Todos Medical Completes Validation of 27 Pathogen UTI PCR Panel at Its CLIA/CAP Laboratory Provista Diagnostics
NEW YORK, NY and TEL AVIV, Israel, June 13, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP-certified laboratory Provista Diagnostics has completed validation of a 27-pathogen urinary tract infection (UTI) PCR precision medicine panel. The assay is now in production, and the Company is preparing to launch it commercially. Provista intends to target skilled nursing facilities, ob/gyn and women’s health specialists as primary customers.
The primary benefit of UTI testing using PCR, as compared with current standard methods of cell culture testing, is that PCR is much more sensitive in identifying all of the key bacterial pathogens involved in a UTI, as compared with cell culture that identifies primarily the most prevalent upon cell culture expansion (primarily e.coli). This e.coli pathogen overrepresentation leads to inappropriate therapy selection that results in poor outcomes for patients, including prolonged and worsening symptoms. The second benefit of PCR testing vs. cell culture for UTI, is the rapid turnaround time for (24h-48h) vs. cell culture (3-7 days). For caregivers in skilled nursing facilities, in particular, the rapid identification and resolution of UTI is paramount to avoid potentially significant side effects including incontinence, agitation, lethargy, falls, urinary retention, decreased mobility, decreased appetite, fever, flushed skin, back pain, nausea and vomiting.
“The validation of a second PCR panel beyond COVID-19 establishes Provista’s profile as a precision diagnostics testing company, offering actionable biological information to help physicians and other medical practitioners make more informed treatment selection decisions,” said Dr. Philippe Goix, Chief Commercial Officer at Provista Diagnostics. “Our initial commercial plan is targeted at the skilled nursing facility and Ob/GYN markets that will allow us to expand our customer base towards clients that will be key prescribers of our proprietary breast cancer test Videssa™. We will continue to add precision medicine-based PCR assays and build disease/condition-focused panels, including in the area of Long COVID where we expect there is likely to be an increased risk of breast cancer. We expect that the need for precision medicine solutions that connect diagnostic information directly with therapeutic selection will become increasingly important as COVID and Long COVID are likely to increase the risk for breast cancer, Alzheimer’s disease and other diseases related to the immune system.”
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 the 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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Released June 13, 2022