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Quidel Receives FDA Clearance for Its New Solana Molecular System and Assay for Diagnosis of Group a Streptococcal Infections

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market Quidel's new instrumented molecular system -- Solana -- and for the Solana Group A Strep Assay (Solana GAS Assay) for the rapid, qualitative detection of β-hemolytic, Group A Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens from patients with signs and symptoms of pharyngitis, such as sore throat.

The Solana molecular platform leverages the Helicase-Dependent Amplification (HDA) technology that is resident in Quidel's AmpliVue® molecular product line to generate a fast and accurate test result. Solana can process up to 12 patient samples in each 30-minute run, thereby providing time-saving workflow advantages to healthcare professionals in moderately complex settings.

The Solana Group A Strep Assay is an easy-to-use, rapid 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 approximately 30 minutes.

Group A streptococci are Gram-positive bacteria, primarily residing in the nose, throat and skin; these bacteria are responsible for several illnesses, ranging from comparatively mild illnesses (e.g., strep throat, otitis media, or skin infections) to severe illnesses (e.g., necrotizing fasciitis and streptococcal toxic shock syndrome).(1) Strep throat (streptococcal pharyngitis) is the most common illness caused by 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 to receive FDA clearance for the Solana system," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We believe that Solana is uniquely positioned in the marketplace because it offers customers the ability to batch the more commonly-run assays, provides superb clinical accuracy, and can also serve as an elegant batch method for confirmation of rapid immunoassay results when needed."

With the 510(k) clearance of Solana, Quidel now offers three molecular platforms -- AmpliVue, Lyra, and Solana -- that are designed to meet the unique needs of customers in different market settings. Combined, they provide for the enhanced diagnosis of fourteen (14) different infectious diseases, including those caused by Influenza A, Influenza B, hMPV, RSV, Group A Strep, Groups C/G Strep, Group B Strep, C. difficile, Bordetella pertussis (whooping cough), adenovirus, parainfluenza virus, HSV 1, HSV2, and Trichomonas.


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