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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.
DiaSorin this week completed its acquisition of Siemens Healthineer's microtiter-based ELISA immunodiagnostic business portfolio and related assets.
Quest Diagnostics has completed the acquisition of the outreach services of the William W. Backus Hospital and the Hospital of Central Connecticut.