Todos Medical Announces New cPass Neutralizing Antibody Testing Reference Lab Agreement for CLIA/CAP Lab Provista with Physician Group in 40 States
§ Provista completed validation for fingerprick At-Home sample collection of blood for the cPass neutralizing antibody test
New York, NY, and Tel Aviv, ISRAEL - (NewMediaWire) - December 22, 2021 - Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its highly automated CLIA/CAP PCR and cPass neutralizing antibody COVID-19 testing laboratory Provista Diagnostics has entered into a reference laboratory services agreement with a Kentucky-based physician group with practices in over 40 states that focuses on blending the benefits of old fashioned medicine and modern healthcare, with a goal of providing “concierge for everyone” (the “Physicians Group”). This reference lab agreement covers the semi-quantitative cPass neutralizing antibody test that recently expanded upon its Emergency Use Authorization with the addition of semi-quantitative titer claims to be able to measure convalescent neutralization activity and provide a score to monitor over time.
In addition, Provista has completed the validation for a fingerprick At-Home sample collection device for the cPass neutralizing antibody test. The Company expects to launch a direct-to-consumer self-collection At-Home cPass neutralizing antibody test to enable people to monitor titers from the comfort of their own homes in the very near future.
“We are very pleased to be winning laboratory service contracts for Provista with cPass because we see the value of this test, especially in light of the highly contagious Omicron variant that demands much higher titers of neutralizing antibodies to achieve neutralization activity,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Given waning immunity with existing vaccines that require boosters to be taken timely, or risk susceptibility to infection with Omicron, we expect to continue to gain in popularity as we move forward. With the addition of fingerprick At-Home cPass testing, we can make it very convenient to help patients test and monitor their neutralizing antibody titers which we believe should substantially increase the market opportunity for this important test.”
For more information on Provista’s parent company Todos Medical, please visit www.todosmedical.com. For more information on Provista Diagnostics’ CLIA/CAP certified lab please visit www.provistadx.com.
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. In 2021, Todos completed the acquisition of 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. 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 is focused on the commercialization of Videssa and will bring the TBIA tests to market thereafter.
Todos has entered into a joint venture with NLC Pharma targeting diagnostic and testing solutions to address the COVID-19 pandemic. The Joint Venture is pursuing the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target a fundamental reproductive mechanism of coronaviruses. The Company’s proprietary therapeutic candidate Tollovir™ is currently in a Phase 2 clinical trial to treat hospitalized COVID-19 patients in Israel, and is preparing to initiate Phase 2/3 clinical trials for both hospitalized and non-hospitalized patients in Israel.
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 is also distributing certain (COVID-19) testing materials and supplies to CLIA-certified labs in the United States. The products cover multiple suppliers of PCR testing kits, extraction kits, automation materials and supplies, as well as COVID-19 antibody and antigen testing kits.
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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