SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY) said that the U.S. Food and
Drug Administration has granted Emergency Use Authorization for its cobas liat
SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated multiplex
real-time polymerase chain reaction (RT-PCR) assay on the cobas liat system.

Producing results in just 20 minutes on a compact analyser suitable for most
healthcare settings, the test uses either a single nasopharyngeal or anterior
nasal-swab sample to confirm or rule out infection with SARS-CoV-2, influenza A
virus, influenza B virus and respiratory syncytial virus or RSV.

In 2025, Roche intends to seek FDA 510(k) clearance and a Clinical Laboratory
Improvement Amendments of 1988 (CLIA) waiver in the United States for the new
test, with plans for commercial launch in other markets worldwide following
CE-IVDR approval.

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