Â· EUA reauthorization extends beyond initial qualitative detection request
Â· CEO to appear on Cheddar News at 6:10 p.m. tonight, November 17, 2021
New York, NY, and Tel Aviv, ISRAELL, November 17, 2021 (GLOBE NEWSWIRE) – via NewMediaWire – Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that the United States Food & Drug Administration has re-authorized Emergency Use Authorization (EUA) for the cPass neutralizing antibody test ( “CPass”) *. The new indication for cPass now reads:
Qualitative and semi-quantitative direct detection of total neutralizing antibodies against SARS-CoV-2 in human serum and dipotassium EDTA plasma. For use in helping identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or past infection. Emergency use of this test is limited to authorized laboratories.
Along with the announcement, the company announced that CEO Gerald Commissiong will appear on Cheddar News at 6:10 p.m. tonight, November 17, 2021.
* This test has not been authorized or approved by the FDA. This test has been cleared by the FDA under an EUA for use by authorized laboratories. This test has only been authorized for the presence of total neutralizing antibodies against SARS-CoV-2, not for other viruses or pathogens. This test is only authorized for the duration of the declaration that there are circumstances justifying the authorization of the emergency use of in vitro diagnostics for the detection and / or diagnosis of COVID-19 under the Federal Food, Drug and Cosmetic Act, Section 564 (b) (1), 21 USC Â§ 360bbb-3 (b) (1), unless the authorization is terminated or revoked earlier.
About Todos Medical Ltd.
Founded in Rehovot, Israel, with offices in New York, Todos Medical Ltd. (OTCQB: TOMDF) designs vital diagnostic solutions for the early detection of a variety of cancers. The company’s state-of-the-art, patented Todos Biochemical Infrared Analyzes (TBIA) is a proprietary cancer screening technology using peripheral blood analysis that deploys a comprehensive examination of the influence of cancer on the immune system, at the search for biochemical changes in mononuclear cells in blood and plasma. The two cancer screening tests developed in-house by Todos, TMB-1 and TMB-2, have received CE marking in Europe. Todos recently acquired the U.S. medical diagnostics company Provista Diagnostics, Inc. to secure the rights to its CLIA / CAP certified lab based in Alpharetta, Georgia, which currently performs COVID PCR testing and the VidessaÂ® breast cancer blood test. from Provista to the commercial stage.
Todos is also developing blood tests for the early detection of neurodegenerative diseases, such as Alzheimer’s disease. The Lymphocyte Proliferation Test (LymPro Test â¢) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBL) and monocytes to resist 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 reentry of the cell cycle 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 made distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover several international suppliers of PCR test kits and related equipment and supplies, as well as antibody test kits from several manufacturers after completing validation of said test kits and supplies at its CLIA / CAP certified partner laboratory in United States. Additionally, Todos has entered into a joint venture with NLC Pharma to further develop diagnostic assays targeting 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 clinical development programs and expected clinical trials. These forward-looking statements are based solely on management’s current expectations, 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 risks and uncertainties associated with 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 secure the 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 forward-looking statements: changes in technology and market requirements; delays or obstacles in starting our clinical trials; changes in legislation; the inability to develop and introduce new technologies, products and applications in a timely manner; the lack of validation of our technology as we progress and the lack of acceptance of our methods by the scientific community; failure 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; a higher cost of the final product than expected; loss of market share and price pressure resulting from competition; and laboratory results which do not translate into equally good results under actual conditions, which could cause actual results or performance to differ materially from those contemplated in such forward-looking statements. Unless otherwise provided by law, Todos Medical assumes no obligation to publish revisions of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unforeseen 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 United States Securities and Exchange Commission.
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