FDA approves Solana RSV + hMPV Assay as a diagnostic for infectious disease.- Quidel Corp.

Quidel Corporation announced that it has received clearance from the 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. The Solana RSV + hMPV assay received CE Mark in August.

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.