A New Surge in Cases Emphasizes the Need for Effective Diagnostics

NEW YORK, Dec. 2, 2020 /PRNewswire/ -- As of earlier this week, the U.S. has reported more than 13.6 million cases and over 269,348 deaths, according to Johns Hopkins University. Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases, has also warned of "two to three thousand deaths a day times a couple of months, and you're approaching a really stunning number of deaths," USA Today reported. Because of the projected increase in the number of infected, states and cities are now planning new proposals and restrictions for the winter. For example, New York Governor Andrew Cuomo announced his winter plan this Monday in case of another surge. The plan includes managing hospital capacity, adding beds, and identifying retired staff who can come back to work. In addition, New York City Mayor, Bill de Blasio, has explained, according to ABC 7, that "it's a call to arms. We need to make sure we never end up in a situation like we did in the spring and so much of that depends on individual behavior and really respecting the fact that we have to avoid any kind of large indoor gatherings," the Mayor said. "We have to ensure that people wear those masks, indoors and outdoors. These are the things that make a difference." Todos Medical Ltd. (OTC: TOMDF), Co-Diagnostics, Inc. (NASDAQ: CODX), OPKO Health company (NASDAQ: OPK), Novavax, Inc. (NASDAQ: NVAX), Pfizer Inc. (NYSE: PFE)

There is hope, however, as major pharmaceutical companies are now very close to an effective vaccine to fight the current pandemic. Earlier this month, Pfizer and BioNTech SE announced that they will submit a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2. The submission is based on a vaccine efficacy rate of 95%, demonstrated in the Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. Yet, it is still unclear when the vaccine will be available to the public. In the meantime, testing remains a crucial factor in the fight against the pandemic.

Todos Medical Ltd. (OTCQB: TOMDF) reported yesterday breaking news regarding, "a corporate update to the market, as well as an outlook for the Company as it heads into 2021.

COVID-19 Testing Sets the stage for the future

Todos recently completed the installation of two (2) Tecan® liquid handlers at its largest lab client in Wisconsin, thereby providing the lab liquid handlers in addition to automated extraction systems. After optimizing the workflows following the installation, we are confident this lab will be able to process up to 20,000 qPCR tests per day, with the lab now operating 24 hours per day, seven (7) days a week. This PCR testing capacity positions the lab to be able to increase sample inflows from its contract with the State of Wisconsin by up to 450%, which in turn will significantly increase order flow for Todos' PCR testing consumables.

Additionally, we are preparing to complete the installation of a similar lab automation workflow process at another lab in Brooklyn, NY in the month of December, which will bring that lab's testing capacity to 20,000 PCR tests per day. Taken together, we are demonstrating Todos' ability to provide lab clients with automated workflows that can achieve high-throughput PCR testing capacity, coupled with the fact that this is a repeatable model that can significantly drive revenue. We intend to strategically scale existing clients and bring on new clients that have developed solid contracts for sample processing that will allow them to order large volumes of tests per day, leading to increased PCR sales for Todos.

As PCR testing continues to grow, recent advances in vaccine development will drive immune testing to understand whether immunity has been attained in individuals, either by prior COVID-19 infection or COVID-19 vaccination. Todos has established relationships with leading companies developing next-generation immune-based blood testing, and we intend to add these tests to our offering as they gain regulatory approval. Additionally, our proprietary 3CL protease test is in the final stages of testing before launch of lab-based test that will be complementary to existing PCR testing by confirming the activity status of the virus-positive patients. This assay will give better understanding of whether a patient remains contagious following quarantine or therapeutic intervention, and whether the Company's proprietary dietary supplement Tollovid® could have an impact on the length of time a person remains infected. A clinical trial for Tollovid is being prepared in Israel.

Our business model is now set on offering genetic and immune testing reagents & kits to our clients, as the genetic testing capabilities labs are acquiring now in response to the COVID-19 crisis will allow them to expand their offerings to make available more cost-effective, scalable, genetic and immunology testing solutions to the market in the future. We believe this could drive the next wave of innovation in the US laboratory industry and give rise to better health information that will empower patients and physicians to make better decisions that will improve outcomes and reduce costs. The infrastructure required to turn the promise of personalized medicine into a reality is largely being pushed forward in response to COVID-19, and we see this as a megatrend that will continue well into the future.

We believe the mobile testing labs we have been helping advance have a similar opportunity to improve the landscape for testing in the United States by creating a proprietary outlet for novel testing solutions that will further support the nation's testing infrastructure. Bringing testing forward in a new, more personalized way that reduces wait times and is agile enough to be deployed anywhere will survive the pandemic and will ultimately provide another key distribution channel for our testing solutions.

Todos' Breast Cancer testing will become more central in 2021

2020 forced Todos to establish its commercial testing operations initially focused on COVID-19. As we head into a long winter where we expect cases to spike to record levels before vaccination programs can hopefully help reduce the severity of the pandemic, we are also beginning to think about the post-pandemic future and how Todos can establish itself as an important player in the diagnostic testing business for the long-term. As such, we are focused on utilizing the opportunity provided by COVID-19 testing to position for launch of diagnostic testing through the commercial outlets we are establishing now.

We intend to focus our pipeline initially on breast cancer where we are building up significant intellectual property around our proprietary TBIA/FTIR platform, and commercial infrastructure by way of the strategic acquisition of Provista Diagnostics, so that we can consolidate our commercial opportunity and optimize assay performance as we go to market in 2021 in breast cancer blood testing…"

For our latest "Buzz on the Street" Show featuring Todos Medical Ltd. recent corporate news, please head over to: https://www.youtube.com/watch?v=LBoSYVt620w

Co-Diagnostics, Inc. (NASDAQ: CODX) announced last month that CoSara Diagnostics Pvt Ltd ("CoSara," or the "JV"), its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization ("CDSCO") in India to manufacture and sell its Saragene™ COVID-19 2-gene multiplex RT-PCR test as an in vitro diagnostic ("IVD"), intended for the qualitative detection of the SARS-CoV-2 virus. The Saragene test kit approved by the CDSCO uses the Company's patented CoPrimer™ technology and is based on a test originally designed by Co-Diagnostics, who also recently announced receipt of a CE marking for its Logix Smart™ SARS-CoV-2 (genes RdRp/E) multiplex test. Both the CoSara and Co-Diagnostics test target two gene markers of the SARS-CoV-2 genome, RdRp and E-gene, to identify the presence of the virus, and were designed to meet the needs of those markets where government or regulatory bodies recommend a multi-target coronavirus diagnostic.

OPKO Health company (NASDAQ: OPK) announced back in October 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.

Novavax, Inc. (NASDAQ: NVAX) provided an update this week on its COVID-19 vaccine program. NVX–CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax' proprietary Matrix–M™. "Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide."

Pfizer Inc. (NYSE: PFE) announced last month that it will submit a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020. The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies' Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose.

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