Todos Medical Announces Distribution Agreement with Adial Pharmaceuticals to Market the FDA, EUA Authorized, Assure/FaStep(R) Point-of-Care Covid-19 Antibody Tests
NEW YORK, NY, REHOVAT, ISRAEL, SINGAPORE, CHARLOTTESVILLE, VA / ACCESSWIRE / October 22, 2020 / Todos Medical (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 firstname.lastname@example.org.
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.
For more information, please visit https://www.todosmedical.com/.
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company's lead investigational new drug product, AD04, is a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company's proprietary companion diagnostic genetic test. A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns (there were no statistically significant serious adverse events reported). AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling and obesity. www.adialpharma.com.
Forward Looking Statements
This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding adding a rapid antibody test that has received an Emergency Use Authorization as a point of care test dramatically increasing the settings in which Todos is able to provide for its growing list of clients, there being significant synergy in selling complementary COVID-19 tests in the marketplace, Todos developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease, and the potential of Adial's AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, Todos ability to dramatically increasing the settings in which it is able to provide for a growing list of clients, Todos ability to sell complementary COVID-19 tests in the marketplace, Todos ability to develop blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease, Adial's ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, Adial's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to its ability to promote or commercialize its product candidates for specific indications, Adial's and Todos' respective ability to maintain their license agreements, continue maintenance and growth of their patent estates and to establish and maintain collaborations, Adial's and Todos' respective ability to obtain or maintain the capital or grants necessary to fund research and development activities, and Adial's and Todos' respective ability to retain key employees or maintain their respective Nasdaq and OTCQB listings. These risks should not be construed as exhaustive and should be read together with the other cautionary statements included in Adial's Annual Report on Form 10-K for the year ended December 31, 2019, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission and Todos' Annual Report on Form 20-F for the year ended December 31, 2019 and subsequent Reports on Form 6-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
For Adial Pharmaceuticals, Inc.
Crescendo Communications, LLC
David Waldman / Natalya Rudman
Tel: (212) 671-1021
For Todos Medical Ltd.
Kim Sutton Golodetz
LHA Investor Relations
Senior Vice President
Todos Corporate Contact:
(917) 983-4229 ext. 103
SOURCE: Adial Pharmaceutical, Inc.
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Released October 22, 2020