Todos Medical to Launch EUA Authorized cPass SARS-CoV-2 Neutralizing Antibody Kit Through Agreement with Fosun Pharma

 

  •  Nature Medicine publication shows that neutralizing antibodies are critical to prevent or reduce the severity of a COVID-19 infection, including infection by emerging COVID-19 variants such as the Delta variant, for both vaccinated and unvaccinated populations
  •  Todos now validating cPass in its highly automated Provista Diagnostics CLIA/CAP lab to enable antibody quantitation, high throughput and fast turnaround times
  •  Todos will offer cPass as a service via Provista and distribute kits to client labs

New York, NY, and Tel Aviv, ISRAEL, 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™ SARS-CoV-2 Neutralizing Antibody Detection Kit* that has received Emergency Use Authorization (“EUA”) from the US FDA for the detection of SARS-CoV-2 receptor binding domain (“RBD” or “neutralizing”) antibodies. A recent peer-reviewed paper published in the scientific journal Nature Medicine concluded: “… Here, we show that neutralization level is highly predictive of immune protection, and provide an evidence-based model of SARS-CoV-2 immune protection that will assist in developing vaccine strategies to control the future trajectory of the pandemic.”

“With the Delta variant posing a significant risk for breakthrough infections based on data from Israel, and fears increasing of a potential third wave nationwide, we see neutralizing antibody testing becoming critical for informed decision making to assess who may be best suited for booster shots, as well as at what point someone previously infected with COVID begins to show waning immunity and may decide to receive vaccination as a result,” said Jorge Leon, Chief Medical Officer for Immunology and Oncology at Todos. “As we begin to learn more about the heterogeneity of immune response to different COVID vaccines, there appear to be subgroups of people who may need an additional dose of the vaccine to be considered fully vaccinated from a neutralizing antibody perspective, and we have now seen the Ministry of Health in Israel just this past week begin to give booster shots to the immunocompromised and certain other at-risk groups who were shown to have low neutralizing antibody titers. Additionally, a recent German study reported that 2% of the general population and over 30% of those over 80 had no detectable neutralizing antibody levels after their second vaccine dose. The cPass test will enable individuals to take charge of their health by making data-driven decisions to protect themselves beyond vaccination, such as masking or avoiding certain higher-risk activities when armed with this crucial information.”

Todos sees a large market opportunity developing for cPass that will begin to encroach on the COVID-19 PCR testing market that rapidly developed into an $80 billion market worldwide in 2020. We believe immune monitoring will be the primary driver of COVID-19 testing growth going forward.  To date, 161 million people in the United States have been vaccinated, with the majority of the doses having been administered to older populations who are most likely to show waning immunity the earliest, and will be the first ones for whom booster decisions will have to be made. As time advances, and more and more individuals are 6 months and beyond from their initial vaccine dose, it will become increasingly important for individuals and healthcare providers to asses and monitor neutralizing antibody levels in order to make data-driven decisions with respect to booster shots and behavioral changes.

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

Todos has also been granted authorization to utilize a high value version of the cPass test at Provista that has been adapted to quantitate neutralizing antibody levels, thereby allowing monitoring of levels over time.  Todos sees this modified test as 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 begin to capitalize on its investment in automation and drive high margin revenue growth.

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 analysis that deploys deep examination into cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos' two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe. Todos recently acquired U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing and Provista's proprietary commercial-stage Videssa® breast cancer blood test.

Todos is also developing 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 (PBLs) and monocytes to withstand an 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 cell cycle re-entry 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 entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States. Additionally, Todos has entered into a joint venture with NLC Pharma to pursue the development of diagnostic tests targeting the 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/.

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 only on current expectations of management, 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 the risks and uncertainties related 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 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 the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; 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; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated 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 U.S. Securities and Exchange Commission.

Todos Corporate and Investor Contact:

Richard Galterio

Todos Medical

732-642-7770

rich.g@todosmedical.com


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