Todos Medical Announces Commercial Launch of Todos Branded COVID-19 qPCR Test Kits in the United States
NEW YORK, NY, Sept. 11, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire – 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 the U.S. Food and Drug Administration (FDA) has added the TODOS 2019-nCoV RT-qPCR Detection Kit to its Notified List under the Emergency Use Authorization program. Todos is required to submit an Emergency Use Authorization application to the FDA within 15 days of submission of the notification.
The Todos test is currently authorized to use only the QuantStudio 12Flex Instrument as a platform to perform the RT-PCR assay. It is estimated that there are more than 1,000 QuantStudio 12Flex Instrument installations in United States. The Company anticipates first shipments of test kits for existing CLIA laboratory clients to begin next week and will be working with those existing clients to complete validations on additional RT-PCR instruments to expand the commercial reach of the Todos test to include additional RT-PCR instruments. The Company currently has access to sufficient raw materials to manufacture approximately 1,000,000 test kits per week and is expanding its warehouse and logistics capabilities to meet an expected surge in demand in the weeks ahead given the testing market’s desire for a highly accurate and analytically stable COVID-19 qPCR test. The Todos test instructions for use (IFU) include use of Todos proprietary ANDis 350 extraction system and extraction reagents that ensure consistency in the RNA extraction and purification process prior to RT-PCR analysis for virus detection.
“We are excited to make our highly sensitive RT-PCR test kits available in the United States as we continue to see spikes in COVID diagnoses in multiple areas,” said Gerald Commissiong, Todos Medical’s President & CEO. “We have taken a thoughtful and measured approach to addressing our nation’s COVID-19 testing bottlenecks, including a shortage of equipment, personnel and reagents, and will now begin to work on reducing lengthy turnaround times for results that often leads to questionable accuracy by focusing on our mobile lab initiatives. These initiatives have been making great strides in the last several weeks and will serve as a new distribution channel for our products.“
“Our goal is to be a one-stop solution for all COVID testing including PCR tests, antigen tests, antibody tests and our proprietary 3C protease rapid test, as Todos begins to play a more prominent role in addressing the global COVID-19 crisis,” Mr. Commissiong continued. “With the full validation of our Todos branded COVID-19 test kits now complete and submissions to FDA ongoing, we are currently validating our proprietary COVID + flu A/B test and intend to submit it to the FDA. Todos is positioning itself as a science-focused leader in the COVID-19 space that will stay at the forefront of the science and medical need in order to provide intelligent solutions that address the key challenges emerging worldwide.”
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.
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.
Kim Sutton Golodetz
LHA Investor Relations
Senior Vice President
Priyanka Misra Todos Medical (917) 882-3733 Priyanka@todosmedical.com
Released September 11, 2020