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Quidel's Solana RSV/hMPV Test Clears FDA

NEW YORK (GenomeWeb) – An assay from Quidel to detect and differentiate respiratory syncytial virus and human metapneumovirus has received marketing clearance from the US Food and Drug Administration.

The Solana RSV + hMPV assay detects viral RNA from nasal and nasopharyngeal swabs and runs on the firm's Solana molecular testing instrument. It requires no upfront extraction of RNA and generates an accurate result in approximately 45 minutes, according to the firm.

RSV and hMPV are leading causes of viral respiratory infections in both the young and the elderly, Bryant said, and an economical and focused approach to testing for detection and differentiation of these infections could replace expensive syndromic panels and laboratories capable of performing high-complexity testing.

The Solana platform employs the firm's helicase-dependent amplification (HDA) technology. The RSV and hMPV assay also uses a novel reverse-transcriptase HDA that is used in Quidel’s AmpliVue molecular product line to generate fast and accurate test results. Solana can process up to 12 patient samples per 45-minute run, potentially providing workflow advantages to moderately complex settings that can prove critical during a busy respiratory season. 

The assay received the CE Mark in August, according to the firm, and is Quidel's seventh molecular diagnostic test to receive 510(k) clearance from the FDA in the Solana format. Others include HSV 1+2/VZVComplete (Strep A + C/G)Influenza A+B, a Trichomonas assay, and an assay for Clostridium difficile. Quidel is reportedly working with one of its larger distribution partners in the US on a Solana sales "blitz" program and believes it could soon see an acceleration in molecular sales.

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