Strep A rapid molecular test gets FDA clearance

April 2, 2015

FDA has granted marketing clearance for Alere I Strep A Rapid Molecular Test (Alere). The Alere I molecular test initially received marketing clearance in June 2014 for the detection and differentiation of influenza A and B virus, and in January 2015, the test became the first-ever molecular test to receive a Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA.

FDA has granted marketing clearance for Alere I Strep A Rapid Molecular Test (Alere).

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Group A Streptococcus (Group A Strep, or GAS) bacteria is a group of gram positive bacteria responsible for a wide range of both invasive and non-invasive infections. GAS bacteria can live in a person’s nose and throat and can be spread through contact with droplets from an infected person’s cough or sneeze. More than 10 million non-invasive GAS infections occur each year in the United States and although invasive GAS infections are less common, they are associated with a higher mortality rate.

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The Alere I Strep A test detects GAS bacteria in throat swab specimens using Alere’s  proprietaty 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. Alere I Strep A is the first molecular test that detects GAS bacteria in 8 minutes or less.

The Alere I molecular test initially received marketing clearance in June 2014 for the detection and differentiation of influenza A and B virus, and in January 2015, the test became the first-ever molecular test to receive a Clinical Laboratory Improvement Amendments (CLIA) waiver from FDA. The CLIA waiver allows the test to be distributed to a broad variety of non-traditional laboratory site, including physicians’ offices, emergency rooms, health department clinics, and other health care facilities. Upon receipt of marketing clearance for the Alere I Strep A test, the manufacturer has now submitted a CLIA waiver application for this test as well.

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"The speed and accuracy of the Alere I Strep A test empower healthcare professionals to initiate the right treatment in an actionable timeframe, which is a critical step in reducing unnecessary prescription of antibiotics and enhancing operational efficiency," said Avi Pelossof, Global President of Infectious Disease at Alere.

FDA marketing clearance was based on a multi-center study, in which 481 throat swab specimens were evaluated with Alere I Step A compared to standard bacterial culture. The Alere I Strep A test had an overall sensitivity of 95.9% and a specificity of 94.6%. Other assays currently in development for the Alere I system include respiratory syncytial virus (RSV), C. difficile and chlamydia/gonorrhea.