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Todos Medical’s CLIA/CAP Lab Provista Completes Validation of Combination COVID, Influenza A & B, RSV & hMPV Respiratory Panel Test

 

·       CEO Gerald Commissiong to appear on Yahoo! Finance Live Today at 4:10 pm EDT

·       Respiratory panel critical as Back to School begins heading into Fall 2021

·       RSV and Influenza expected to make resurgence with low masking compliance

 

New York, NY, and Tel Aviv, ISRAEL – (NewMediaWire) – September 1, 2021 – Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP certified lab Provista Diagnostics has successfully completed the validation studies required to put the Quidel Lyra Influenza A & B and the Lyra RSV & hMPV PCR kits into production alongside COVID PCR tests currently being run (together the “Provista Respiratory Panel”) and expects this new respiratory panel to be launched in September 2021. The validation coincides with the recent validations for the cPass semi-quantitative COVID neutralizing antibody test and the Kogene COVID variant detection kits also being launched in September 2021. This positions Provista to now offer a turnkey solution for healthcare, businesses, school systems, government agencies, and others seeking access to a high-quality comprehensive lab to support testing programs as the US economy continues its reopening heading into the Fall of 2021.

 

CEO Gerald Commissiong will appear on the Yahoo! Finance Live Show at 4:10 pm EDT today, Wednesday September 1st, 2021 to discuss the recent developments at Provista as well as its plans to advance Tollovir, the Company’s oral, dual mechanism 3CL protease inhibitor/anti-cytokine antiviral drug candidate for COVID-19 treatment currently in a Phase 2 clinical trial for hospitalized COVID-19 patients in Israel. The Company is preparing to expand its trials to include pivotal Phase 2/3 trials in both hospitalized and non-hospitalized COVID patients that it expects to initiate in the coming weeks.

“As the nation heads back to school, and many children head back into classrooms for the first time in nearly 18 months, there is significant risk for a resurgence in influenza and RSV viruses that declined dramatically during the pandemic,” said Gerald E. Commissiong, President & CEO of Todos Medical. “We’ve already seen evidence of a resurgence in RSV over the summer in certain southern states in the US, and now heading into Fall 2021 flu season it is critical that pediatricians are able to make accurate diagnoses so that kids can be quarantined if needed due to COVID, or they can be quickly returned to the classroom when initial symptoms resolve in the event of another respiratory illness as often happens during the school year. Children’s immune systems have largely not been exposed to many respiratory pathogens over the last 18 months, and so it is important that communities are prepared to deal with multiple respiratory illnesses that present with similar symptoms. The major challenge pediatricians will be facing this fall with point of care antigen tests often used for respiratory pathogens is that, similar to COVID, many respiratory illness antigen tests produce false negative results early on in the disease process, and therefore many diagnoses are caught at a second doctor’s visit when symptoms persist or are never properly diagnosed, which is highly frustrating for parents, physicians and patients. The CDC recently updated its guidance to encourage COVID and flu testing simultaneously, and we’ve taken that one step further by adding RSV and hMPV to our PCR respiratory panel because of the dramatic and unexpected rise of these respiratory pathogens over the summer of 2021. By working with Provista, physicians will be able to use the same specimen sample collected for COVID to get highly accurate lab results using PCR for COVID, influenza A & B, RSV and hMPV, so they can have confidence on a treatment plan and the timing of when kids can be returned to the classroom.”

Todos sees a large market opportunity developing for respiratory illness testing that is an adjunct to the COVID-19 PCR testing market that rapidly developed into an $80 billion market worldwide in 2020.  Provista Diagnostics has the automation in place to do up to 20,000 COVID PCR tests, over 1,500 cPass tests per day, over 5,000 COVID variant tests per day, and over 5,000 respiratory panel tests per day when at full capacity.  The CMS reimbursement rate for the Provista Respiratory Panel is $142.

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 (COVID-19) testing materials and supplies. The agreements cover multiple suppliers of PCR testing kits, extraction kits, automation materials and supplies, as well as COVID-19 antibody and antigen testing kits.

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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