Coronavirus company news summary – GenePath receives approval to sell PCR test in India – Maxim to sell three million Covid-19 antigen tests

7 September 2020 (Last Updated September 7th, 2020 09:08)

GenePath Diagnostics, a company based in Pune, India, has received approval to manufacture and sell its Covid-19 RT-PCR test kit from Central Drugs Standard Control Organisation (CDSCO). Times of India has reported that GenePath is the second company from Pune to receive approval to manufacture Covid-19 PCR test kits.

Novacyt has launched a CE approved Covid-19 PCR two gene target test. This test offers an additional option to the company’s single gene test, addressing the needs of a number of countries which require a two gene target testing approach for Covid-19.

Roche has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 & Influenza A/B Test. The test will be used on the cobas 6800/8800 Systems. It is expected to detect and differentiate SARS-CoV-2, Influenza A and Influenza B simultaneously in suspected patients, and will be available in countries which accept the CE Mark.

Maxim Biomedical has planned to manufacture and sell around three million Maxim SARS-CoV-2 Rapid Antigen Diagnostic Tests by the end of this year. The company added that the patent is pending for the test. Maxim developed the test in partnership with National Institutes of Health (NIH) via the Rapid Acceleration of Diagnostics (RADxSM) initiative.