CYPRESS, Calif. and MADISON, N.J., April 15, 2015 /PRNewswire/ -- 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.
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
Focus Diagnostics, Inc., a business of Quest Diagnostics, develops and manufactures the Simplexa line of molecular test products operating on the Integrated Cycler, a compact, portable testing platform, as part of a global collaboration with 3M. Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus in May 2010. Additional Simplexa tests aid in the detection and differentiation of influenza A, influenza B and RSV, Clostridium difficile and HSV 1 & 2. The Simplexa/3M technology has won several industry awards for medical innovation, including twice winning the prestigious Medical Design Excellence Award. In addition to Simplexa, Focus Diagnostics' products sold worldwide include HerpeSelect™ type-specific HSV serology and West Nile Virus DxSelect™. To learn more or to order Simplexa and other Focus Diagnostics tests, please contact Focus Diagnostics at 800-838-4548 or visit www.Focusdx.com.
Focus Diagnostics, Inc., a business of Quest Diagnostics, develops and manufactures the Simplexa line of molecular test products operating on the Integrated Cycler, a compact, portable testing platform, as part of a global collaboration with 3M. Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus in May 2010. Additional Simplexa tests aid in the detection and differentiation of influenza A, influenza B and RSV, Clostridium difficile and HSV 1 & 2. The Simplexa/3M technology has won several industry awards for medical innovation, including twice winning the prestigious Medical Design Excellence Award. In addition to Simplexa, Focus Diagnostics' products sold worldwide include HerpeSelect™ type-specific HSV serology and West Nile Virus DxSelect™. To learn more or to order Simplexa and other Focus Diagnostics tests, please contact Focus Diagnostics at 800-838-4548 or visit www.Focusdx.com.
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