Todos Medical Completes Validation of cPass Neutralizing

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Todos Medical Completes Validation of cPass Neutralizing Antibody Blood Test at Provista Diagnostics to Quantify and Monitor Key Biomarkers of COVID-19 Immunity

 Company sees a significant market opportunity for cPass as a potential immunity monitoring tool for schools, businesses and healthcare providers to determine the future need for booster shots or other measures to prevent virus spread CEO to discuss cPass on Fox Business Network ‘Varney & Company’ at 11:40 am on August 23, 2021 Validation paves the way for launch of cPass testing at Provista in September 2021

New York, NY, and Tel Aviv, ISRAEL, Aug. 23, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP certified lab Provista Diagnostics has successfully completed the validation studies required to put the cPass Neutralizing Antibody Blood Test into production and expects to launch cPass in September 2021. The cPass ELISA blood test has received Emergency Use Authorization from the FDA for the detection of neutralizing antibodies (NAbs) that will allow healthcare professionals and patients to monitor key biomarkers of COVID-19 immunity.

Todos Medical CEO Gerald Commissiong has been scheduled to appear on Fox Business Network show Varney & Company at 11:40 am ET on Monday, August 23, 2021 to discuss cPass and how it is expected to empower healthcare professionals and patients with a new tool to monitor their immunity to COVID-19 as booster shots are being rolled out in the United States.  There are a rising number of breakthrough infections and the cPass may represent a way to identify those at greatest risk.

“As we begin to see the impact of breakthrough infections with the Delta variant throughout the United States, we expect the FDA to authorize widespread access to booster shots in the weeks ahead,” said Gerald Commissiong, President & CEO of Todos Medical. “Vaccinated and unvaccinated patients are certainly looking for solutions to understand their level of risk to the Delta variant.  Likewise, many physicians are looking for objective data to help them manage their patients. cPass will help provide this key information on neutralizing antibody levels in vaccinated patients and patients that acquired their immunity through natural infection.  The test allows both the patient and the physician to be more informed with respect to the patient’s existing level of COVID-19 immunity.  The White House push to get people vaccinated quickly in the second quarter displaced the testing volume that was expected by many COVID testing labs and so they retooled back to their pre-pandemic business models centered on non-COVID sample volume. We chose a different path for Provista and sought to invest in automation to prepare for the next wave of the disease and the tremendous monitoring opportunity we felt it represented.  We saw our local community in the greater Atlanta area ravaged by the first and second waves of the disease due to a lack of testing capability, and felt we had an obligation to be more proactive to fulfill the market need just as schools and business prepare to open for the fall.  We think cPass could play a pivotal role in helping roll out booster shots to those at-risk in the months ahead.

Todos sees a large market opportunity developing for cPass that will expand upon the COVID-19 PCR testing market that rapidly developed into an $80 billion market worldwide in 2020.  Provista Diagnostics has the automation in place to do up to 20,000 PCR tests and over 1,500 cPass tests per day.  The CMS reimbursement rate per PCR test is $100 and per cPass test is at least $79.  Immune monitoring will likely be the primary driver of COVID-19 testing growth going forward.  To date, over 200 million people in the United States have received at least one COVID-19 vaccine dose, with the majority of the doses having been administered to older populations and the immunocompromised for whom booster shots are being recommended. As time advances, and more and more individuals are 6 months and beyond from their initial vaccine dose, it will become increasingly important for individuals, schools, businesses and healthcare providers to asses and monitor neutralizing antibody levels in order to make data-driven decisions with respect to booster shots and behavioral changes.
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