Janssen’s respiratory panel wins 510(k) clearance

Johnson & Johnson (NYSE:JNJ) subsidiary Janssen Diagnostics said today that it won 510(k) clearance from the FDA for its Idylla respiratory panel.

The diagnostic test, developed in partnership with Biocartis Group, helps physicians identify viral respiratory infections, including infection from respiratory syncytial virus and influenza virus.

The company’s assay uses nasopharyngeal swabs to collect samples and processes them on the Idylla system – a multiplex PCR diagnostic platform that provides results in approximately 50 minutes, according to J&J.

IFV and RSV are among the most common human respiratory viral infections, the healthcare giant said.

“We are very pleased to receive this 510(k) clearance for the Idylla Respiratory (IFV-RSV) Panel,” Werner Verbiest, global head of Janssen Diagnostics, said in prepared remarks. “We hope this innovative diagnostic test will help physicians in the U.S. develop more precise and personalized treatment strategies to help patients facing these widespread and potentially fatal viruses.”

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