Quidel receives CE mark for Savanna® multiplex molecular analyzer and respiratory viral panel
SAN DIEGO – (COMMERCIAL THREAD) –Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic test, cell virology and molecular diagnostic systems solutions, today announced that the company has received CE Mark for its innovative Savanna® Multiplex Molecular Analyzer and its Savanna® RVP4 test (Respiratory Viral Panel-4). The CE mark allows Quidel to market and sell the Savanna system in Europe, as well as in 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, as well as controls, from a single test in less than 30 minutes. The Savanna system is a fully integrated automated system, from sample to result in vitro Diagnostic platform that performs real-time polymerization chain reaction (PCR) testing 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 target RNA or DNA sequence, and qualitative or quantitative interpretation of results from various types of samples. The Savanna system is intended to aid in the diagnosis of associated diseases.
Quidel’s Respiratory Viral Panel-4 (Savanna RVP4) Initial Assay is a rapid multiplexed nucleic acid test intended for use with the Savanna instrument for the simultaneous qualitative detection and differentiation of influenza A (Influenza A), influenza B (Influenza B), 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.
“Obtaining the CE mark is an important step on our path to bringing Savanna’s powerful yet easy-to-use molecular diagnostic technology to market,” said Douglas Bryant, President and CEO of Quidel Corporation. The Savanna system’s small footprint includes integrated sample preparation combined with fast real-time PCR amplification and detection technologies, making it a perfect choice for syndromic testing in hospitals and complex laboratories. moderate, with the goal of eventually gaining access to doctors’ offices, emergency care clinics and other points of service. We plan to deploy our first batch of instruments to select international clients and the performance data generated will support our long-term commercialization efforts as we build an instrument inventory that we believe will be necessary for our large launch. scale expected in the United States.
About the CE mark
The European Conformity (CE) mark is defined as the mandatory conformity mark of the European Union (EU) to regulate goods sold in the European Economic Area (EEA) since 1985. The CE mark represents a manufacturer’s declaration that the products comply with the new EU approach. Guidelines. These directives apply not only to products within the EU, but also to products manufactured or designed to be sold in the EEA. This makes the CE mark recognizable around the world, even for those unfamiliar with the EEA.
About Quidel Corporation
Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of point-of-care diagnostic solutions, offering a continuum of rapid test technologies that further improve the quality of healthcare around the world. An innovator for more than 40 years in the medical device industry, Quidel launched the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV antigen test. 2 in the United States under a trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac biomarkers and self- immune systems, as well as a multitude 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 and affordable tests for the benefit of our families, communities and the world. For more information on Quidel, visit quidel.com.
This press release contains forward-looking statements within the meaning of federal securities laws that involve important risks, assumptions and uncertainties. Many possible events or factors could affect our future results and performance, so that our actual results and performance may differ materially from those which may be described or implied in forward-looking statements. As such, no forward-looking statement can be guaranteed. Differences in actual results and performance may arise due to a number of factors, including, but not limited to: the impact and duration of the global COVID-19 pandemic; competition from other suppliers of diagnostic products; our ability to accurately forecast demand for our products and developing products, including in new market segments; our ability to develop new technologies, products and markets and to bring new products to market; our reliance on sales of our COVID-19 and influenza diagnostic tests; our dependence on a limited number of key distributors; quantity of our product in the inventory of our distributors or in the distribution channels; changes in the purchasing habits of our distributors; the financial strength of our customers and suppliers; lower than expected market penetration of our products; third party reimbursement policies and potential cost constraints; our ability to meet demand for our products; interruptions, delays or shortages in the supply of raw materials, components and other products and services; failures in our computer and storage systems; our exposure to data corruption, cyber attacks, security breaches and privacy breaches; international risks, including, but not limited to, economic, political and regulatory risks; persistent global political and social uncertainty; our development, acquisition and protection of intellectual property rights; intellectual property risks, including, but not limited to, infringement litigation; loss of emergency use authorizations for our COVID-19 products and failures or delays in receiving regulatory reviews or approvals, clearances or approvals for new or product-related products currently marketed by the United States Food and Drug Administration (“FDA”) or other regulatory authorities or the loss of previously received regulatory approvals, clearances or authorizations or other adverse actions by regulatory authorities; our contracts with government entities involve future risks of financing, compliance and possible sanctions; product defects; changes in government policies and regulations and related compliance risks; our ability to manage our growth strategy and to successfully identify, acquire and integrate acquisition targets or potential technologies and our ability to obtain financing; our acquisition of the Triage® business from Alere presents certain risks to our business and operations; the level of our deferred payment obligations; our exposure to claims and litigation which could result in significant expense and could ultimately result in an adverse outcome for us, including the ongoing litigation between us and Beckman Coulter, Inc .; we may need to raise additional funds to finance our future capital or operating needs; our debt, our deferred and contingent payment obligations; competition and the loss of management and key personnel; business risks not covered by insurance; changes in tax rates and exposure to tax obligations or additional contributions; and the provisions of our constating documents and Delaware law that could delay or impede the actions of shareholders regarding business combinations or similar transactions. Forward-looking statements are generally identified by the use of terms such as “may”, “will”, “should”, “could”, “expect”, “anticipate”, “estimate”, “plan”, ” intend “,” goal “,” project “,” strategy “,” future “and similar words, although certain forward-looking statements are expressed differently. The risks described in the reports and registration statements that we file from time to time with the Securities and Exchange Commission should be carefully considered, including those discussed in point 1A, “Risk Factors” and elsewhere in our annual report. on Form 10K for the fiscal year ended December 31, 2020 and in our subsequent quarterly reports on Form 10 Q. You are urged not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this press release. Except as required by law, we assume no obligation to publish any revision or update of these forward-looking statements, whether as a result of new information, future events or otherwise.