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.
About Todos Medical Ltd.
Founded in Rehovot, Israel with offices in New York City, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos' two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe. Todos recently acquired U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing and Provista's proprietary commercial-stage Videssa® breast cancer blood test.
Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.
Todos has entered into distribution agreements with companies to distribute certain (COVID-19) testing materials and supplies. The agreements cover multiple suppliers of PCR testing kits, extraction kits, automation materials and supplies, as well as COVID-19 antibody and antigen testing kits.
Todos has entered into a joint venture with NLC Pharma to pursue the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target a fundamental reproductive mechanism of coronaviruses.
For more information, please visit https://www.todosmedical.com/.
Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.
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Released August 23, 2021