The Need for Precise Testing Capabilities is Clear as Cases Surge

NEW YORK, Nov. 19, 2020 /PRNewswire/ -- Recent reports from across the country clearly show that infection cases are once again surging. More than 11.4 million Americans have now been infected with the virus and the number of deaths has surpassed 248,000. In fact, the average number of new daily cases in the United States is at a record, as mortality rates are also catching up. At least 1,707 new deaths were reported Tuesday, according to data from Johns Hopkins University. That's the highest daily death toll since May 14th. This, in turn, puts pressure on local hospital systems, forcing new curfews and other restrictions in parts across the country. Dr. Jonathan Reiner, a professor at George Washington University School of Medicine, explained according to CNN that "the horrible death count that we saw yesterday in the United States ... reflects the number of people who were being infected three weeks ago -- two to three weeks ago, because that's the lag... On average, two to three weeks ago, we were seeing 70,000 to 80,000 (new) cases per day. Yesterday, there were about 155,000 (new) cases. So if you're alarmed at the 1,700 deaths today, two to three weeks from now, we're going to see 3,000 deaths a day." Todos Medical Ltd. (OTC: TOMDF), OPKO Health company (NASDAQ: OPK), Chembio Diagnostics, Inc. (NASDAQ: CEMI), Co-Diagnostics, Inc. (NASDAQ: CODX), Vir Biotechnology, Inc. (NASDAQ: VIR)

Mass testing is crucial for governments to properly implement preventive measures throughout this pandemic. While the U.S. is testing more people than ever, according to data compiled by the Covid Tracking Project, more testing cannot be an explanation for the rise in cases because the percent of tests coming back positive has increased as well, Health officials explained. And until recently, at-home tests were not possible. However, this week, the FDA finally approved the first diagnostic at-home self-test that provides rapid results. FDA Commissioner Stephen Hahn said, "This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission."

Todos Medical Ltd. (OTCQB: TOMDF) announced yesterday breaking news regarding, "positive clinical proof of concept data from its lab-based rapid SARS-CoV-2 3CL protease diagnostic assay in collaboration with its COVID Antigen Test Killer LLC joint venture partner NLC Pharma. The data generated by NLC Pharma in Israel produced 100% sensitivity and 100% specificity in PCR-confirmed positive and negative COVID-19 patient samples. The team is now gathering additional clinical data to submit an emergency use authorization (EUA) to the United States Food & Drug Administration ( FDA) for its lab-based test to be distributed through Todos' existing lab distribution channels. Todos is evaluating the best option for the commercialization of its rapid point-of-care version of the 3CL protease assay for the screening and diagnosis of symptomatic and asymptomatic COVID-19 carriers, based on recent updated guidance from the FDA for COVID-19 diagnostic point of care tests.

'The 3CL protease is proving to be an exciting reliable, cost effective and rapid alternative to RNA analysis for detecting SARS-CoV-2,' said Dr. Dorit Arad, PhD, Chief Scientific Officer of NLC Pharma. 'We base our technology on sound science, and our assay concept - to detect only the live enzyme activity - has advantages over rapid antigen testing that can include high rates of false positives and false negatives. Our rapid test, on the other hand, is based on detecting 3CL protease activity which is present only at the stage when the virus is actively replicating. Thus, an active protease indicates the presence of a live and replicating virus. Our technology is ideally suited for the high sensitivity detection of individuals infected with replicating virus, regardless of symptom status.'

'Just last week we saw Elon Musk take issue with the lack of consistency with antigen testing, and we wholeheartedly understand his concern,' said Jorge Leon, PhD, Chief Medical & Scientific Officer of Todos Medical. 'We believe that our rapid testing 3CL technology will successfully pair with the antigen testing distribution networks being established to bring the point-of-care version of our 3CL assay into the market for widespread uptake as the long-term solution for rapid point of care COVID testing. In the meantime, we will deploy our clinical lab-based 3CL assay together with our existing PCR testing distribution networks to confirm that positive PCR tests are, in fact, picking up actively replicating virus versus inactive viral remnants that can sometimes show false positive RT-PCR results, keeping the person in quarantine needlessly. This would be quite an important addition to the current emerging COVID-19 testing paradigm.'

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OPKO Health company (NASDAQ: OPK) announced last month the beginning of its COVID-19 testing program for New York City schools throughout the 2020-2021 school year to help ensure a safer school environment. Continuing a strategic collaboration with New York City, the Department of Health, New York City Health and Hospital Corporation (NYC Health + Hospitals), the Test & Trace Corp, and the Department of Education, BioReference is performing COVID-19 molecular testing for NYC schools. In addition, BioReference is collecting specimens from principals, teachers, administration and students from over 950 schools across NYC. "This school year for New York City and other school systems around the world is vastly different due to the global pandemic, and BioReference is privileged to aid in keeping NYC schools safe," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories.

Chembio Diagnostics, Inc. (NASDAQ: CEMI) announced last week that its subsidiary Chembio Diagnostics Brazil Ltda. has received regulatory approval from Agência Nacional de Vigilância Sanitária (ANVISA) to market the DPP SARS-CoV-2 Antigen test system in Brazil. The DPP SARS-CoV-2 Antigen test system is designed to detect SARS-CoV-2 antigens in only 20 minutes. The detection of specific SARS-CoV-2 viral antigens implies a current infection by the virus responsible for COVID-19 cases. The DPP SARS-CoV-2 Antigen test system consists of a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader 1 or DPP Micro Reader 2 analyzer, and a minimally invasive nasal swab. Clinical trial data demonstrates sensitivity of 96.0% at zero to six days from the onset of symptoms and specificity of 98.7% on symptomatic population as compared to PCR tests.

Co-Diagnostics, Inc. (NASDAQ: CODX) announced on October 2nd that Access Genetics, LLC dba OralDNA® Labs, a CLIA-certified customer who uses the Company's Logix Smart(TM) COVID-19 kit in their FDA authorized OraRisk® COVID-19 RT-PCR test, recently received an amended Emergency Use Authorization (EUA) allowing testing from a saline oral rinse collection. Dwight Egan, CEO of Co-Diagnostics, remarked "We are pleased that Co-Diagnostics technology is being used in the first FDA EUA for a test using a simple saline 30 second swish and gargle collection. Because it eliminates the need for a nasal swab, oral rinse technology has the potential to dramatically improve comfort and accessibility of testing in our communities and we believe this authorization by the FDA provides additional confirmation of the quality, versatility, and adaptability of our CoPrimer(TM) platform."

Vir Biotechnology, Inc. (NASDAQ: VIR) and GlaxoSmithKline plc announced earlier last month the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study evaluating VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization. VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (one of the major sites of infection). Following a positive assessment of unblinded safety data from the lead-in portion of the trial by an Independent Data Monitoring Committee on September 30, 2020, the COMET-ICE registrational study will now expand globally to additional sites in North America, South America and Europe.

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