Quidel Corporation Granted FDA Clearance for AmpliVue GAS Assay

Quidel Corporation (NASDAQ:QDEL) received clearance from the United States Food and Drug Administration to market its AmpliVue GAS Assay, which is used for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat.

As quoted in the press release:

The AmpliVue GAS Assay is an easy-to-use, handheld disposable molecular diagnostic test that has superb clinical accuracy and does not require culture confirmation of negative results. The assay requires no upfront extraction of DNA and generates an accurate result in less than one hour.

Click here to read the Quidel Corporation (NASDAQ:QDEL) press release