FDA grants CLIA waiver for Strep A molecular test

FDA has granted CLIA waiver for the Alere i Strep A test. The test, which was cleared for marketing by FDA in April 2015, is the first molecular platform that detects Group A Streptococcus (GAS) bacteria in 8 minutes or less .

Related: FDA grants first-ever CLIA waiver of rapid syphillis test

Alere i Strep A detects GAS bacteria in throat swab specimens using the company’s proprietary Molecular In Minutes (MIM) isothermal nucleic acid amplification technology (iNAT).

With CLIA waiver, the Alere i Strep A test will be available in a broad range of healthcare settings, including physician offices, hospital emergency rooms, and retail and walk-in clinics in the United States.

Related:Strep A rapid molecular test gets FDA clearance

"CLIA waiver expands the access of this test to more patients, which can help drive positive outcomes throughout the integrated delivery network/managed care organization," said Ryan Schmidt, vice president of infectious disease marketing at Alere.

The Strep A test is the second assay on the Alere i 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 CLIA waiver.

GAS pharyngitis causes a considerable cost to society, according to Schmidt. In the United States, it is estimated that GAS pharyngitis in children alone costs between $224 million and $539 million per year. In addition to the acute symptoms of sore throat, GAS can lead to suppurative sequelae, including peri-tonsillar abscess, and nonsuppurative sequelae, including rheumatic fever.

 

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