Alere Gets 510 (k) Marketing Authorisation For Alere I RSV Rapid Molecular Test

(RTTNews) - Alere Inc. (ALR) Friday said it received FDA's 510(K) marketing clearance for its testing application Alere i RSV Rapid Molecular Test for the detection of Respiratory Syncytial Virus or RSV infection in children and adults. The first molecular test can be used at the point-of-care to detect RSV in 13 minutes or less.

The company said it will file an application for CLIA or Clinical Laboratory Improvement Amendments waiver of the Alere i RSV test. Alere i testing applications have previously been CLIA-waived for Influenza A & B and Strep A.

RSV is a respiratory virus that infects lungs and breathing passages. It is the most common cause of bronchiolitis and pneumonia in children under one year of age. In the U.S., almost 58,000 children under the age of five with RSV infection are hospitalized annually.