On May 11, 2020, Todos Medical announced an exclusive distribution agreement with Gnomegen for the distribution of its digital and quantitative polymerase chain reaction (Digital PCR and qPCR) COVID-19 testing kits in North America, Europe, Southeast Asia and Latin America.  In addition, the Company announced that Gnomegen’s qPCR test received Emergency Use Authorization from the FDA diagnostic test for COVID-19 on May 8th, 2020. Further, the Company announced that it had completed validation testing for the Gnomegen qPCR reagents and was entering preparations to commercially launch the test in the United States through its partner CLIA lab.

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. Todos expects that its CLIA lab partner will be able to process up to 2,000 tests per day with existing equipment, and can ramp up to 7,000 tests per day over the summer of 2020.

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.