first and only CBRN fabric that provides chemical, biological, radiological, and nuclear protection, while also enabling external temperature monitoring.

In Africa: Jumia and Reckitt Benckiser Partner to Provide Consumers Access to Hygiene Products

March 16, 2020

The partnership will provide a steady supply of hygiene products such as soap bars, disinfectants, and liquid hand wash at affordable pricing. These products are facing growing demand from consumers taking hygiene precautions to prevent the spread of the COVID-19. Jumia will be taking 0% commission on Dettol, JIK and Harpic, and will reinvest the initial commission into discounts on the consumer price.

Reckitt Benckiser is financing free shipping nationwide on all listed products. Consumers will be able to access all products from the “Stay Safe” page on Jumia, co-owned with Reckitt Benckiser.

“At Jumia, our primary concern is the health and well-being of our teammates, consumers, partners, and communities. We strive to continue operating so that customers continue to use eCommerce as a safe way to shop in this challenging time. We are proud to work closely with Reckitt Benckiser through the “Stay Safe” campaign, which shares consistent information about COVID-19 and provides access to key hygiene products at the most affordable price possible for our consumers,” said Romain Christodoulou, SVP Jumia Group.

The partnership will also provide critical information around COVID-19. Reckitt Benckiser has created the Mythbuster website to help update consumers on risks and best practices to avoid the virus from spreading. Jumia is creating several awareness campaigns which direct consumers to both the ‘Stay Safe’ page and the ‘Mythbuster’ website.

“Reckitt Benckiser is delighted to partner with Jumia to ensure that access to the highest quality hygiene and health products is a right, not a privilege. By financing nationwide free shipping in all markets where Jumia operates, from capital cities to more rural areas, Reckitt Benckiser is providing fair access to supply for all consumers, regardless of their location,” said Bart Meermans, SVP RB Health Africa/ Middle East / Turkey.

“The Federal Competition & Consumer Protection Commission welcomes the proactive, innovative and socially responsible approach Jumia and Reckitt Benckiser have adopted in addressing potential supply shortages in key hygiene products, ensuring affordability and accessibility, and promoting awareness regarding COVID-19. FCCPC appreciates this and encourages similar dynamism that is consumer-focused and provides value to consumers and society at large. We look forward to successful outcomes from this collaboration and will provide required regulatory support that the intention for affordable access is not frustrated or exploited by any and that those who demonstrate corporate social responsibility are not at a competitive disadvantage against those who do otherwise” said Mr Babatunde Irukera, the Director-General of the Federal Competition & Consumer Protection Commission of Nigeria (FCCPC).

The partnership will cover 8 of the markets where Jumia operates, Algeria, Egypt, Ghana, Kenya, Morocco, Nigeria, South Africa, and Uganda.

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Applied Extracts is developing a novel environmentally friendly sterilization technology with broad potential applications including mitigating the spread of the Coronavirus and other pathogens.

Looking for ways to slow the spread of the COVID-19 coronavirus and protect the health of practice staff and the public, medical providers are expressing an increased demand for telemedicine.

As COVID-19 continues to spread, hospitals are expecting a surge in visitors to clinics and emergency rooms, which would result in a challenging additional burden on an already overstretched medical system.

“The standard gear worn by healthcare workers and first responders is ineffective at preventing transmission of the Coronavirus,” said Ronald DeMeo, M.D., CEO of Radiation Shield Technologies, the surgeon who developed the technology.

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