NEW YORK – Quidel announced on Monday that its Savanna multiplex molecular analyzer and its respiratory viral panel test for use with the instrument have received CE marking.
The Savanna platform can analyze up to 12 pathogens or targets, plus controls, from one sample in less than 30 minutes, Quidel said in a statement. The PCR-based instrument can perform sample and reagent preparation, nucleic acid extraction and amplification, detection of the target sequence, and qualitative or quantitative result interpretation from a variety of samples, it added.
The Savanna RVP4 Assay qualitatively detects and differentiates between influenza A and B, respiratory syncytial virus, and SARS-CoV-2. The rapid nucleic acid test uses nasal or nasopharyngeal swabs and comes in a fully integrated cartridge that's stable at room temperature, San Diego-based Quidel 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," Douglas Bryant, president and CEO of Quidel, said in a statement.
He added that the performance data generated from the initial instrument deployment internationally "will support the firm's longer-term commercialization efforts" and "planned broad-scale launch in the US."
On the company's first quarter earnings call in May, Bryant said Quidel had submitted the panel to the US Food and Drug Administration for Emergency Use Authorization.