Quidel Corp (QDEL) Announces FDA Clearance for Its Solana Influenza A+B Assay

September 27, 2016 1:15 PM EDT

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Quidel Corporation (NASDAQ: QDEL), 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 its Solana® Influenza A+B assay for the detection of nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection to aid in the diagnosis of Influenza A and B infections. The Solana® Influenza A+B Assay is intended for use only with the Solana® instrument.

According to the Centers for Disease Control and Prevention (CDC), most people who get influenza will recover in several days to less than two weeks, but for some, a "wide range of complications can be caused by influenza virus infection of the upper respiratory tract (nasal passages, throat) and lower respiratory tract (lungs). While anyone can get sick with flu and become severely ill, some people are more likely to experience severe flu illness. Young children, adults aged 65 years and older, pregnant women, and people with certain chronic medical conditions are among those groups of people who are at high risk of serious flu complications, possibly requiring hospitalization and sometimes resulting in death."1

The Solana Influenza A+B assay is an easy-to-use, rapid molecular diagnostic test that has superb clinical accuracy. The assay requires no upfront extraction of RNA and generates an accurate result in approximately 45 minutes.

The Solana molecular platform leverages Quidel's Helicase-Dependent Amplification (HDA) technology, and in the case of Solana® Influenza A+B Assay, a novel Reverse-Transcriptase HDA 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 45-minute run, thereby providing time-saving workflow advantages to healthcare professionals in moderately complex settings.

"Quidel has a long history of innovation, driven by a passionate belief that no child or his grandmother should die unnecessarily of influenza or from complications that arise from an untreated influenza infection. And once again, we're pleased to introduce another innovative testing solution, Solana Influenza A+B, which will address many of the limitations that have hampered the growth of current molecular methods," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "A single Solana instrument system performs up to twelve Solana Influenza A+B assays on almost any sample type or brand of viral transport media in under an hour, and up to 96 patient samples during an 8 hour shift, which is critical during an influenza epidemic when testing volumes are at their highest, and samples are coming from several different locations and often collected in a variety of different transported media."

The Solana® Influenza A+B assay received CE Mark in August, and is Quidel's third molecular diagnostic test to receive 510(k) clearance from the FDA in the scalable and versatile Solana format. Solana® Group A Strep assay for the diagnosis of Group A Strep infections received 510(k) clearance from the FDA in June 2015, and Solana® Trichomonas assay received 510(k) clearance in August.

1 http://www.cdc.gov/flu/about/disease/complications.htm#complications.

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