NEW YORK (GenomeWeb) – Focus Diagnostics today announced its Simplexa Group A Strep Direct kit has received 510(k) clearance from the US Food and Drug Administration for marketing in the US.
The agency has also categorized the test as moderate complexity, which will allow some clinicians to perform the test directly.
Simplexa Group A Strep Direct is a real-time PCR assay for detecting group A Streptococcus bacteria directly from throat swabs and is indicated for patients who present with symptoms of pharyngitis. In clinical studies it has demonstrated 97.4 percent sensitivity and 95.2 percent specificity compared to culture-based methods, Focus said.
The test is designed for use on the 3M Integrated Cycler and detects DNA or RNA in viruses, bacteria, and other analytes, said Focus, a Quest Diagnostics business. Using a chemistry method that eliminates the need for nucleic acid extraction, Simplexa tests can produce results in as quickly as one hour compared to up to two days needed with culture-based methods.
The assay received CE marking in February.
"Faster diagnosis and subsequent treatment can minimize the risks of infection of others, inappropriate use of antibiotics, and progression to more advanced and potentially life-threatening disease," Hollis Batterman, Focus' medical director, infectious diseases, said in a statement.
FDA has also categorized the assay as moderate complexity, allowing some physicians, community hospitals, health clinics, and integrated delivery networks to run the assay directly. Focus noted that molecular tests are typically categorized as high-complexity under the Clinical Laboratory Improvement Amendments and can be run only by certain reference and complex hospital labs.