Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics solutions company, today announced that it has received a notice of allowance (‘Letter of Intent to Grant a Patent’) from the European Patent Office covering the use of the Company’s proprietary Total Biochemical Infrared Analysis (‘TBIA’) method that uses blood (plasma and/or peripheral blood mononuclear cells ‘PBMCs’) to distinguish between patients with benign tumors vs. malignant tumors vs. no tumors (healthy controls).
The patent application specifically covers methods for capturing consistent data from infrared spectroscopy readers, as well as the application of various artificial intelligence algorithm development methods to the data. The ability of TBIA to make a diagnosis of cancer has first been applied to the detection of breast and colon cancers, where Todos has received CE Marks in Europe paving the way for commercialization initially focused on TMB-2 (dense breast / inconclusive mammogram secondary screening) and TMB-1 (general breast cancer screening) cancer detection tests.
“As we continue to expand our patent position in the blood-based spectroscopy cancer detection market, we are extremely pleased with the progress being made by our development partners in Singapore and Israel who have been steadily advancing our TBIA platform for commercialization outside the US,” said Gerald E. Commissiong, President & CEO of Todos Medical. “TBIA represents a potentially game-changing approach to cancer detection because we will be able to run different artificial intelligence-developed algorithms for multiple cancer types on the same blood sample. While the focus is initially on improving the diagnosis of breast cancer and colon cancer using this method, the potential applies to all cancers. Our vision is to develop a single, simple and cost-effective blood test that can identify any cancer at its earliest stages of formation, and then use emerging methods such as liquid biopsy to monitor patient responses to treatment. Because TBIA is so simple and cost effective to use, we believe that this technology will compete extremely well with liquid biopsy for the cancer screening market. We are positioning for TBIA to become a routine screening test done for cancer in a variety of patient screening settings worldwide.”
In August 2020, the Company entered into a strategic partnership with Singapore-based Pathnova Laboratories, a spinout of Temasek Life Sciences Laboratory, to optimize TBIA’s artificial intelligence cancer detection engine and commercialize TBIA in Singapore. In September 2020, the Company expanded its partnership with Israel-based Care GB by forming a joint venture called BioImagery Ltd. (the “Joint Venture”) to support the commercialization of the cancer portion of Todos’ TBIA immune profiling platform in Israel, Europe and Africa. The management teams at BioImagery and Pathnova have been working closely together to optimize the TBIA cancer detection ahead of commercial launch in those jurisdictions.
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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 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 currently performing PCR COVID testing 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.
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 a strategic partnership with Integrated Health LLC to deploy mobile COVID-19 testing 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 the reproductive mechanism of coronaviruses.