Todos Medical Announces Positive Initial Clinical Proof-of-Concept Data for a Rapid SARS-CoV-2 3CL Protease Detection Assay

NEW YORK, NY, REHOVAT, ISRAEL, SINGAPORE, Nov. 18, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening and diagnosis, and developing blood tests for early detection of cancer and Alzheimer’s disease, today announced positive clinical proof of concept data from its lab-based rapid SARS-CoV-2 3CL protease diagnostic assay in collaboration with its COVID Antigen Test Killer LLC joint venture partner NLC Pharma. The data generated by NLC Pharma in Israel produced 100% sensitivity and 100% specificity in PCR-confirmed positive and negative COVID-19 patient samples. The team is now gathering additional clinical data to submit an emergency use authorization (EUA) to the United States Food & Drug Administration ( FDA) for its lab-based test to be distributed through Todos’ existing lab distribution channels.  Todos is evaluating the best option for the commercialization of its rapid point-of-care version of the 3CL protease assay for the screening and diagnosis of symptomatic and asymptomatic COVID-19 carriers, based on recent updated guidance from the FDA for COVID-19 diagnostic point of care tests.

“The 3CL protease is proving to be an exciting reliable, cost effective and rapid alternative to RNA analysis for detecting SARS-CoV-2,” said Dr. Dorit Arad, PhD, Chief Scientific Officer of NLC Pharma. “We base our technology on sound science, and our assay concept - to detect only the live enzyme activity -  has  advantages over rapid antigen testing that can include high rates of false positives and false negatives. Our rapid test, on the other hand, is based on detecting 3CL protease activity which is present only at the stage when the virus is actively replicating. Thus, an active protease indicates the presence of a live and replicating virus.  Our technology is ideally suited for the high sensitivity detection of individuals infected with replicating virus, regardless of symptom status.”

“Just last week we saw Elon Musk take issue with the lack of consistency with antigen testing, and we wholeheartedly understand his concern,” said Jorge Leon, PhD, Chief Medical & Scientific Officer of Todos Medical. “We believe that our rapid testing 3CL technology will successfully pair with the antigen testing distribution networks being established to bring the point-of-care version of our 3CL assay into the market for widespread uptake as the long-term solution for rapid point of care COVID testing. In the meantime, we will deploy our clinical lab-based 3CL assay together with our existing PCR testing distribution networks to confirm that positive PCR tests are, in fact, picking up actively replicating virus versus inactive viral remnants that can sometimes show false positive RT-PCR results, keeping the person in quarantine needlessly. This would be quite an important addition to the current emerging COVID-19 testing paradigm.”

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About Todos Medical Ltd.

Headquartered in Rehovot, Israel, 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 entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the third quarter of 2020.

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.

Additionally, 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. Todos has formed strategic partnerships with Integrated Health LLC, MOTOPARA Foundation to deploy mobile COVID-19 testing in the United States.

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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 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 Investor Contact:

Kim Sutton Golodetz

LHA Investor Relations

Senior Vice President

(212) 838-3777

Todos Corporate Contact:

Priyanka Misra

Todos Medical

(917) 983-4229 ext. 103


Source: Todos Medical Ltd.