Todos Medical Announces 2 New COVID-19 PCR Testing Reference Lab Agreements for CLIA/CAP Lab Provista Diagnostics
Todos Medical, Ltd. (OTCQB: TOMDF) has announced the acquisition of two new reference lab testing contracts through its CLIA/CAP lab, Provista Diagnostics, responding to increased COVID-19 testing demand from laboratories in Georgia and New Jersey. The lab is currently processing an average of 1,000 PCR samples daily, with potential to scale up to 5,000. CEO Gerald Commissiong emphasized the ongoing relevance of COVID-19 testing amid rising Omicron variant cases, predicting a shift to testing mandates as vaccination does not eliminate transmission risks.
- Acquisition of two new reference lab contracts.
- Testing capacity expected to increase from 1,000 to 5,000 PCR samples per day.
- Provista Diagnostics has automation for over 20,000 PCR tests daily.
- Increasing competition in the COVID-19 testing market.
- Uncertainties around regulatory approvals may hinder operations.
- Combined testing from two contracts averages 1,000 PCR samples per day
- Testing potential for the two contracts could ramp up to 5,000 PCR samples per day
New York, NY, Alpharetta, GA and Tel Aviv, ISRAEL, Dec. 07, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP lab Provista Diagnostics has won two (2) new reference lab testing contracts from laboratories collecting samples in Georgia and New Jersey. In the last two weeks both labs referring have experienced a marked uptick in testing demand, primarily from schools, that has caused them to exceed their small testing capacity and required them to identify additional testing capacity available to meet their needs, making them ideal lab clients for Provista. Provista Diagnostics is Todos Medical’s wholly-owned CLIA/CAP certified lab that offers comprehensive, fast, automated COVID-19 testing solutions that help referring labs keep their clients by allowing them to deliver fast turnaround time (TAT) at scale.
“These reference lab contract wins continue to validate our strategy of building COVID-19 testing capacity in preparation for increasing institutional demand,” said Gerald Commissiong, CEO of Todos Medical, Provista’s parent company. “COVID-19 is not disappearing anytime soon. The Omicron variant has already dramatically increased the demand for fast turnaround times worldwide due to increased demands by governments to shorten the window in which a false negative result could allow travelers to import cases. When you add to this pending or already-imposed vaccination mandates that almost all have a universal opt-out with some form of testing, we expect a significant increase in COVID-19 testing demand will hit the market, and we are already seeing signs of that as evidenced by these two reference lab agreements. Given that it appears the Omicron variant is highly transmissible even among the fully vaccinated, as evidenced by the super spreader event at a restaurant in the Netherlands, we expect that the vaccine mandate will evolve into a testing mandate because even the vaccinated are now high-risk of contracting and spreading the virus. While we expect the vaccines to maintain their efficacy in preventing hospitalization and death, the fact that the virus can be spread among the vaccinated likely significantly increases the risk for Long COVID given that emerging data suggests Long COVID potentially remains a significant risk independent of vaccination status. With this backdrop, the most prudent course of action is to implement widespread testing, and we see policymakers being forced to move in that direction regardless of vaccination status. While serial rapid testing does appear to be an effective tool in identifying cases, in the absence of widespread serial use, only the PCR test should be used to certify infection status. Given what we are hearing from US policymakers, we do not expect rapid antigen tests to be made widely available in the United States, and so PCR testing will dominate.”
Provista currently has the automation setup and in place to conduct over 20,000 COVID-19 PCR tests per day. The lab also has the automation in place to conduct over 1,500 cPass semi-quantitative neutralizing antibody tests per day, over 5,000 COVID variant tests per day (including testing for the Omicron variant that is being implemented now by PCR variant kit) and over 5,000 respiratory panel tests per day.
For more information, please visit www.todosmedical.com. For more information on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com. For referring labs interested in the COVID-19 PCR, variant, cPass neutralizing antibody body and/or respiratory panel testing services Provista offers, please email Sr. Director of Business Development James Doherty at dohertyj@provistadx.com for further information.
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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