Quidel Receives FDA Clearance for Strep DiagnosticMonday, July 28, 2014
Quidel Corp., a San Diego-based diagnostics company, has received FDA clearance for its molecular diagnostic test, AmpliVue GAS Assay, used for detecting Group A strep.
The handheld device is disposable, does not require culture confirmation of negative results, requires no upfront extraction of DNA and generates an accurate result in less than an hour.
Quidel's (NASDAQ: QDEL) AmpliVue will be used for detecting bacteria residing in the nose, throat and skin responsible for illnesses ranging from strep throat and skin infections to more severe illnesses such as toxic shock syndrome.
AmpliVue does not require the customer to invest in any upfront testing costs, which can lead to lower laboratory costs to adopt and maintain molecular testing methods.