July 12, 2021: “Quidel Corporation, a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, 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 revolutionary 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.
“Receipt of the CE Mark is an important step forward on our path to commercialize Savanna’s powerful but simple-to-use molecular diagnostic technology,” said Douglas Bryant, president and CEO of Quidel Corporation.
“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 commercialization efforts as we build instrument inventory that we anticipate will be required for our planned broad-scale launch in the U.S.”
About the CE Mark
The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985.
The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives.
These directives not only apply to products within the EU but also for products that are manufactured in or designed to be sold in the EEA.
This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA.
About Quidel Corporation
Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe.
An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S.
Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.
With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world.”
