Roche Receives FDA Emergency Use Authorization for PCR Test

Roche, a leading diagnostics company, has recently secured emergency use authorization from the US Food and Drug Administration (FDA) for its cobas liat SARS-CoV-2, Influenza A/B, and respiratory syncytial virus (RSV) nucleic acid test. This real-time RT-PCR assay, which can provide results in just 20 minutes, is specifically designed for use on the cobas liat system.

The test is capable of detecting and differentiating between SARS-CoV-2, influenza A, B virus, and RSV from a single nasopharyngeal or anterior nasal swab sample. With its rapid results and accuracy, the test is expected to streamline clinical decision-making, aid in targeted treatments, reduce unnecessary antibiotic use, and ultimately improve patient outcomes.

Roche’s CEO, Matt Sause, emphasized the importance of diagnostics in combating respiratory illnesses, stating, “We are proud to provide this innovative test to address the significant burden placed on healthcare systems.” He added that healthcare professionals will now have the ability to detect and differentiate these respiratory viruses in a single patient visit, leading to enhanced public health outcomes.

In addition to seeking FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for the test in the US, Roche plans to obtain CE-IVDR approval for commercial launch in other markets. This recent development follows Roche’s FDA breakthrough device designation for the Tina-quant lipoprotein Lp(a) RxDx assay, a diagnostic tool aimed at assessing cardiovascular disease risk.

With the approval of this new PCR test, Roche continues to expand its portfolio of diagnostic solutions for respiratory illnesses, further solidifying its position as a key player in the diagnostics industry.