NEW YORK – The US Food and Drug Administration announced Thursday that Cepheid's test for SARS-CoV-2, influenza, and respiratory syncytial virus received Emergency Use Authorization for use in high and moderate complexity laboratories and at the point of care.
The rapid multiplex RT-PCR test detects and differentiates SARS-CoV-2, influenza A and B, and respiratory syncytial virus RNA and can provide results in 35 minutes.
The test runs on the company's GeneXpert Dx and GeneXpert Infinity instruments in CLIA-certified moderate and high complexity labs and is indicated for use with nasopharyngeal and nasal swabs and nasal wash/aspirate specimens. The Xpert Xpress SARS-CoV-2/Flu/RSV test runs on the GeneXpert Xpress System at the point of care and is authorized for nasopharyngeal and nasal swabs in CLIA-waived settings.
The Danaher subsidiary announced plans to launch the multiplex test during its second quarter earnings call in July. Cepheid was the first company to receive EUA for a point-of-care test for SARS-CoV-2 in March.