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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.
News items for the week of Feb. 3, 2020.
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.
Politico notes that the Biden Administration has not yet nominated a permanent Food and Drug Administration commissioner.
Anthony Fauci also informed the World Health Organization executive board that the US would be joining the COVAX initiative, according to CNBC.
A new preprint suggests some SARS-CoV-2 variants could affect the effectiveness of current vaccines, the Associated Press reports.
In Nature this week: Australian lungfish provides details on the movement of vertebrate life from water to land, and more.