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Todos Medical Announces Commercial Launch of Todos Branded COVID-19 qPCR Test Kits in the United States
Todos Medical Announces Commercial Launch of Todos Branded COVID-19 qPCR Test Kits in the United States.
About this update from Todos Medical Ltd.
[{"type":"text","content":"\n 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 initia...