Todos Medical Announces Instrument Validation Complete at MOTO+PARA Mobile Lab
NEW YORK, NY, REHOVAT, ISRAEL, SINGAPORE, Oct. 26, 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 the instrument validation in its mobile lab division. The Company’s mobile CLIA lab partner, Integrated Health, has fully validated the analytical performance of the Company’s proprietary ANDis 350 RNA auto-extraction machine in combination with its Accurate 96 qPCR machine as part of the COVID-19 RT-PCR laboratory testing validation process being performed in MOTO+PARA’s Mobile High Complexity Lab. Integrated Health expects to complete the clinical validation needed to support the commercial launch in mid-November. MOTO+PARA is in talks with several entities and expects to begin accepting contracts in mid-November 2020.
“We have spent the last 3 months building the mobile labs system in preparation for a commercial launch with a focus on the highest quality, consistent data generation, and overcoming the many technical challenges that presented themselves in the creation of a highly scalable Biosafety Level 3 built mobile lab,” said Eric Canonico, CEO of MOTOPARA Foundation. “We are pleased to have these high levels of analytical performance in the Todos instruments.”
“We feel extremely comfortable working with these instruments given the quality and consistency of the data we can now generate after spending the last 8 weeks in validation,” said Brandon Albin, Managing Partner at Integrated Health. “We are confident we can commercially launch the COVID-19 qPCR assay using Todos’ testing paradigm and reach capacity of 1000 PCR tests per day per mobile unit, in addition to antigen and antibody testing.”
“We are very excited about the potential of the mobile labs project to increase the availability and quality of testing in the United States and abroad,” said Gerald Commissiong, President & CEO of Todos Medical. “Having the ability to reduce PCR turnaround times from 3-6 days to potentially as little as 3-6 hours is a complete game changer in terms of speed to diagnosis and reducing time to isolation, which would dramatically reduce the potential for a patient to become a close contact to others, as defined by the Centers for Disease Control. We will also be offering COVID-19 antigen screening and surveillance testing, as well as antibody testing to our laboratory and delivery of care partners.
Currently, Integrated Health is in the process of testing 30 known positive and 30 known negative samples to receive CLIA certification allowing MOTO+PARA High Complexity Mobile Labs to operate under Integrated Health’s U.S. national mobile CLIA lab license, authorized in all 50 states in the U.S. The companies expect to reach this milestone in mid-November.
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 a 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 October 26, 2020