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Roche's Quadruple Molecular Test for SARS-CoV-2, Influenza A/B, and RSV Granted Emergency Use Authorization by FDA

NextEdge Admin

10 Jun 2024

3 min 29 sec

multiplex PCR,SARS-CoV-2,Influenza A/B,RSV

Roche has received Emergency Use Authorization (EUA) from the FDA for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, designed for swift detection of respiratory viruses. Operating on the cobas® liat system, this automated multiplex real-time PCR assay delivers results in just 20 minutes, utilizing a single nasopharyngeal or anterior nasal-swab sample. Matt Sause, CEO of Roche Diagnostics, emphasized the pivotal role of diagnostics in combating respiratory illnesses, underscoring the significance of this innovative test in alleviating healthcare system burdens and enhancing public health outcomes.

Integrating rapid multiplex PCR diagnostic tests into near-patient care settings like emergency departments and urgent care facilities promises to expedite clinical decision-making, reducing unnecessary antibiotic usage, and facilitating targeted treatment strategies. The CDC reports heightened respiratory disease levels in recent autumn and winter seasons, with SARS-CoV-2 causing a surge in emergency department visits. Particularly vulnerable demographics, such as infants, children, and adults over 65, experienced increased hospitalizations due to respiratory viruses.

Roche's cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test broadens their portfolio of diagnostic solutions, enabling healthcare professionals to efficiently diagnose respiratory illnesses. The company plans to seek FDA 510(k) clearance and CLIA waiver in the United States for the new test, with global commercial launch anticipated following CE-IVDR approval.

This assay is designed for qualitative detection and differentiation of SARS-CoV-2, influenza A/B viruses, and RSV RNA in nasal swab specimens, aiding in clinical decision-making. It's intended for use in certified laboratories under CLIA regulations, with results available in 20 minutes. Positive results indicate the presence of viral RNA, but clinical correlation is necessary to confirm infection status, and negative results should be interpreted alongside clinical observations and epidemiological data.

The cobas liat system, with its automated nucleic acid test instrument, streamlines molecular testing in near-patient settings, offering speed, reliability, and minimal training requirements. The system performs various steps of the testing process, generating definitive results quickly to aid in patient care decisions. Complementing existing assays, the cobas liat SARS-CoV-2, Influenza A/B & RSV Assay marks another milestone in Roche's commitment to addressing respiratory illnesses.