Alere Snags FDA CLIA Waiver for i Strep A Test
The FDA has granted Alere’s i Strep A test CLIA waiver, the Waltham, Mass., devicemaker said Thursday.
Approved in April, the molecular diagnostic assay detects Group A Streptococcus bacteria, a highly transmissible pathogen, in eight minutes or less, the company says. The waiver allows the test to be available in healthcare settings.
The i platform was 510(k)-cleared for influenza A and B detection last year.
In January, the platform became the first molecular assays to be granted CLIA waiver, the devicemaker claims. — Jason Scott