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Quidel Receives FDA Clearance for Its Hand-Held Group B Strep Molecular Diagnostic Test

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its AmpliVue Group B Strep Assay. AmpliVue is Quidel's non-instrumented molecular diagnostic test that employs a novel amplification technology with an easy-to-use, hand-held device. The AmpliVue Group B Strep Assay combines isothermal Helicase Dependent Amplification (HDA) with Quidel's well-established expertise in lateral flow technology to detect Group B Streptococcus (GBS) from enriched broth cultures of specimens from antepartum women.

GBS is responsible for illness in people of all ages, but it is a particularly serious pathogen for newborns in whom it can cause life-threatening sepsis, pneumonia and sometimes meningitis with a risk for long lasting effects, including deafness and developmental disabilities.(1) According to the Centers for Disease Control and Prevention (CDC), roughly 10% to 30% of pregnant women carry GBS that can be transmitted to the newborn at delivery. CDC guidelines recommend that all pregnant women should be tested for GBS infection between 35 and 37 weeks of pregnancy.(2)

Although more rare, serious GBS infections can also occur in adults, leading to bloodstream infections, pneumonia, and other infections that can be fatal.(3)

"We are pleased to receive 510(k) clearance for our AmpliVue Group B Strep assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We can now provide the hospital laboratories with another AmpliVue assay for fast, accurate infectious disease testing without the need for additional investments in expensive equipment."

The AmpliVue Group B Strep assay now enables laboratories of all sizes to perform highly sensitive and specific molecular tests and is Quidel's second assay to launch in the hand-held, disposable AmpliVue format. The AmpliVue C. difficile assay was launched earlier this year for the detection of toxigenic Clostridium difficile bacterial DNA. Both assays are now available for sale throughout the U.S. and Europe. Diagnostic tests for other analytes of interest that will use the novel AmpliVue platform are in development.


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