Idylla™ Respiratory (IFV-RSV) Panel receives 510(k) clearance by US FDA

Idylla™ Respiratory (IFV-RSV) Panel receives 510(k) clearance by US FDA

- Non-invasive test developed by Janssen identifies respiratory infection in adult and pediatric patients -

Beerse, Belgium (September 5, 2017) – Janssen Diagnostics, a division of Janssen Pharmaceutica NV, today announced that the United States Food and Drug Administration has granted 510(k) clearance for the Idylla™ Respiratory (IFV-RSV) Panel, a diagnostic test developed by Janssen Diagnostics scientists in partnership with Biocartis Group NV. The test offers fast and easy access to molecular diagnostic information and can assist physicians in identifying viral respiratory infections in patients, and thereby enable treatment selection.

The new diagnostic test facilitates the diagnosis of infection from Respiratory Syncytial Virus (RSV) and Influenza virus (IFV) through the detection of a wide array of pathogens, including Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, H275Y mutation of Influenza A subtype 2009 H1, Influenza B and Respiratory Syncytial Virus (A and B). The assay uses samples from nasopharyngeal swabs in Viral Transport Media of adult and pediatric patients and is processed on the Idylla™ system, a fully automated multiplex polymerase chain reaction diagnostic platform that provides results for the IFV-RSV Panel in approximately 50 minutes with less than 2 minutes hands-on time.

IFV and RSV are among the most common human respiratory viral infections and are associated with significant morbidity and mortality globally. Three to five million individuals worldwide develop severe influenza and 250,000 to 500,000 die of Flu-related causes annually.¹ RSV has been estimated to infect 34 million young children each year and causes up to 199,000 fatalities.²

“We are very pleased to receive this 510(k) clearance for the Idylla™ Respiratory (IFV-RSV) Panel,” commented Werner Verbiest, Global Head, Janssen Diagnostics, LLC. “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.”

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea. Follow us on www.twitter.com/janssenEMEA for our latest news.

References:
1. “Influenza (Seasonal)”, World Health Organization (WHO), accessed August 28, 2017, http://www.who.int/mediacentre/factsheets/fs211/en/

2. “WHO Preferred Product Characteristics for Respiratory Syncytial Virus (RSV) Vaccines”, World Health Organization (WHO), accessed August 28, 2017, http://www.who.int/immunization/research/development/ppc_rsv_vaccines/en/

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