Quidel’s Group B Streptococcus assay gets FDA clearance

2 January 2014 (Last Updated January 2nd, 2014 06:30)

Quidel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its AmpliVue Group B Strep Assay, the second to launch in the handheld, disposable AmpliVue format.

Quidel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its AmpliVue Group B Strep Assay, the second to launch in the handheld, disposable AmpliVue format.

AmpliVue Group B Strep Assay is an instrument-free isothermal assay, which combines 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 patients.

It uses amplification technology with an easy-to-use, handheld device.

"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."

Citing statistics from the US Centers for Disease Control and Prevention, Quidel said that between 10% and 30% of pregnant women carry Group B Streptococcus that can be transmitted to newborns during delivery, and CDC guidelines recommend all pregnant women be tested for infection between 35 and 37 weeks of pregnancy.

Quidel 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 now enables laboratories of all sizes to perform highly sensitive and specific molecular tests.

In 2013, the company launched AmpliVue C difficile assay for the detection of toxigenic Clostridium difficile bacterial DNA.

Both assays are now available for sale throughout the US and Europe, while diagnostic tests for other analytes of interest that will use the novel AmpliVue platform are in development.