The approval permits the marketing and sale of the Savanna system in Europe and CE mark-accepting countries.
An innovative multiplex molecular platform from Quidel, Savanna allows professional users to assess up to 12 pathogens or targets, as well as controls, using a single sample in under 30 minutes.
It is a sample-to-result automated in-vitro diagnostic system that can carry out real-time polymerisation chain reaction (PCR) tests leveraging the Savanna instrument and Savanna assay cartridges.
When an assay cartridge is inserted, the instrument executes sample and reagent preparation, extracts and amplifies nucleic acid and detects ribonucleic acid (RNA) or deoxyribonucleic acid (DNA) target sequences in real-time.
Indicated for diagnosing related diseases, the completely integrated Savanna system offers qualitative or quantitative results for various types of samples.
It can qualitatively identify and distinguish influenza A, influenza B, respiratory syncytial virus (RSV) and SARS-CoV-2 RNA simultaneously from nasal or nasopharyngeal swabs of patients with respiratory tract infection symptoms.
To be available in an integrated cartridge, which is stable at room temperature, this in-vitro diagnostic test supports the differential diagnosis of infections caused by various viruses.
Quidel Corporation president and CEO Douglas Bryant said: “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 locations.
“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.”
Last month, the US Food and Drug Administration expanded emergency use authorisation to market Quidel’s rapid Covid-19 antigen test device, Sofia Q.