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Quidel gets FDA nod for Solana RSV + hMPV assay

Diagnostic testing solutions provider Quidel has secured approval from the US Food and Drug Administration (FDA) for its Solana respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) assay.

Solana RSV + hMPV assay will be used to detect nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.

Solana, which leverages the firm’s helicase-dependent amplification (HDA) technology, can process up to 12 patient samples in each 45-minute run.

In August, the company secured CE mark approval for Solana RSV + hMPV assay.

According to the company, the Solana RSV + hMPV assay is intended for use only with the Solana instrument.

Quidel president and CEO Douglas Bryant said: “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.”

In July, Quidel agreed to acquire Alere’s Triage and BNP businesses for around $440m.

Under the deal, Quidel will acquire Triage MeterPro cardiovascular (CV) and toxicology assets (Triage business) and the B-type Naturietic Peptide (BNP) assay business run on Beckman Coulter analyzers (BNP business) from Alere.

The product lines are being divested to secure antitrust approvals needed for Abbott’s pending acquisition of Alere.


Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.