Focus Diagnostics, the clinical-laboratory products business of Quest Diagnostics (NYSE: DGX), today announced the FDA 510(k) clearance and CLIA moderate-complexity categorization for its Simplexa Group A Strep Direct Kit. Simplexa Group A Strep Direct is a real-time polymerase chain reaction assay for the detection of Group A Streptococcus bacteria directly from throat swabs.
The most prevalent form of Group A Streptococcus (GAS) is strep throat (pharyngitis), a condition most common in children aged 5-15. More than 600 million cases of strep pharyngitis are estimated to occur worldwide each year. Sore throat, a common symptom of strep pharyngitis, is responsible for 7.3 million pediatric out-patient visits in the United States.
"Fast, reliable diagnosis of strep can make a world of difference in the effectiveness of treatment for this highly prevalent and painful bacterial infection," said Hollis (Holly) J. Batterman, MD, medical director, infectious diseases, Focus Diagnostics. "Our Simplexa Direct Strep test uses a proprietary technique to provide results in as quickly as an hour, compared to up to two days for culture, and has better specificity than rapid antigen tests, which are prone to false negatives. 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."
"Simplexa Direct Strep reflects our vision to provide diagnostic insights that help physicians and patients take prompt, well informed actions to achieve a favorable outcome," Dr. Batterman added.
Simplexa tests, designed for use on the 3M™ Integrated Cycler, employ real-time polymerase chain reaction (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.
The Simplexa Group A Strep Direct test is intended for the in vitro qualitative detection of group A Streptococcus from throat swabs collected from human patients with signs and symptoms of pharyngitis, such as sore throat. Simplexa Group A Strep Direct showed strong performance in clinical studies, with 97.4% sensitivity and 95.2% specificity compared to culture.
The test is also categorized as moderate complexity, enabling some physician offices, community hospitals, health clinics and integrated delivery networks to perform the test directly. Molecular tests are typically categorized as high-complexity, under the Clinical Laboratory Improvement Amendments, and can only be performed in certain reference and complex hospital labs.
"With moderate complexity classification and a streamlined workflow, our Simplexa Direct Strep test could potentially benefit a large number of the many millions of people suspected of strep each year," said Michelle Tabb, PhD, Vice President of Research and Development for Focus Diagnostics. "That's a major advantage over other molecular methods of diagnosing Group A Strep, which may be more labor intensive to perform."
The test was CE marked for distribution in the European Union in February 2015. The test kit is now available directly in the United States and internationally through the global distribution network of Focus Diagnostics.