Quidel Receives FDA Clearance for its Solana® RSV + hMPV Assay
October 17, 2017 at 01:30 pm
Share
Quidel Corporation announced 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. 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.
QuidelOrtho Corporation is engaged in vitro diagnostics, developing and manufacturing intelligent solutions. The Company sells its products directly to end users through a direct sales force and through a network of distributors, for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, universities, retail clinics, pharmacies, wellness screening centers, other point-of-care (POC) settings, blood banks and donor centers, as well as for individual, non-professional, over the counter (OTC) use. The Company provides diagnostic testing solutions under various brand names, including AdenoPlus, BIOVUE, FreshCells, InflammaDry, Lyra, MeterPro, MicroVue, Ortho, Ortho Clinical Diagnostics, Ortho Connect, Ortho Plus, Ortho Vision, QuickVue, Quidel, QuidelOrtho, QVue, Savanna, Sofia, Solana, Thyretain, Triage, Virena, Vitros among others. It provides support for its customers across more than 130 countries and territories.