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Todos Medical Achieves Medical Importer Status with US FDA
Todos Medical Achieves Medical Importer Status with US FDA.
About this update from Healixa Inc.
[{"type":"text","content":"\n REHOVOT, Israel, SINGAPORE and NEW YORK, NY, April 15, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Todos Medical Ltd. (OTCQB: TOMDF), a commercial in vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, today announced that the United States Food & Drug Administration has accepted Todos Medical’s application for Medical Device Establishment Registration. This designation allows Todos to import medical devices for commercial sale that have been manufactured by non-US entities. Todos has entered into agreements to import point-of-care (POC) antibody fingerprick blood-based testing kits (Ab POC Testing Kits) and COVID-19 digital PCR-based testing kits from oral/nasopharyngeal swabs, saliva and stool (PCR Testing Kits), as well as automated extraction laboratory equipment (Automated Extraction) to support a newly established risk stratification screening and reflex high throughput diagnostic testing paradigm that it believes will allow for greater access to highly accurate testing in the United States. Todos intends to distribute Ab PCR Testing Kits to medical providers, pharmacies and government entities throughout the United States, and market PCR Testing Kits and Automated Extraction to CLIA/CAP-certified labs in the United States in addition to running PCR Testing Kits using Automated Extraction in its partner CLIA/CAP-certified lab.  About the SARS-CoV-2 Coronavirus (COVID-19) Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses can be transmitted between animals and people and evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China, and additional cases have been found in a growing number of countries worldwide. COVID-19 is the disease caused by SARS-CoV-2. 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 c...