Todos Medical Announces Clinical Validation and National CLIA Certification for MOTO+PARA Mobile High Complexity Labs
NEW YORK, NY, TAMPA, FL and BATON ROUGE, LA, Nov. 17, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire --Todos Medical (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 the completion of clinical validation and CLIA certification for MOTO+PARA’s mobile lab. The Company’s mobile CLIA lab partner, Integrated Health LLC, has fully validated the clinical performance of the proprietary COVID-19 RT-PCR laboratory testing process performed in MOTO+PARA’s Mobile High Complexity Labs built to biosafety level 3 (BSL3), and has received the approval needed to begin offering COVID-19 screening and analysis as a service to clients anywhere in the United States. Rapid antigen and antibody testing also have been validated and are now ready to be deployed. MOTO+PARA is prepared to accept contracts from prospective clients immediately.
“We are thrilled to begin testing anywhere in the United States and worldwide with our first-of-their-kind mobile labs,” said Eric Canonico, CEO of MOTOPARA Foundation. “With the recent surge of COVID-19 cases, the upcoming holidays predicted to further drive case counts, and the need to pair COVID-19 testing with other tests and emerging vaccination programs, our highly scalable mobile lab solutions are exactly what is needed to address the challenges COVID-19 has placed on existing testing infrastructure. MOTO+PARA is prepared to deploy rapid antigen and antibody tests in addition to diagnostic testing with our onsite RT-PCRs, which can turn results around in as little as 4 hours.”
“We are confident that the validations we have completed and the systems we have implemented will enable high scalability for our mobile labs,” said Jeff Faucheaux, CEO of Integrated Health. “Being able to bring these all-encompassing COVID-19 testing solutions directly to the people will improve the end-to-end testing experience for the patient. This allows us to significantly reduce turnaround times for PCR testing and improve the value of each test we provide because the results will be available more quickly than with traditional lab methodologies.”
“The strategy of deploying all available testing solutions in the nation’s first high complexity mobile labs allows us to assist MOTO+PARA in designing COVID-19 surveillance programs that will meet the diverse needs of different constituents who need access to testing for a myriad of use cases that have emerged since the pandemic began,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Whether it is making highly sensitive PCR testing available to government entities with turnaround times fast enough to dramatically reduce infection risk, screening fans before entering a stadium for sporting events, or supporting disaster relief efforts to ensure emergency responders are working in a COVID-free environment, we believe these mobile labs are the solution to many of the nation’s testing challenges. This distribution channel will also allow us to rapidly commercialize emerging novel COVID-19 lab-based testing and monitoring technologies we expect to come to market in the months ahead. “
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 MOTOPARA Foundation, Inc.
MOTOPARA Foundation, Inc. dba MOTOPARA Foundation™, MOTOPARA™ and MOTO+PARA™ is based in Tampa, Florida, USA, as a not-for-profit corporation incorporated in 2010 as a 501(c)(3), non-profit Private Operating Foundation (POF) under the U.S. Internal Revenue Code. MOTOPARA Foundation serves as an non-governmental organization (NGO) dedicated to the research, development, education and implementation of mobility logistics for Global Disaster First Response™, and healthy sustainable lives connected with sciences, technology, engineering, arts and math, and the professions encompassing such sustainable and renewable resources both domestically and internationally.
MOTO+PARA™ is a neutral nonpartisan NGO providing an elite, asset-based logistics and mobility solution for search and rescue (SAR), reconnaissance (RECON), disaster response and humanitarian relief. It assists fellow NGOs, government agencies and foreign nations in rapid response and secure transport of personnel, supplies, and victims of urgent emergencies and disasters. MOTO+PARA employs full-time Veteran Special Operations Operators and Veterans of Special Operations Support and Logistics Operations who perform mission critical responses utilizing the extensive training and experience gained from their Military service. MOTO+PARA responds by air, sea, and land to get to “ground zero” of a crisis anywhere in the world, using equipment to clear paths and push through to disaster sites while also providing coordinated communications support, power, water, and protection.
MOTO+PARA’s COVID-19 Response is part of its Biological Protective Services & Response Division, which can serve countries around the world with its Mobile High Complexity Laboratories built to BSL-3 specifications, developed jointly with Integrated Health LLC.
About Integrated Health LLC
Integrated Health LLC, based in Baton Rouge, Louisiana, USA, is a health management solutions company with a mobile medical laboratory division that is the first CLIA-certified high complexity mobile laboratory built to BSL-3 specification in the western hemisphere. Integrated Health specializes in ensuring all communities have access to testing and laboratory services, whether urban, rural or extreme remote locations domestically and internationally. Integrated Health’s goal is to become the most innovative and biologically diverse company in the world, and offers an extensive array of testing to meet any community’s diagnostics testing needs.
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 and lab analysis in the United States.
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 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.
Todos Investor Contact:
Kim Sutton Golodetz
LHA Investor Relations
Senior Vice President
Todos Corporate Contact:
(917) 983-4229 ext. 103
Released November 17, 2020