Quidel Receives Emergency Authorization for First Rapid Antigen “ABC Test”: A Combination Diagnostic Assay for Influenza A+B and COVID-19
Quidel Corporation (NASDAQ: QDEL) has received Emergency Use Authorization (EUA) from the FDA for its Sofia® 2 Flu + SARS Antigen FIA, a rapid test for detecting SARS-CoV-2 and influenza viruses. This single test provides results in just 15 minutes from a nasal swab, promoting timely and accurate diagnosis. Quidel's test shows a 95.2% positive predictive accuracy for SARS-CoV-2 and significant sensitivity for influenza strains, addressing the challenge of overlapping symptoms during flu season. The company aims to enhance diagnostic speed and accuracy in healthcare settings.
- Received FDA EUA for Sofia® 2 Flu + SARS Antigen FIA, enhancing rapid diagnostics.
- High performance: 95.2% positive predictive accuracy for SARS-CoV-2.
- Results in just 15 minutes, providing timely information to healthcare providers.
- Single swab test for multiple viruses improves efficiency in testing.
- None.
SAN DIEGO--(BUSINESS WIRE)--Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Sofia® 2 Flu + SARS Antigen FIA, a rapid point-of-care test to be used with the Sofia® 2 Fluorescent Immunoassay Analyzer for the rapid, simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
The new Sofia® 2 Flu + SARS Antigen FIA offers excellent performance for SARS-2 (
“As the COVID-19 pandemic converges with seasonal influenza, public health experts face the potential for a ‘perfect storm’ of patients exhibiting similar but distinct medical conditions that require different treatment methods,” said Douglas Bryant, president and CEO of Quidel Corporation. “It is essential for doctors to know what they’re dealing with quickly.”
“This new three-way test to identify and separate influenza strains from coronavirus has arrived just in time for flu season,” said Dr. John Fallon, Medical Director, Vidant Healthcare System. “Quidel has achieved a diagnostic breakthrough that will save time, resources and lives. This is welcome news for healthcare providers already under immense strain from COVID-19 and facing the added challenge of virulent influenza.”
Quidel was the first company to develop an EUA cleared rapid point-of-care antigen test for COVID-19 and remains at the forefront of the battle against COVID-19. The company also developed the first flu test, the QuickVue® Influenza A/B Test, which received FDA approval in September of 1999. With the introduction of its ABC Test, Quidel has registered another first-of-its-kind innovation that packs both its flu and SARS diagnostic technologies onto one highly efficient test cartridge that can be manufactured on the same production lines now used for Sofia® SARS tests. By enabling three tests to be performed simultaneously on a single cartridge using a single swab sample, the company can scale seasonal production of flu tests without impacting its scheduled ramp of COVID-19 antigen test capacity.
While symptoms of flu and COVID are similar, JAMA reports that treatments are different. Even in non-pandemic years, influenza is a serious public health concern. According to a recent report in ScienceAdvances, the flu and other causes of pneumonia are the eighth leading cause of death in the United States.
Mr. Bryant added: “We believe that our new ABC Test (Sofia® 2 Flu + SARS Antigen FIA) will help reduce misdiagnosis, inform proper treatment and improve disease surveillance, significantly enhancing medical effectiveness in fighting COVID-19 and the flu,” Bryant concluded. “We are proud to put this powerful diagnostic tool in the hands of physicians and public health agencies at this critical time.”
Sofia® 2 is Quidel’s best-selling cartridge-based rapid diagnostic system for infectious disease testing, which utilizes fluorescent chemistry design, an intuitive graphical user interface, and optics system to provide a highly accurate, objective and automated result in 15 minutes. The Sofia® 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data in near real-time.
The Sofia® 2 instrument also offers two distinct workflows: depending upon the user’s choice, the Sofia® 2 SARS Antigen FIA cartridge is placed inside Sofia® 2 for automatically timed development (WALK AWAY Mode); or test cartridges can be placed on the counter or bench top for a manually timed development and then placed into Sofia® 2 to be scanned (READ NOW Mode), allowing the user to markedly increase testing throughput per hour.
