Quidel to Update Packaging of Point-of-Care Sofia® SARS Antigen Test for COVID-19 to Include Either Nasal or Nasopharyngeal Swabs

Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that labeling for Quidel’s Emergency Use Authorization (EUA) for the Sofia® SARS Antigen FIA has been amended to include either nasal or nasopharyngeal swabs.

The new kit labeling, with the addition of a nasopharyngeal swab, allows Quidel to offer a second kit configuration to support the nasopharyngeal sample commonly performed in hospitals and helps alleviate some of the supply chain constraints around nasal swab-based kits. Quidel’s Sofia® SARS Antigen FIA has always been authorized for use with either nasal or nasopharyngeal swabs specimens. Due to customer preference, the Sofia SARS Antigen kit has been sold only with a nasal swab. A new kit configuration including nasopharyngeal swabs allows Quidel to increase its weekly delivery of the Sofia Antigen test.

“In our quest to do the most good during the novel coronavirus pandemic, offering our hospital customers another kit configuration with an NP collection device option allows us to work through some of the near-term nasal swab shortages we face to be able to ship more Sofia® SARS Antigen FIA kits and thereby enable more patients to be tested,” said Douglas Bryant, president and CEO of Quidel Corporation. “We strongly believe that frequent testing using an accurate point-of-care antigen test allows for more successful implementation of contact tracing and self-isolation programs, which are key to help reduce the spread of COVID-19.”

Quidel currently sells the Sofia® SARS Antigen FIA in the United States under Emergency Use Authorization (EUA) by the FDA.

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 agree on a definitive agreement or 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 other respiratory or novel virus 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; 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