TUESDAY, JUNE 19, 2018

Quidel gains FDA approval for Group B Strep assay

The Quidel Corporation announced on Monday that its AmpliVue Group B Strep Assay for diagnosing Group B Streptococcus was approved by the U.S. Food and Drug Administration for sale in the U.S.

The Quidel Corporation provides rapid diagnostic tests, cell-based virology assays and molecular-level diagnostic devices to a range of medical facilities around the world. It's AmpliVue is a non-instrumented molecular-based diagnostic assay that incorporates amplification technology is a portable, hand-held device.

The AmpliVue Group B Strep Assay uses Quidel's isothermal Helicase Dependent Amplification and lateral flow technology to detect GBS cultures in pregnant women.

GBS can be life-threatening for newborns, causing serious illnesses which include sepsis, meningitis, pneumonia and potentially life-long deafness and developmental disabilities. The U.S. Centers for Disease Control and Prevention estimates between 10 and 30 percent of all pregnant women are carriers of GBS.

"We are pleased to receive 510(k) clearance for our AmpliVue Group B Strep assay," Corporation President and CEO Douglas Bryant said. "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 is now available for use in medical laboratories across the nation and in Europe. It is the second assay the Quidel Corporation has developed that uses its hand-held AmpliVue casing.