The Sofia® 2 Flu + SARS Antigen FIA is currently available for sale in the United States under EUA, and Quidel is now shipping the product to its customers. Quidel also offers the Sofia® SARS Antigen FIA under EUA as well as several other Sofia® assays, which are FDA cleared and CLIA waived, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 15-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofia® tests for Lyme Disease, Legionella and S. pneumoniae in Europe.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, COVID-19, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future financial results and performance, such that our actual results and performance may differ materially from those that may be described or implied in the forward-looking statements. As such, no forward-looking statement can be guaranteed. Differences in actual results and performance may arise as a result of a number of factors including, without limitation: the impact of the novel virus (COVID-19) global pandemic; an inability to meet key deliverables and milestones under the NIH’s RADx-ATP contract; adverse changes in competitive conditions, the reimbursement system currently in place and future changes to that system, changes in economic conditions in our domestic and international markets, lower than anticipated market penetration of our products, our reliance on sales of our influenza and COVID-19 diagnostic tests, fluctuations in our operating results resulting from the timing of the onset, length and severity of cold and flu seasons, seasonality, government and media attention focused on influenza and other respiratory or novel viruses and the related potential impact on humans from such viruses, the quantity of our product in our distributors’ inventory or distribution channels, changes in the buying patterns of our distributors, and changes in the healthcare market and consolidation of our customer base; our development, acquisition and protection of proprietary technology rights; our development of new technologies, products and markets; our reliance on a limited number of key distributors; our exposure to claims and litigation that could result in significant expenses and could ultimately result in an unfavorable outcome for us, including the ongoing litigation between us and Beckman Coulter, Inc.; intellectual property risks, including but not limited to, infringement litigation; our need for additional funds to finance our capital or operating needs; the financial soundness of our customers and suppliers; acceptance of our products among physicians and other healthcare providers; competition with other providers of diagnostic products; failures or delays in receipt of new product reviews or related to currently-marketed products by the U.S. Food and Drug Administration (the “FDA”) or other regulatory authorities or loss of any previously received regulatory approvals or clearances or other adverse actions by regulatory authorities; changes in government policies; costs of and adverse operational impact from failure to comply with government regulations in addition to FDA regulations; compliance with government regulations relating to the handling, storage and disposal of hazardous substances; third-party reimbursement policies and potential cost constraints; our failure to comply with laws and regulations relating to billing and payment for healthcare services; our ability to meet demand for our products; interruptions or shortages in our supply of raw materials and other components; product defects; business risks not covered by insurance; costs and disruptions from failures in our information technology and storage systems; our exposure to data corruption, cyber-based attacks, security breaches and privacy violations; competition for and loss of management and key personnel; international risks, including but not limited to, compliance with product registration requirements, compliance with legal requirements, tariffs, exposure to currency exchange fluctuations and foreign currency exchange risk, longer payment cycles, lower selling prices and greater difficulty in collecting accounts receivable, reduced protection of intellectual property rights, social, political and economic instability, increased financial accounting and reporting burdens and complexities, taxes, and diversion of lower priced international products into U.S. markets; changes in tax rates and exposure to additional tax liabilities or assessments; risks relating to our acquisition and integration of the Triage MeterPro Cardiovascular and toxicology business and B-type Natriuretic Peptide assay business; that we may have to write off goodwill relating to our acquisitions; our ability to manage our growth strategy and identify and integrate acquired companies or technologies and our ability to obtain financing; the level of our indebtedness and deferred payment obligations; our ability to generate sufficient cash to meet our debt service and deferred and contingent payment obligations; that our Revolving Credit Facility is secured by substantially all of our assets; the agreements for our indebtedness place operating and financial restrictions on us and our ability to operate our business; that an event of default could trigger acceleration of our outstanding indebtedness; that we may incur additional indebtedness; increases in interest rate relating to our variable rate debt; dilution resulting from future sales of our equity; volatility in our stock price; provisions in our charter documents, Delaware law and the indenture governing our Convertible Senior Notes that might delay or impede stockholder actions with respect to business combinations or similar transactions; our intention of not paying dividends; and our ability to identify and successfully acquire and integrate potential acquisition targets. Forward looking statements typically are identified by the use of terms such as “may,” “will,” “should,” “might,” “expect,” “anticipate,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” and similar words, although some forward-looking statements are expressed differently. The risks described in reports and registration statements that we file with the Securities and Exchange Commission (the “SEC”) from time to time, should be carefully considered. You are cautioned 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 undertake no obligation to publicly release the results of any revision or update of these forward-looking statements, whether as a result of new information, future events or otherwise.
