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Roche Cobas 5800, HIV-1 Assay Gets Premarket Approval from FDA

NEW YORK – Roche announced on Tuesday that it has received premarket approval from the US Food and Drug Administration for its Cobas 5800 molecular diagnostics system and an assay to detect HIV-1.

The Cobas 5800 is a compact PCR system that can return up to 144 results in an eight-hour period enabling up to eight hours of walkaway time, Roche noted in a statement. The fully automated workflow is capable of running multiple assays simultaneously and includes sample transfer and preparation, amplification and detection, result determination, and delivery of results to a laboratory information system.

Roche obtained the CE mark on the system last year, followed by the CE mark for tests to detect hepatitis B, hepatitis C, HIV-1, and a qualitative HIV-1/HIV-2 test, as well as assays to detect SARS-CoV-2, and a multiplex test detecting SARS-CoV-2, influenza A, and influenza B.

"The new system furthers our commitment to improve patient care by broadening access to high quality test results so clinicians can make the best treatment decisions for their patients," said Matt Sause, president and CEO of Roche Diagnostics North America.

The Cobas 5800 system and HIV-1 assay will be commercially available in Q4, the firm said.