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.
The company, which also said it is short on funds, may have to pay $18.3 million to Hudson Bay Master Fund if forebearance is not granted for the default.
The firm said that a number of hospitals and labs are expected to evaluate the panel, presenting it with about a $2.0 million annual revenue opportunity.
Great Basin plans to use the proceeds for R&D, sales and marketing expenses, the redemption of certain notes, and general corporate purposes.
The company had previously said it expected to raise $3.5 million through the public offering of units.