Todos Medical (OTCQB:TOMDF) (“Todos”), 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, along with Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that the companies have entered into a distribution agreement whereby Adial has granted Todos Medical non-exclusive sub-distribution rights to the Assure/FaStep® and EcoStep® point-of-care (POC) antibody tests (the “Tests”). The Assure/FaStep received the first U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a serology (antibody) POC test for COVID-19 using fingerstick blood samples as compared with current approved tests that only utilize serum, plasma, or a venous blood draw. See the FDA news release here.
As a result of the FDA’s EUA, fingerstick blood samples can now be utilized with the Tests in POC settings, including doctors’ offices, hospitals, urgent care centers, emergency rooms, or other locations where there is a licensed healthcare professional. The Tests were initially authorized for emergency use in July 2020, to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection, but as with all competing rapid COVID-19 test kits, were not yet authorized for fingerstick blood sample use.
“Adding a rapid, fingerstick antibody test that has received Emergency Use Authorization from the FDA as a point-of-care test to our portfolio is expected to dramatically increase the settings in which we are able to provide COVID-19 antibody testing for our growing list of clients,” said Gerald E. Commissiong, President and CEO of Todos Medical. “We have now established a strong network of high-complexity CLIA lab clients who are implementing our PCR solutions, and we will now add rapid tests to our emerging pharmacy and skilled nursing facility point-of-care sales channel. We believe there is significant synergy in selling complementary COVID-19 tests in the marketplace.”
“This agreement with Todos adds a new element to our sales strategy,” said William Stilley, Chief Executive Officer of Adial Pharmaceuticals. “Todos is seeking to provide comprehensive solutions for COVID-19 testing to their clients, and this agreement allows us to access a new category of clients for Adial. Our agreement was entered into following multiple sales of these Tests to Todos and therefore, we see a market demand from Todos’ clients for these instant and efficient antibody tests to help combat the international COVID-19 pandemic.”
For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.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.
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 Integrated Health LLC and MOTOPARA Foundation to deploy mobile COVID-19 testing in the United States.