May 1, 2015—Focus Diagnostics, the clinical-laboratory products business of Quest Diagnostics, recently announced the FDA 510(k) clearance and CLIA moderate-complexity categorization for its Simplexa Group A Strep Direct Kit that detects the strep bacteria directly from throat swabs.
Simplexa tests, designed for use on the 3M Integrated Cycler, employ real-time PCR technology to detect DNA or RNA in viruses, bacteria, and other analytes. Using a proprietary chemistry technique that eliminates the nucleic acid extraction process typical of molecular diagnostics, Simplexa tests can produce results in as quickly as an hour. That compares with up to two days for results from culture.
“Fast, reliable diagnosis of strep can make a world of difference in the effectiveness of treatment for this highly prevalent and painful bacterial infection,” Hollis (Holly) J. Batterman, MD, medical director of infectious diseases at Focus Diagnostics, said in a statement. The test was CE marked for distribution in the European Union in February 2015. The test kit is available directly in the U.S. and internationally through the global distribution network of Focus Diagnostics.