FDA has granted waived status under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the Alere i Strep A test from Alere Inc, Waltham, Mass. Cleared for marketing by FDA in April 2015, the test is the first molecular assay that detects group A Streptococcus bacteria in 8 minutes or less.
With CLIA waiver, the test will be available in a broad range of healthcare settings in the United States, including physician offices, hospital emergency rooms, and retail and walk-in clinics.
“Strep A is highly transmissible, and prompt treatment is critical to reducing the spread of the infection to others,” says Avi Pelossof, global president of infectious disease at Alere. “With CLIA waiver for the Alere i Strep A test, we can help link more people to early treatment by bringing rapid molecular diagnosis to even more settings where they seek healthcare.”
The Strep A test is the second assay on the company’s molecular platform, which initially received 510(k) clearance for the detection and differentiation of influenza A and B virus in 2014. In January 2015, Alere i Influenza A & B became the first-ever molecular test to receive a CLIA waiver. Other assays currently in development include tests for respiratory syncytial virus, Clostridium difficile, and a combined test for Chlamydia trachomatis and Neisseria gonorrhoeae.
For more information, visit Alere.