The US Food and Drug Administration (FDA) has approved marketing clearance for the Alere i Strep A test (Alere Inc), the first molecular test that detects group A streptococcus bacteria in throat swab specimens in 8 minutes or less, the company said today.
"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," Avi Pelossof, Alere's global president of infectious disease, said in a news release.
Alere has submitted an application for a Clinical Laboratory Improvement Amendments waiver for the test, which would allow it to be used in nontraditional laboratory sites such as physician offices, hospital emergency departments, and health department clinics.
The new test uses Alere's proprietary Molecular in Minutes isothermal nucleic acid amplification technology. Unlike polymerase chain reaction tests, isothermal nucleic acid amplification technology does not require lengthy and complex thermocycling or DNA purification, and can therefore deliver polymerase chain reaction–caliber results more quickly and in a broad range of settings, the company notes.
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, the Alere i Influenza A & B Test became the first molecular test to receive a CLIA waiver.
"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," the company said. "Furthermore, given the less seasonal nature of Strep A, its addition enhances the value of the platform for users on a year-round basis."