Alere Receives FDA Clearance for Alere™ i Strep A

The Alere™ i Strep A test has received marketing clearance from the U.S. Food and Drug Administration (FDA). Alere i Strep A is the first molecular test that detects Group A Streptococcus (GAS) bacteria in throat swab specimens in 8 minutes or less.

Upon receipt of this clearance from the FDA, Alere submitted an application for CLIA (Clinical Laboratory Improvement Amendments) waiver of the Alere i Strep A test. Other assays currently in development on the Alere i platform include respiratory syncytial virus (RSV),

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, Alere i Influenza A & B became the first-ever molecular test to receive CLIA waiver, which allows for broad use by healthcare providers, ranging from hospitals and physician offices to clinics and other healthcare settings. 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. Furthermore, given the less seasonal nature of Strep A, its addition enhances the value of the platform for users on a year-round basis.

Alere’s proprietary Molecular In Minutes™ (MIM) isothermal nucleic acid amplification technology (iNAT). Unlike 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.

The clinical performance of Alere i Strep A was established in a multi-center study conducted in the U.S., in which 481 throat swab specimens were evaluated with Alere i and compared to standard bacterial culture.

• overall sensitivity and specificity of the Alere i Strep A was 95.9% (141/147; 95% CI=91.4%, 98.1%) and 94.6% (316/334; 95% CI=91.6%, 96.6%), respectively.
• All samples generating discordant results between Alere i Strep A and bacterial culture were evaluated by a laboratory developed real-time PCR assay. Of the 6 samples negative by Alere i Strep A and positive by bacterial culture, 4 were also negative for Group A Strep by the real-time PCR assay.
• Of the 18 samples positive by Alere i Strep A and negative by bacterial culture, 13 were also positive for Group A Strep by the real-time PCR assay.

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