The first molecular test that can detect Group A Strepotococcus bacteria in throat swab specimens in eight minutes or less — Alere’s i Strep A test — has won FDA 510(k) clearance, the Waltham, Mass., diagnostics maker announced Thursday.
The test saves time by using Molecular in Minutes isothermal nucleic acid amplification technology, which does not require time-consuming and complex thermocycling or DNA purification, and delivers test results much more quickly, the company said.
The test’s efficacy was demonstrated during a multicenter clinical trial where 481 throat swab specimens were evaluated using the test and then compared to a standard bacterial culture. The results indicated the test showed an overall sensitivity of 95.9 percent and specificity of 94.6 percent, the diagnostics maker said.
The FDA approval allows physicians to initiate proper treatment in a more actionable timeframe, which is crucial in reducing unneeded antibiotics prescriptions and increasing efficiency, said Avi Pelossof, Alere global president of infectious disease.
After receiving FDA clearance, Alere filed a Clinical Laboratory Improvement Amendments waiver application for the test, which would enable broad healthcare provider use if accepted. Alere’s i molecular platform was FDA-cleared in 2014 to test for influenza A & B, with that test becoming the first of its kind to receive a CLIA waver in January. — Jason Scott