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Alere Receives FDA CLIA Waiver for Alere™ i Strep A Rapid Molecular Test

The U.S. Food and Drug Administration (FDA) has granted CLIA waiver for the Alere™ i Strep A test.

Alere Receives FDA CLIA Waiver for Alere™ i Strep A Rapid Molecular Test

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

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.

“Strep A is highly transmissible, and prompt treatment is critical to reducing the spread of the infection to others. 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 health care,” said Avi Pelossof, Global President of Infectious Disease 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.

About the Alere™ i Strep A test  

Alere™ i Strep A detects Group A Streptococcus (GAS) bacteria in throat swab specimens using Alere’s proprietary Molecular In Minutes™ (MIM) isothermal nucleic acid amplification technology (iNAT). Unlike polymerase chain reaction (PCR) tests, iNAT does not require lengthy and complex thermocycling or DNA purification and can therefore deliver PCR-caliber results more quickly – and in a broad range of settings.

Other assays currently in development on the Alere i platform include respiratory syncytial virus (RSV), C. difficile and Chlamydia/Gonorrhoea.

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