Home Cellular health Todos Medical Launches Validation Plan for PCR-Based MonkeyPox Test at CLIA/CAP Provista Diagnostics Clinical Trials Lab

Todos Medical Launches Validation Plan for PCR-Based MonkeyPox Test at CLIA/CAP Provista Diagnostics Clinical Trials Lab

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§ Lesion collection (standard of care) and planned saliva collection

§ Peer-reviewed publication demonstrating sensitivity of saliva testing opens door to asymptomatic testing

New York, NY, and Tel Aviv, ISRAEL, Aug. 03, 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 laboratory Provista Diagnostics has initiated a validation plan for PCR-based MonkeyPox tests. As part of the plan, the company is validating several PCR tests for MonkeyPox and will launch the most sensitive ones for lesion-based and saliva-based sample collection. While lesion-based testing is the current standard of care under CDC guidelines, saliva-based sample collection is currently the subject of intense research that could open up the possibility of testing patients who are asymptomatic or at a very early stage at high risk of severe disease (such as as immunocompromised patients) which could lead to earlier diagnosis and early intervention with therapeutic drugs such as Tecovirimat (TPOXX). TPOXX is an investigational drug candidate and is currently only available under an Expanded Access Investigational New Drug (EA-IND) protocol. MonkeyPox tests are being developed as laboratory developed tests (LDTs). A recent peer-reviewed article describing a strong correlation between the sensitivity of lesion- and saliva-based PCR tests was recently published in the journal Eurosurveillance: https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2022.27.28.2200503

“The significant investment we made to automate PCR testing at Provista to maximize COVID testing capacity can now be partially redeployed to MonkeyPox as we prepare to help the country scale up MonkeyPox testing capacity to cope. to the emerging public health crisis,” said Gerald E. Commissiong, President and CEO of Todos Medical.

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 state-of-the-art and patented Biochemical Infrared Assays (TBIA) is a proprietary cancer screening technology using peripheral blood analysis that examines the influence of cancer on the immune system, looking for changes biochemicals 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 US medical diagnostics company Provista Diagnostics, Inc. to obtain the rights to its CLIA/CAP-certified laboratory based in Alpharetta, Georgia, which currently performs COVID PCR testing, Long COVID signand Provista’s exclusive Videssa® breast cancer screening blood test.

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 Israel-based majority-owned joint venture 3CL Pharma, Ltd with NLC Pharma in March 2022 to consolidate all intellectual property pursuing the development of diagnostic tests targeting the 3CL protease, as well as protease inhibitor botanicals and pharmaceuticals 3CL that target a fundamental reproductive mechanism of coronaviruses. 3CL Pharma, through the Todos brand, has commercialized the 3CL protease inhibitor immune support dietary supplement Tollovid® in the United States, is developing the dual mechanism 3CL protease inhibitor and anti-cytokine therapeutic drug candidate Tollvir ®, while also developing the diagnostic 3CL protease inhibitor TolloTest™.

To purchase Tollovid, please visit Amazon Where www.MyTollovid.com. For more information, please visit https://www.todosmedical.com/.

Forward-looking statements
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 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 funds necessary 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 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
CFO
All medical
917-983-4229 ext. 104
[email protected]


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