On Apr. 21, 2020, Todos Medical announced that Gnomegen has received Emergency Use Authorization from the FDA for its real-time digital polymerase chain reaction diagnostic test for COVID-19. Gibraltar Brothers, a US-based subsidiary of Shanghai Liangrun Biomedicine, added Gnomegen as a supplier of PCR Test Kits to Todos under Gibraltar’s existing agreements. This allowed Todos to use the Gnomegen PCR Test Kits for its CLIA laboratory services business, as well as for distribution through Todos’ network.

Todos is currently validating Gnomegen’s PCR Test Kits in its partner CLIA lab (Provista) where it is also in validation for automated extraction machines to achieve High Throughput status with Centers for Medicare and Medicaid Services (CMS). On April 15, 2020, CMS increased its payment rates for High-Throughput SARS-CoV-2 diagnostic tests that use high-throughput technologies allowing for increased capacity and faster results to $100 per test. A High-Throughput testing lab can process at least 200 specimens per day using “highly-sophisticated equipment that requires specially trained technicians and more more-intensive processes to assure quality,” according to CMS. Provista expects that it can scale up to a capacity of up to 2,000 PCR diagnostic tests per day in May 2020. Provista intends to offer lab services for customers who utilize a variety sample collection methods, including oropharyngeal, nasopharyngeal, stool and saliva.

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.