Todos Medical Confirms SARS-CoV-2 PCR Test Kits Used at CLIA/CAP Lab Provista Diagnostics Detect Omicron Variant
Provista to also utilize Osang’s High-Capacity Reflex Variant PCR Detection Kit that has been confirmed to identify the Omicron variant
New York, NY, and Tel Aviv, ISRAEL - (NewMediaWire) - November 30, 2021 - Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced it has confirmed with its PCR test kit providers that the PCR test kits utilized at its CLIA/CAP certified lab Provista Diagnostics based in the Atlanta, GA area are able to detect a SARS-CoV-2 infection caused by the Omicron variant, as well as all other variants of concern, based on in silico analysis. Provista will also now be providing variant testing services utilizing Osang Healthcare’s Osang GeneFinder™ COVID-19 Variants-I RealAMP Kit (the “Osang Variant Kit”). The Osang Variant Kit has been confirmed to detect all known variants of concern, including Alpha, Beta, Gamma, Delta, Delta Plus and Omicron.
Todos sees a large market opportunity to gain market share based on the number of inquiries that are focused on Provista Diagnostics’ ability to screen for all variants including Omicron. The lab has reached another milestone as it has reached its COVID-19 PCR testing capacity of 20,000 tests daily. The company also has the capacity to do 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. Given the current environment, the company is exploring the idea of purchasing more equipment to stay ahead of the curve with respect to surge capacity. Bringing on new customers without factoring in the ability to meet their needs with the coming surge could be considered irresponsible. Although the lab is not at full capacity, the pipeline projections could place the lab at capacity in the near future. Billing was a crucial part of the automation and the company is pleased to announce the receivables are turning. The business development team is also performing exceptionally well and may need additional capacity to sell in the near future.
“As we continue to build PCR testing volume at Provista, it is critical that we maintain the highest quality standards in helping physicians, patients and customers navigate the rapidly shifting COVID-19 testing landscape by confirming that our existing PCR test kits in use are able to identify the Omicron variant,” said Gerald E. Commissiong, President & CEO of Todos Medical. “The emerging Omicron variant has certainly caused global concern due to its potentially improved ability to escape protection provided by vaccine-induced neutralizing antibodies. In general, we know that newer more virulent SARS-CoV-2 variants can be neutralized with higher vaccine-induced neutralizing antibody titers than less virulent variants. With the Osang Variant Kit, we will begin offering high-capacity reflex reference lab testing services for our clients at Provista so that we can surveil which variants are responsible for positive tests. The turnaround time for the Osang Variant Kit assay is less than 3 hours in 96 or 384-well format, much shorter than the 24h+ it takes to complete genomic sequencing and with much greater capacity, and therefore we can scale variant surveillance using existing technologies in our own lab.”
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/.
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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