Point of Care Diagnostics Ease the Strain on Traditional Healthcare Systems

- FinancialBuzz.com News Commentary

NEW YORK, Oct. 28, 2020 /PRNewswire/ -- As cases of infection continue to rise nationwide, California has become the latest addition to the New York quarantine list Tuesday, bringing the total number of affected U.S. states and territories to 41. According to Communications Officer World Health Organization (WHO), the pandemic has led to a dramatic loss of human life worldwide and presents an unprecedented challenge to public health, food systems and the world of work. The economic and social disruption caused by the pandemic is devastating: tens of millions of people are at risk of falling into extreme poverty, while the number of undernourished people, currently estimated at nearly 690 Million, could increase by up to 132 Million by the end of the year. Among the WHO's recommendation to mitigate the impact of the pandemic are to maintain essential health services with sufficient funding, supplies, and human resources as well as to enhance capacity for public health surveillance, testing, and contact tracing. Todos Medical Ltd. (OTC: TOMDF), AstraZeneca Plc (NYSE: AZN), Vir Biotechnology, Inc. (NASDAQ: VIR), Co-Diagnostics, Inc. (NASDAQ: CODX), FLIR Systems, Inc. (NASDAQ: FLIR)

Because of the demand for more testing capabilities and contact tracing, new innovations have been introduced into the field in recent months. The National Institutes of Health (NIH), working in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), announced earlier this month a third round of contract awards for scale-up and manufacturing of new testing technologies for the current pandemic. The six new Rapid Acceleration of Diagnostics (RADx) initiative contracts total USD 98.35 Million for point-of-care and other novel test approaches that provide new modes of sample collection, processing and return of results. 

Todos Medical Ltd. (OTCQB: TOMDF) announced earlier this week breaking news regarding, "the completion of the instrument validation in its mobile lab division. The Company's mobile CLIA lab partner, Integrated Health, has fully validated the analytical performance of the Company's proprietary ANDis 350 RNA auto-extraction machine in combination with its Accurate 96 qPCR machine as part of the COVID-19 RT-PCR laboratory testing validation process being performed in MOTO+PARA's Mobile High Complexity Lab. Integrated Health expects to complete the clinical validation needed to support the commercial launch in mid-November. MOTO+PARA is in talks with several entities and expects to begin accepting contracts in mid-November 2020.

'We have spent the last 3 months building the mobile labs system in preparation for a commercial launch with a focus on the highest quality, consistent data generation, and overcoming the many technical challenges that presented themselves in the creation of a highly scalable Biosafety Level 3 built mobile lab,' said Eric Canonico, CEO of MOTOPARA Foundation. 'We are pleased to have these high levels of analytical performance in the Todos instruments.'

'We feel extremely comfortable working with these instruments given the quality and consistency of the data we can now generate after spending the last 8 weeks in validation,' said Brandon Albin, Managing Partner at Integrated Health. 'We are confident we can commercially launch the COVID-19 qPCR assay using Todos' testing paradigm and reach capacity of 1000 PCR tests per day per mobile unit, in addition to antigen and antibody testing.'

'We are very excited about the potential of the mobile labs project to increase the availability and quality of testing in the United States and abroad,' said Gerald Commissiong, President & CEO of Todos Medical. "Having the ability to reduce PCR turnaround times from 3-6 days to potentially as little as 3-6 hours is a complete game changer in terms of speed to diagnosis and reducing time to isolation, which would dramatically reduce the potential for a patient to become a close contact to others, as defined by the Centers for Disease Control. We will also be offering COVID-19 antigen screening and surveillance testing, as well as antibody testing to our laboratory and delivery of care partners.

Currently, Integrated Health is in the process of testing 30 known positive and 30 known negative samples to receive CLIA certification allowing MOTO+PARA High Complexity Mobile Labs to operate under Integrated Health's U.S. national mobile CLIA lab license, authorized in all 50 states in the U.S. The companies expect to reach this milestone in mid-November.

For information related to Todos Medical's COVID-19 testing capabilities, please visit www.todoscovid19.com

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AstraZeneca Plc (NYSE: AZN) concluded on August 14th, an agreement with the European Commission (EC) to supply up to 400 million doses of the AZD1222 COVID-19 vaccine. Building on the existing agreement with Europe's Inclusive Vaccines Alliance spearheaded by Germany, France, Italy and the Netherlands, this new agreement will give all EU member states the option to access the vaccine in an equitable manner at no profit during the pandemic. It also allows EU member states to redirect doses to other European countries.  Pascal Soriot, Chief Executive Officer, said: "This first vaccine agreement with the European Commission will ensure that millions of Europeans have access to the AZD1222 vaccine following its approval. With production in our European supply chain soon to be started, we hope to make the vaccine available widely and rapidly, with the first doses to be delivered by the end of 2020. I would like to thank the entire European Commission, and especially the Commissioner for Health and Food Safety, Stella Kyriakides, for their swift response in ensuring Europeans may soon be protected with a vaccine against this deadly virus, enabling our global society and economy to rebuild."

Vir Biotechnology, Inc. (NASDAQ: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) announced earlier this 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.

Co-Diagnostics, Inc. (NASDAQ: CODX) announced back in September that its Logix Smart™ ABC Test (Influenza A/Influenza B/COVID-19) is anticipated to be ready for launch to US CLIA laboratory customers the first week of October 2020. "Co-Diagnostics is committed to participating in the fight against COVID-19 through the development and manufacture of vital diagnostic testing solutions, with none perhaps as important as this upcoming ABC multiplex test," remarked Dwight Egan, CEO of Co-Diagnostics. "Our patented CoPrimer™ technology platform is ideally suited for multiplex reactions by substantially reducing 'primer-dimers,' a phenomenon in PCR molecular tests that results in false positive results. At a time when the need for accurate detection of COVID-19 as well as the differentiation between strains of the flu has never been greater, we are pleased to be able to contribute to the safety and well-being of communities across the country and around the world."

FLIR Systems, Inc. (NASDAQ: FLIR) announced earlier in June the FLIR Screen-ESTTM software for FLIR T-Series, Exx-Series, and A-Series thermal imaging cameras. The software provides automatic measurement tools that perform elevated skin temperature screenings of individuals in two seconds or less at entries, checkpoints, and other high-traffic areas while maintaining recommended social distancing guidelines. "Governments and businesses across the globe are hard at work developing new processes to ensure public health and safety from COVID-19, including the use of radiometric thermal imaging cameras as part of a comprehensive frontline screening program," said Jim Cannon, President and CEO at FLIR. "Now with FLIR Screen-EST software, those organizations can increase the speed and accuracy of frontline screening when using FLIR's thermal cameras."

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