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Medical Devices / Submissions and Approvals

FDA Hands Vela Diagnostics De Novo Designation for HIV-1 Assay

Nov. 8, 2019

Vela Diagnostics’ IVD test for detecting HIV-1 genomic drug resistant mutations has received the FDA’s de novo designation.

The Sentosa SQ HIV-1 genotyping assay uses a plasma sample from infected patients to find HIV-1 Group M drug resistant mutations in a single test.

The assay runs on the company’s Sentosa NGS platform, which offers automated RNA extraction, polymerase chain reaction setup, sequencing, data analysis and automated reporting, among other features.

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