July 12, 2021 – Quidel Corporation (San Diego, CA) announced that the company has received the CE Mark for its innovative Savanna multiplex molecular analyzer and Savanna RVP4 Assay (Respiratory Viral Panel-4).
The CE Mark allows Quidel to market and sell the Savanna system in Europe, as well as other countries that accept the CE Mark.
Savanna is Quidel’s multiplex molecular platform that enables professional customers to analyze up to 12 pathogens or targets, plus controls, from a single assay run in less than 30 minutes.
The Savanna system is a fully integrated, sample-to-result automated in-vitro diagnostic platform that performs real-time Polymerization Chain Reaction (PCR) tests by using the Savanna instrument and Savanna assay cartridges. After inserting the assay cartridge, the instrument performs sample and reagent preparation, nucleic acid extraction and amplification, real-time detection of RNA or DNA target sequence, and qualitative or quantitative result interpretation from a variety of sample types.
The Savanna system is intended to aid in the diagnosis of the related diseases.
Quidel’s initial Savanna RVP4 Assay (Respiratory Viral Panel-4) is a rapid, multiplexed nucleic acid test intended for use with the Savanna instrument for the simultaneous qualitative detection and differentiation of influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV), and SARS-CoV-2 RNA isolated from human nasal or nasopharyngeal swabs in media obtained from patients with signs and symptoms of respiratory tract infection.
This in vitro diagnostic test is intended to aid in the differential diagnosis of infections with these viruses. The Savanna RVP4 Assay comes in a fully integrated cartridge that is stable at room temperature.
Douglas Bryant, president and CEO of Quidel, said the company expects to deploy its first batch of instruments to select international customers and that the performance data generated will support our longer-term commercialization efforts as we build instrument inventory that the company anticipates will be required for its planned broad-scale launch in the U.S.