You may find more results for this query on our sister sites: GenomeWeb and Precision Oncology News.
The second EUA for a test that targets the ORF1a and N genes is for an automated version of a manual test that had been granted EUA in August.
The Vela and Capstone tests are both PCR-based and designed to detect their viral RNA targets in nasopharyngeal and oropharyngeal swab specimens.
Vela Diagnostics said that the RT-PCR-based test has also received provisional authorization from the Health Sciences Authority in Singapore.
Vela anticipates CE-IVD marking for an automated version of its test, and JN Medsys has received authorization for its test in Singapore and the Philippines.
The funding will support validation of an assay for both manual and high-throughput automated workflows.
The test is a probe-based reverse transcription PCR test for detecting the coronavirus by targeting conserved regions of its genome.
It is the first time that the agency has authorized for marketing a next-generation sequencing test for HIV-1 resistance, the FDA noted.
The test detects genomic drug resistance mutations in HIV-1 that can lead to treatment failure and is validated on the firm's automated Sentosa workflow.
Vela purchased Great Basin for $1.4 million in June, and will reopen its Utah-based lab, rehire employees, and commercialize the firm's infectious disease platform.
The acquisition nets Vela a US manufacturing and R&D site, as well as Great Basin's multiplexing platform and six existing FDA-approved products.