The single-tube real-time PCR-based test has also received CE marking, according to Seegene, and is now commercially available.
The Centers for Disease Control and Prevention says one of the test reagents will likely need to be remanufactured in its labs.
The EUA allows the test to be used at all CDC-qualified labs in the US on patients who meet CDC criteria for testing for the coronavirus.
Qiagen obtained CE marking for its Therascreen PIK3CA RGQ PCR kit to aid in identifying breast cancer patients with a PIK3CA mutation.
The companies will develop tissue-based companion diagnostics for Amgen's investigational treatment AMG 510 for non-small cell lung cancer.
The seven-year grant renews funding for the Antibacterial Resistance Leadership Group, led by Duke University and UCSF, with $15 million in 2020.
Eurobio Scientific will also develop new test kits for the T-COR 8, a real-time PCR thermocycler originally developed for the US Army.
Mobidiag signed agreements for its Amplidiag and Novodiag products with Alab in Poland and the Ukraine; Biogenetix in Romania; and Theranostica in Israel.
The company delivered organic growth across its four business segments and raised its revenue and earnings guidance for the year.
The FDA clearance follows earlier US marketing approval for the firm's C. Difficile assay.
