§ cPass neutralizing antibody testing seeing increasing demand, questions of infection-acquired immunity, vaccine-acquired immunity and booster shot durability emerge
§ The Company also entered into a new laboratory services agreement with a New Jersey-based physician practice for COVID PCR testing and cPass neutralizing antibody testing
New York, NY, and Tel Aviv, ISRAEL – (NewMediaWire) – December 27, 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 achieved consecutive record weekly COVID PCR testing volumes for the weeks of December 13, 2021 and December 20, 2021. The COVID PCR testing volumes were primarily driven by reference lab business from a New York-based PCR testing lab that could not fulfill the testing demand from its location. The Company also entered into a new laboratory services agreement with a New Jersey-based physician practice for COVID PCR Testing and COVID cPass neutralizing antibody testing.
“The demand for PCR testing is rapidly increasing in pockets of the United States, and we expect this to continue beyond the holiday surge as individuals, schools and employers seek to create safe environments, especially in areas with low vaccination rates,” said Gerald E. Commissiong, President & CEO of Todos Medical, the parent company of Provista Diagnostics. “Given the pending ‘vaccine or test’ mandate from the Biden Administration that will impose testing requirements on the 38% of the US adult population that have yet to be fully vaccinated against COVID-19, we see the recent scarcity of testing combined with the pending mandate creating demand for a very significant increase in long-term institutional COVID PCR testing for Provista. When you add the Omicron variant’s ability to evade vaccine or infection-acquired immunity, and the challenges of access and reliability of rapid antigen tests that notoriously yield false negative results, COVID PCR testing with fast turnaround times is emerging as the most trusted and reliable source of information to know one’s COVID infection status.”
Mr. Commissiong continued, “Further, when you combine these realities with a recent uptick in interest in boosters to buttress vaccine or infection-acquired immunity against Omicron, we are beginning to see a marked increase in interest for the cPass neutralizing antibody test to monitor levels of circulating neutralizing antibody testing and allow patients to make rapid, data-driven decisions to get their booster shots, especially given emerging data that suggests high neutralizing antibody-titers produced from a recent booster shot is the most likely to protect an individual against Omicron infection.”
Recent data emerging from Israel suggests neutralizing antibody titers in response to the Pfizer/BioNTech Comirnaty vaccine begins to wane after 4 months from full-vaccination, and that booster shots of Comirnaty begin to wane after 10 weeks from the booster shot. A fourth shot (the “Second Booster”) was recently authorized in Israel for the immune-compromised and those 60+, and a study is underway to determine the durability of a Second Booster for the general population.
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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