FDA Clears the Simplexa™ Group A Strep Direct Test from Focus Diagnostics, a Quest Diagnostics Business
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
"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
"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
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
The test was CE marked for distribution in the
About Strep Throat
Group A Streptococcus (GAS) is a gram-positive bacterium responsible for a wide range of infections. The most prominent of these infections are known as strep throat (pharyngitis), which occur when the bacteria colonizes in the throat. Strep throat is most common in children between ages 5 and 15. Because it shares symptoms, such as painful sore throat and fever, in common with the flu and other respiratory conditions, laboratory testing is an important aid in diagnosis. Untreated strep infections can lead to serious conditions, including Rheumatic fever and Scarlet fever. Strep is typically treated with a course of antibiotics.
About Focus Diagnostics and Simplexa
Quest Diagnostics is the world's leading provider of diagnostic information services needed to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at www.QuestDiagnostics.com.
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