Quidel Receives FDA Clearance for Its Solana® RSV + hMPV Assay

Quidel Corporation QDEL ("Quidel"), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received clearance from the United States Food and Drug Administration (FDA) to market its Solana^® respiratory syncytial virus ("RSV") + human metapneumovirus ("hMPV") 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 RSV and/or hMPV infections. The Solana^® RSV + hMPV Assay is intended for use only with the Solana® instrument.

"We are pleased to introduce an additional innovative, rapid testing solution that addresses the leading cause of viral respiratory infections in both the young and elderly, RSV and hMPV. This economic and focused approach to testing to detect and differentiate these infections replaces expensive syndromic panels or laboratories capable of performing high complexity testing," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "The Solana RSV + hMPV 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."

Viral infections are the most frequent causes of morbidity and mortality due to respiratory dysfunction worldwide, especially in children under five years of age. Several studies have reported the association of hMPV and RSV with acute respiratory infection. RSV and hMPV share overlapping symptoms, and therefore, cannot be identified or differentiated simply by clinical manifestations^(1,2). The most common clinical symptoms are cough, fever, nasal congestion, and shortness of breath, but may progress to bronchiolitis or pneumonia. RSV and hMPV are also important viral respiratory pathogens in the elderly. In adults greater than 50 years old, hospitalization rates for RSV and HMPV were similar to those associated with influenza⁽³⁾.

The Solana molecular platform leverages Quidel's Helicase-Dependent Amplification (HDA) technology, and in the case of Solana^® RSV + hMPV 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, which is critical during a busy respiratory season when testing volumes are at their highest.

The Solana® RSV + hMPV assay received CE Mark in August, and is Quidel's seventh molecular diagnostic test to receive 510(k) clearance from the FDA in the scalable and versatile Solana format.

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1) Jacques J, Bouscambert-Duchamp M, Moret H, Carquin J, Brodard V, Lina B, et al. Association of respiratory picornaviruses with acute bronchiolitis in French infants. J Clin Virol. 2006; 35(4): 463-6[DOI][PubMed]

2) Matthew J, Pinto Pereira LM, Pappas TE, Swenson CA, Grindle KA, Roberg KA, et al. Distribution and seasonality of rhinovirus and other respiratory viruses in a cross-section of asthmatic children in Trinidad, West Indies. Ital J Pediatr. 2009; 35: 16[DOI][PubMed]

3) Kyle Widmer, Yuwei Zhu, John V. Williams, Marie R. Griffin, Kathryn M. Edwards, and H. Keipp Talbot. Rates of Hospitalizations for Respiratory Syncytial Virus, Human Metapneumovirus, and Influenza Virus in Older Adults. J Infect Dis. 2012 Jul 1; 206(1): 56–62.

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 Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic 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 recently acquired Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide you with diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories. For more information about Quidel's comprehensive product portfolio, visit quidel.com.

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