Quidel gains CE mark for combined COVID-19, flu and RSV diagnostic test

Quidel has received a CE mark for its Savanna molecular testing platform and its first assay panel – the Savanna RVP4 Assay – allowing the company to market and sell the system in Europe.

The Savanna molecular platform enables the analysis of up to 12 pathogens or targets, plus controls, from a single assay run in less than 30 minutes.

The initial assay is a rapid, multiplexed nucleic acid test intended for use with the Savanna platform for the detection and differentiation of influenza A, influenza B, respiratory syncytial virus (RSV) and SARS-CoV-2 (COVID-19).

“The Savanna system’s small footprint features integrated sample prep combined with rapid real-time PCR amplification and detection technologies, making it a perfect fit for syndromic testing in hospitals and moderate-complexity labs, with the goal of eventually accessing physician offices, urgent care clinics and other point-of-care location,” said Douglas Bryant, president and chief executive officer of Quidel.

“We expect to deploy our first batch of instruments to select international customers and the performance data generated will support our longer-term commercialisation efforts as we build instrument inventory that we anticipate will be required for our planned broad-scale launch in the US,” he added.