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New York, NY, and Tel Aviv, ISRAEL, Oct. 14, 2022 (GLOBE NEWSWIRE) — via NewMediaWire —Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP-certified clinical laboratory Provista Diagnostics has filed for Emergency Use Authorization (EUA) with the Food & Drug Administration ( FDA) of the United States for its MonkeyPox PCR test. EUA request has been submitted for lesion-based PCR. The sensitivity achieved for the currently available lesion-based laboratory-developed test (LDT) is 0.95 viral copies per reaction (0.095 copies/µl).
“The submission of this EUA request underscores our commitment to providing the best PCR-based tests for emerging infectious diseases,” said Gerald E. Commissiong, President and CEO of Todos Medical and Provista. “Regulatory changes at the FDA have forced us to only be able to offer lesion-based PCR testing. As we conduct more research and work with the agency, we hope to be able to submit an EUA for saliva-based PCR testing for MonkeyPox in the future.
About Todos Medical Ltd.Founded in Rehovot, Israel, with offices in New York, Todos Medical Ltd. (OTCQB: TOMDF) designs life-saving diagnostic solutions for the early detection of various cancers. The company’s advanced and patented technology Infrared Biochemical Analyzes (TBIA) is a proprietary cancer screening technology using peripheral blood analysis that examines the influence of cancer on the immune system, looking for biochemical changes in blood mononuclear cells 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 a US-based medical diagnostics company Provista DiagnosisInc. to obtain the rights to its CLIA/CAP-certified laboratory based in Alpharetta, Georgia, which currently performs COVID PCR testing, Long COVID sectionl Provista’s exclusive Videssa® breast cancer screening blood test and analyzes at the commercial stage. More information about Provista is available at www.provisadx.com.
Todos also develops 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 (PBL) and monocytes to resist exogenous mitogenic stimulation that prompts them to enter the cell cycle. Some diseases, including Alzheimer’s disease, are thought to be the result of compromised cellular machinery that leads to aberrant cell cycle reentry by neurons, which then leads to apoptosis. LymPro is unique in using peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and brain neurons.
Todos formed the majority-owned Israel-based joint venture 3CL Pharma, Ltd with NLC Pharma in March 2022 to consolidate all intellectual property surrounding 3CL protease-based diagnostic tests and the development of botanical and pharmaceutical 3CL protease inhibitors that target a fundamental reproductive system. coronavirus mechanism. 3CL Pharma, through the Todos brand, has commercialized the 3CL Tollovid™ protease inhibitor immune support dietary supplement in the United States, is developing the dual mechanism 3CL protease inhibitor and anti-cytokine therapeutic drug candidate Tollovir™, while also developing the 3CL protease diagnostic TolloTest™.
Forward-looking statementsCertain 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 solely on the current expectations of management and are subject to important risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including risks and uncertainties relating 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 financing 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 the initiation of our clinical trials; changes in legislation; failure to develop and introduce new technologies, products and applications on a timely basis; lack of validation of our technology as we progress and lack of acceptance of our methods by the scientific community; the 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; cost of final product higher than expected; loss of market share and pressure on prices resulting from competition; and laboratory results that do not translate into equally good results under actual conditions, which could cause actual results or performance to differ materially from those contemplated by such forward-looking statements. Except as otherwise required by law, Todos Medical undertakes no obligation to release any revisions to 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 see its reports filed from time to time with the United States Securities and Exchange Commission.
Company contact:Daniel Hirsch CFOTodos Medical917-983-4229 ext 104[email protected]
Todos Press Contact:Giancarlo GreagerTreviPR702-768-1906[email protected]
Source: Todos Medical Ltd.