Roche Secures FDA Nod for 15-Minute Pertussis Point-of-Care Test

Roche’s new pertussis test is now cleared for real-world use in the US, marking a major step for faster, front-line diagnosis of whooping cough and other Bordetella infections.

The company stated today that the assay has cleared the FDA 510(k), CLIA waiver and CE IVDR certification, which has made the rapid testing of the assay available in GP practices and Emergency Rooms.

The PCR breakthrough test is based on the small cobas liat platform and takes a short time of 15 minutes to complete. This speed allows clinicians to diagnose pertussis in just one visit, initiate the appropriate antibiotics immediately and aid in preventing further spread of great importance at a time when the number of cases is on the rise.

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Pertussis is a threat to the whole world, which annually leads to more than 24.5 million infections and 170,000 deaths. The initial signs and symptoms can be similar to typical respiratory diseases, and timely and readily available diagnostics is a necessity. In their absence, clinicians have no other option but to treat on a symptom basis, which poses a risk to infants and other high-risk groups due to delays.

According to Matt Sause, CEO of Roche Diagnostics, faster and more precise clinical decision making is essential to curb the occurrence of intense complications and eventual elimination of the spread of Bordetella infections. According to this new test, clinicians are able to make a definite and precise diagnosis to help the patient receive the appropriate treatment at the earliest possible time.