Todos Medical to Launch EUA Authorized SARS-CoV-2 cPass

  • Nature Medicine publication shows neutralizing antibodies are essential in preventing or reducing the severity of COVID-19 infection, including infection with emerging variants of COVID-19 such as the Delta variant, for vaccinated populations and not vaccinated
  • Todos now validates cPass in its highly automated CLIA / CAP lab at Provista Diagnostics to enable antibody quantification, high throughput and fast turnaround times
  • Todos will offer cPass as a service through Provista and distribute kits to customer laboratories

New York, NY, and Tel Aviv, ISRAELL, July 19, 2021 (GLOBE NEWSWIRE) – via NewMediaWire Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that it has entered into a distribution agreement with Fosun Pharma for the CPass â„¢ SARS-CoV-2 Neutralizing Antibody Detection Kit * which has received Emergency Use Clearance (“EUA”) from the US FDA for the detection of antibodies of the SARS-CoV-2 receptor binding domain (“RBD” or “neutralizer”). A recent peer-reviewed article published in the scientific journal Nature Medicine concluded: “… Here we show that the level of neutralization is highly predictive of immune protection and provide an evidence-based model of immune protection against SARS-CoV-2 that will help develop vaccine strategies to control the trajectory. future of the pandemic. “

“With the Delta variant posing significant risk of breakthrough infections according to data from Israel, and fears the rise of a potential third wave nationwide, we see neutralizing antibody testing becoming essential for informed decision-making to assess who may be best suited for booster injections, as well as when a person previously infected with COVID begins to show waning immunity and may decide to be vaccinated accordingly, ”said Jorge Leon, Chief Medical Officer for Immunology and Oncology at Todos. “As we begin to learn more about the heterogeneity of the immune response to different COVID vaccines, there appear to be subgroups of people who may need an extra dose of the vaccine to be considered fully vaccinated from the vaccine. neutralizing antibody point of view, and we have now seen last week the Israel Ministry of Health started giving booster shots to immunocompromised and some other risk groups who were found to have low titers of d neutralizing antibodies. Additionally, a recent German study reported that 2% of the general population and more than 30% of people over the age of 80 had no detectable neutralizing antibody levels after their second dose of the vaccine. The cPass test will empower individuals to take control of their health by making data-driven decisions to protect themselves beyond vaccination, such as hiding or avoiding certain high-risk activities when armed with this crucial information. “

Todos sees a great market opportunity developing for cPass which will begin to encroach on the rapidly growing COVID-19 PCR testing market to become an $ 80 billion global market in 2020. We believe immune surveillance will be the main driver of the growth of COVID-19 testing. before. To date, 161 million people in the United States have been vaccinated, with the majority of doses given to older populations who are most likely to show waning immunity the earliest, and will be the first for which decisions reminder will have to be done. As time progresses and more people are 6 months and older from their initial vaccine dose, it will become increasingly important for people and health care providers to assess and monitor neutralizing antibody levels in order to make evidence-based decisions about booster injections. and changes in behavior.

The Company is currently automating the EUA cPass test at its CLIA / CAP laboratory, Provista Diagnostics (“Provista”), to add high capacity neutralizing antibody tests to its test menu, and is intensifying its sales and marketing infrastructure. Provista plans to offer cPass as a testing service to other CLIA labs for reference, as well as directly to the public through healthcare professionals. A key differentiator of this new cPass assay is that it detects neutralizing antibodies in patient samples without using live virus and with very fast turnaround times, compared to the conventional method of measuring neutralizing antibodies in samples. of patients, which requires the use of cells. Once the automation process is complete, Todos expects Provista to deliver high volume results in less than 24 hours. Todos will also make cPass available to customer laboratories so that they can run on their automated equipment.

Todos has also obtained approval to use a high-value version of the cPass test at Provista that has been adapted to quantify levels of neutralizing antibodies, thus allowing levels to be tracked over time. Todos considers this modified test eligible for a higher reimbursement rate than traditional SARS-CoV-2 antibody tests. The company intends to aggressively market Provista’s new testing capabilities in the coming months in order to start capitalizing on its investment in automation and generate high margin revenue growth.

* 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 § 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, researching 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 Videssa® 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 validation of said test kits and supplies at its CLIA / CAP certified partner laboratory in the 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.

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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 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 relating to progress. , the 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 does not undertake 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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