Todos Medical Ltd. (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening and diagnosis, and developing blood tests for the early detection of cancer and Alzheimer’s disease, today announced that it has entered into an agreement with a South Korean manufacturer of rapid diagnostic tests, for U.S. distribution rights to its proprietary 10-minute rapid point-of-care (POC) antigen test (Rapid Antigen) and its proprietary 40-minute rapid POC PCR test (Rapid PCR) for SARS-CoV-2.
Both tests will allow for more convenience and greater access for U.S. consumers seeking fast turnaround times, and both tests have already received Ministry of Food and Drug Safety (MFDS, formerly known as the Korea Food & Drug Administration or KFDA) approval in South Korea. Todos will be assisting in obtaining Emergency Use Authorization (EUA) for each of these molecular tests with the U.S. FDA.
“The addition of the rapid POC Antigen test to improve molecular screening availability and the rapid POC PCR test to dramatically improve confirmatory turnaround times for key at-risk populations, such as skilled nursing facilities, is incredibly important for Todos as we continue the development of total testing solutions for the U.S. market,” said Dr. Jorge Leon, consulting Chief Medical & Scientific Officer of Oncology and Infectious Disease for Todos. “Being able to offer increasingly sophisticated clientele access to every key technology available for SARS-CoV-2 diagnosis and screening is critical as we continue to build our position as a leader in COVID-19 testing in the U.S. We are developing the necessary protocols to make meaningful testing gains, which must be rooted in test accuracy as well as fast turnaround times. Rapid POC tests are a critical tool to help facilitate the expansion of meaningful testing results.”
The Rapid Antigen test runs on a proprietary FIA machine and allows reading of results within 10 minutes of sample collection. The Rapid PCR test runs on a proprietary POC PCR machine and allows for results within 40 minutes of sample collection. The purpose of using these tests in combination is to allow for POC screening with the Rapid Antigen test, and if a positive is found, to utilize the Rapid PCR test to confirm whether the result is a true positive or whether it is due to a prior infection. This is critical for risk mitigation and decision-making purposes.
The Rapid Antigen test has demonstrated sensitivity of 86.49% and specificity of 97.87%, whereas the Rapid PCR test has demonstrated sensitivity of 100% and specificity of 100%. Todos will have access to approximately 1 million rapid POC Antigen tests per week and 1 million rapid POC PCR tests per week upon the tests being granted EUA.
“The continued expansion of product portfolio is a very exciting development as we expand our product offering for stakeholders needing testing in the United States,” said Gerald Commissiong, CEO of Todos Medical. “We are excited to fill the molecular point of care aspect of our COVID testing pipeline as we await data from our proprietary 5 minutes saliva 3C protease test.”
For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid.com
For testing and PPE inquiries, please email email@example.com
About Todos Medical Ltd.
Headquartered in Rehovot, Israel, 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 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. In July 2020, Todos completed the acquired Breakthrough Diagnostics, Inc., the owner of the LymPro Test intellectual property, from Amarantus Bioscience Holdings, Inc. (OTC: AMBS).
Additionally, 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 strategic partnerships with Meridian Health, Moto-Para Foundation to deploy COVID-19 testing in the United States.