Quidel Receives FDA Clearance for Its Hand-Held Molecular Diagnostic Test for Group A Strep

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that it has received clearance from the United States Food and Drug Administration (FDA) 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 obtained from patients with signs and symptoms of pharyngitis, such as sore throat.

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. Like other previously FDA-cleared AmpliVue assays, the AmpliVue GAS Assay does not require the customer to invest in either expensive thermocycling equipment, or any other upfront testing costs. Using AmpliVue can therefore significantly lower a laboratory's cost to adopt and maintain molecular testing methods.

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).(1) Strep throat, or streptococcal pharyngitis, is the most common illness from Group A streptococcal infections. These bacteria are spread through contact with airborne droplets from an infected person's cough, sneeze or via contaminated items such as eating utensils.(2)

"We are very pleased with the rapid pace of our AmpliVue assay development. Our AmpliVue assay for Group A Strep is our third AmpliVue product to be 510(k)-cleared by the FDA in the last seven months," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our sales force now has a broader suite of fast and accurate molecular assays that offer a compelling value, especially among smaller labs that generally do not test using molecular methods. With respect to diagnosing Group A streptococcal infections, Quidel now has a breadth of diagnostic offerings ranging from the Sofia immunofluoresence-based test to the hand-held AmpliVue molecular assay to the Lyra Strep A + C/G molecular product for higher throughput labs."

Quidel's AmpliVue platform now enables laboratories of all sizes to perform highly sensitive and specific molecular tests. The AmpliVue GAS Assay is Quidel's fourth molecular infectious disease assay to receive 510(k) clearance from the FDA in this hand-held, disposable AmpliVue format. Quidel now offers 510(k)-cleared, in vitro diagnostic products on this novel platform for the diagnosis of five pathogens: C. difficile, Group A Strep, Group B Strep, HSV1 and HSV2.

1. http://www.cdc.gov/ncidod/dbmd/diseaseinfo/groupastreptococcal_g.htm

2. http://www.cdc.gov/Features/strepthroat/

About Quidel Corporation

Quidel Corporation serves to enhance the health and well being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the QuickVue(R), D3(R) Direct Detection and Thyretain(R) leading brand names, as well as under the new Sofia(R), AmpliVue(R) and Lyra(TM) brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories.