Latest News
Quidel passes US FDA's clearance to market molecular diagnostic test AmpliVue assay for Group A Strep
29 July 2014 - Diagnostic testing company Quidel (NASDAQ:QDEL) disclosed on Monday the receipt of the US Food and Drug Administration's (FDA) approval to market its AmpliVue GAS Assay for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens.

The company added that 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.

According to the company, the GAS Assay detects the Group A β-hemolytic Streptococcus nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, including sore throat. It requires no upfront extraction of DNA and generates an accurate result in less than one hour.

Group A streptococci are Gram-positive bacteria, primarily residing in the nose, throat and skin; they are responsible for several illnesses, ranging from mild illnesses (strep throat or skin infections) to severe illnesses (necrotizing fasciitis, or streptococcal toxic shock syndrome).

In conjunction, the company's GAS Assay is its fourth molecular infectious disease assay to receive 510(k) clearance from the US FDA in this hand-held, disposable AmpliVue format.

Login
Username:

Password: