Test that identifies Strep A within eight minutes cleared by FDA

WALTHAM, Mass. - Alere on Thursday announced that its Alere i Strep A test has received marketing clearance from the Food and Drug Administration. Alere i Strep A is the first molecular test that detects Group A Streptococcus (GAS) bacteria in throat swab specimens in 8 minutes or less.

 

Upon receipt of this clearance from the FDA, Alere submitted an application for CLIA (Clinical Laboratory Improvement Amendments) waiver of the Alere i Strep A test. Other assays currently in development on the Alere i platform include respiratory syncytial virus (RSV), C. difficile and Chlamydia/Gonorrhoea.

 

"This FDA clearance brings the power of our Alere i molecular platform to the detection of Strep A," stated Avi Pelossof, global president infectious diseases at Alere. "The speed and accuracy of the Alere i Strep A test empower healthcare professionals to initiate the right treatment in an actionable timeframe, which is a critical step in reducing unnecessary prescription of antibiotics and enhancing operational efficiency."

 

The Alere i molecular platform was initially cleared for marketing by the FDA for the detection and differentiation of influenza A and B virus in June 2014. In January 2015, Alere i Influenza A & B became the first-ever molecular test to receive CLIA waiver, which allows for broad use by healthcare providers, ranging from hospitals and physician offices to clinics and other healthcare settings. Expanding the menu on the Alere i platform to include Strep A and potentially other assays increases the utility of the platform for a wider range of users. Furthermore, given the less seasonal nature of Strep A, its addition enhances the value of the platform for users on a year-round basis.