Alere ($ALR) announced FDA clearance of its Alere i Strep A test to detect Strep A bacteria in 8 minutes or less using throat swab specimens.
"This FDA clearance brings the power of our Alere i molecular platform to the detection of Strep A," said Avi Pelossof, the company's global president of infectious disease, in a statement. "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."
The diagnostic uses Alere's isothermal nucleic acid amplification technology. Alere says it is faster and simpler than the common polymerase chain reaction (PCR) technology, and can be performed in a variety of settings.
According to the trial results of 481 throat swab specimens, the Strep A test has a sensitivity of 95.9% (meaning the false-negative rate is about 4%), and a specificity of 94.6% (meaning the false-positive rate is about 5%). Bacterial culture testing was used to establish the status of the throat swabs definitively. Alere says a good portion of the Alere i test's erroneous results were also misidentified by a real-time PCR assay.
Strep A (or Group A Streptococcus) results in more than 10 million throat and superficial skin infections per year in the U.S. Because it is not as seasonal as influenza, it should enhance the year-round utility of the Alere i platform, the company says.
Upon earning the clearance, Alere applied for a CLIA waiver from the FDA. A waiver from the Centers for Medicare & Medicaid Services' Clinical Laboratory Improvement Amendments would mean that the test can be carried out in nontraditional, non–CLIA-certified labs, like doctor's offices, emergency rooms and health department clinics.
The FDA has granted several CLIA waivers, but in January, Alere's platform for differentiation between influenza A and B became the first molecular test to receive the distinction, meaning the agency acknowledged that it is a relatively simple test to conduct, and the chances of an erroneous result are slim.
Other assays in the pipeline to run on the Alere i platform include a test for respiratory syncytial virus, Clostridium difficile and chlamydia/gonorrhea.
- read the release