On Apr. 15, 2020, Todos Medical announced the U.S. Food and Drug Administration (FDA) 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-U.S. entities. Todos has entered into agreements to import point-of-care antibody fingerprick blood-based testing kits and COVID-19 digital PCR-based testing kits from oral/nasopharyngeal swabs, saliva and stool, as well as automated extraction lab equipment 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 U.S.

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.

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.