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Todos Medical Announces Addition of Semi-Quantitative Titer Claims to the Emergency Use Authorization for the cPass Neutralizing Antibody Test
Todos Medical Announces Addition of Semi-Quantitative Titer Claims to the Emergency Use Authorization for the cPass Neutralizing Antibody Test.
About this update from Todos Medical Ltd.
[{"type":"text","content":"\n ·       Reauthorization of EUA expands beyond initial qualitative detection claim ·       CEO to appear on Cheddar News at 6:10pm tonight, November 17th, 2021 New York, NY, and Tel Aviv, ISRAEL, Nov. 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 reauthorized the 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 to SARS-CoV-2 in human serum and dipotassium EDTA plasma. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Concurrent with this announcement, the Company announced that CEO Gerald Commissiong is to appear on Cheddar News at 6:10pm tonight, November 17th, 2021. For more information, please visit www.todosmedical.com. For more information on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com. * This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the presence of total neutralizing antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 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 an...