Agreement will enable Meadowlands Diagnostics to offer cPass testing for COVID-19 immunity monitoring to its growing customer base including two additional New Jersey School system contracts
New York, NY, and Tel Aviv, ISRAEL - (NewMediaWire) - August 24, 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 entered into a reference lab agreement to provide cPass neutralizing antibody blood testing services to Meadowlands Diagnostics, a CLIA-certified New Jersey-based provider of laboratory testing services.
Reference lab agreements enable the movement of specimens between labs in order to perform specialized testing that the ordering lab doesn’t have the ability to run in-house. The cPass ELISA blood test has received Emergency Use Authorization from the FDA for the detection of neutralizing antibodies (NAbs) that will allow healthcare professionals and patients to monitor key biomarkers of COVID-19 immunity. Todos has successfully completed the validation studies required to put the cPass Neutralizing Antibody Blood Test for semi-quantitative detection of NAbs into production and expects to begin conducting tests for reference laboratory clients beginning in September 2021. To get more information on the cPass test today please visit Provista’s website www.provistadx.com.
Reginald Samuels, President & CEO of Meadowlands Diagnostics commented, “We see the ability to offer cPass testing as a key differentiator for Meadowlands as we continue to win and pursue COVID related testing contracts in the education, government, and business spaces. Todos has already equipped us with automation and testing consumables for our PCR testing services that has enabled us to win two school district testing contracts in New Jersey that begin testing in the coming weeks, so this reference agreement is a natural progression for our relationship together. We also share a similar vision that immunity monitoring will be critical in determining the need for vaccine boosters or other measures to prevent virus spread. We are excited to be ahead of the curve to begin offering this FDA EUA cleared test to our existing and potential customers, and we look forward to continuing to grow our relationship with Todos.”
Gerald Commissiong, President & CEO of Todos, added, “Providing EUA authorized cPass testing as a reference lab service to CLIA labs across the country is an important component of our COVID-19 immunity monitoring strategy, and we look forward to working with Meadowlands to open this significant market opportunity for both our companies. By having the ability to take reference samples from labs all over the country we are able to leverage those labs’ existing customer bases to win business. Based on the inquiries for cPass received after news of cPass’ validation was made public yesterday, it’s become clear that our automation will serve us well as we capture the significant demand from clinicians and patients. Having this capacity, which we can continue to build well beyond 1,500 cPass tests per day, will allow us to scale the cPass business in a cost efficient manner. We continue to optimize our capabilities to do high volume PCR testing at Provista and look forward to cPass helping drive significant revenue growth for Todos in the coming quarters. We will be focused on reference lab agreements for COVID T-PCR, cPass and COVID variant testing, which we expect to complete validation for in the near future.”
Mr. Commissiong continued, “The pending decision to allow booster shots in the United States at the 8-month point was strongly rebuked by WHO Director-General Tedros Adhanom Ghebreyeses, who called for a two-month moratorium on COVID-19 booster shots in order to enable low and middle-income countries the opportunity to provide vaccines to their citizens. The logical path forward to compromise on this issue is to ensure that the booster shots, which will be in high demand given that the US government has already signaled its intent, be prioritized for the many people that need it whose NAs titers show waning immunity. The cPass test is uniquely capable of identifying which vaccinated individuals need the booster. We look forward to taking a leadership position in helping policy makers make data driven decisions and ensuring that booster shots at least go to those with waning NAbs.”
Provista Diagnostics has the automation in place to do up to 20,000 PCR tests and over 1,500 cPass tests per day. The CMS reimbursement rate per PCR test is $100 and per cPass test is at least $79. Immune monitoring will likely be the primary driver of COVID-19 testing growth in this multi-billion market going forward. To date, over 200 million people in the United States have received at least one COVID-19 vaccine dose, with the majority of the doses having been administered to older populations and the immunocompromised for whom booster shots are being recommended. As time advances, and more and more individuals are 6 months and beyond from full vaccination, it will become increasingly important for individuals, schools, businesses and healthcare providers to asses and monitor NAb levels in order to make data-driven decisions with respect to booster shots and behavioral changes.
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/.
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.
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