\nThe Solana\u00ae SARS CoV-2 offers a number of advantages over competing laboratory-based molecular diagnostic test protocols for COVID-19, including: a simple workflow with no sample extraction; a medium volume throughput design that is ideal for batch testing and improved laboratory efficiency; and a fast, 25-minute run time for up to 11 samples. The assay consists of two main steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to SARS-CoV-2 using Quidel\u2019s proprietary isothermal Reverse Transcriptase \u2013 Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes. The Solana\u00ae instrument objectively measures and interprets a fluorescent signal, reports the test results to the user on its display screen, and can print out the results via an integrated printer.\n<\/p>\n
\nQuidel\u2019s Solana\u00ae bench-top instrument is designed for maximum space efficiency and ease of use. The small-profile instrument features an interactive touchscreen and barcode scanner for easy data entry, Ethernet and USB ports for data transfer and printing and compatibility with Dymo Label Writer systems. Solana\u00ae also comes with access to Quidel\u2019s proprietary Virena\u00ae data management and surveillance ecosystem, which provides aggregated, de-identified testing data to public health authorities in near real time.\n<\/p>\n
\n\u201cWith so many of our nation\u2019s laboratories overwhelmed by demand for COVID-19 tests and under pressure to produce more timely results, there is a compelling societal need for the throughput and quick runtime offered by our new Solana\u00ae molecular testing technology,\u201d said Douglas Bryant, president and CEO of Quidel Corporation. \u201cJoining our Lyra\u00ae and Lyra\u00ae Direct assays for SARS-CoV-2, we now offer another molecular weapon in the fight against COVID-19 to quickly diagnose symptomatic patient populations. The Solana\u00ae SARS-CoV-2 Assay nicely complements our Sofia\u00ae and QuickVue\u00ae tests that are run at the point-of-care, for pre-symptomatic, asymptomatic and symptomatic patients. We are pleased to bring the benefits of our proprietary RT-HDA technology to detect COVID-19 to the marketplace and further democratize access to testing across the country. Solana\u00ae is a powerful diagnostic solution at a critical time.\u201d\n<\/p>\n
\nSolana\u00ae is an established Quidel brand with more than 1,000 instruments and ten different 510(k) cleared Solana\u00ae diagnostic assay applications in the market. In addition to laboratories, Solana\u00ae is ideal for use in small- to medium-sized hospitals that cannot afford the space requirements or expense of traditional diagnostic machinery. Solana\u00ae also eliminates the need for healthcare facilities to send patient test samples out for processing — saving time and costs while reducing the backlog at central laboratories.\n<\/p>\n
\n\u201cWe are proud of the commitment demonstrated by our Quidel team since the first day we started developing our PCR, rapid antigen and HDA tests for COVID-19,\u201d Mr. Bryant added. \u201cOur people have worked around the clock to create these life-saving diagnostic innovations and their ability to speed and scale production has been extraordinary.\u201d\n<\/p>\n
\nSolana\u00ae is a bench top instrument that combines Quidel\u2019s proprietary helicase-dependent amplification (HDA) with fluorescence detection to deliver molecular results faster than ever before. Isothermal amplification eliminates thermal cycling, operating at one temperature in one tube to reduce the time to result to as little as 25 minutes. Solana\u00ae\u2019s simplified workflow also avoids the need for specialized molecular operator training, making Solana easily adoptable in CLIA certified settings.\n<\/p>\n
\nIn addition to the Solana\u00ae SARS CoV-2 assay, Quidel\u2019s Solana\u00ae instrument can run a suite of diagnostic assays and panels including Bordetella, C. Difficile, GAS, GBS, HSV 1+2\/VSV, Influenza A+B, Respiratory Viral Panel, RSV + hMPV, Strep, and Trichomonas.\n<\/p>\n
Background Information: <\/b><\/p>\n
\nQuidel Corporation operates at the forefront of the battle against the coronavirus pandemic. Quidel received Emergency Use Authorization (EUA) from the FDA for its Lyra\u00ae SARS-CoV-2 Assay, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from COVID-19 on March 17, 2020. Lyra\u00ae is a leading molecular test for COVID-19.\n<\/p>\n
\nOn May 8, 2020, Quidel was first to market in the U.S. with a rapid antigen test that delivers results in 15 minutes. Quidel’s Sofia\u00ae SARS Antigen FIA set the bar for antigen test accuracy, proving to be in agreement with PCR results 96.7% of the time.\n<\/p>\n
\nQuidel developed the first visually read lateral flow flu test, the QuickVue\u00ae Influenza A\/B Test, which received FDA approval in September of 1999. QuickVue\u00ae was also the first flu test cleared by the FDA for use in CLIA-Waived point-of-care facilities like doctors\u2019 offices, urgent care clinics and pharmacies.\n<\/p>\n
\nQuickVue\u00ae is a market leading platform for visually diagnosing Influenza, respiratory syncytial virus (RSV), Strep A and a variety of other illnesses. Since its FDA approval in 1999, more than 150 million QuickVue\u00ae units have been sold.\n<\/p>\n
\nSofia\u00ae 2 is Quidel\u2019s best-selling cartridge-based, instrument read 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\u00ae 2 system also comes connected to Virena\u00ae, Quidel\u2019s data management system, which provides aggregated, de-identified testing data to public health authorities in near real time.\n<\/p>\n
\nQuidel recently doubled its production of Sofia\u00ae rapid antigen tests to the current rate of approximately two million tests per week. The company is building additional production lines that we expect will more than double current capacity once again. Our goal is to reach a run-rate of over 240 million tests per year by the third quarter of 2021.\n<\/p>\n
About Quidel Corporation<\/b><\/p>\n
Quidel Corporation<\/b> (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\u00ae, Solana\u00ae, Lyra\u00ae, Triage\u00ae and QuickVue\u00ae, Quidel\u2019s 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\u2019s 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. For more information about Quidel, visit quidel.com<\/a><\/b>.\n<\/p>\n Forward-Looking Statements<\/b><\/p>\n 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 and duration of the novel virus (COVID-19) global pandemic; funding and compliance risks relating to government contracts, including our ability to meet key deliverables and milestones under our NIH RADx-ATP contract; our ability to accurately forecast demand for our products and products in development, including in new market segments; 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, our ability to meet demand for our products; interruptions or shortages in our supply of raw materials and other components; the quantity of our product in our distributors\u2019 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 ability to develop new technologies, products and markets and to commercialize new products; 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 ability 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 from 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 \u201cFDA\u201d) 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; 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; our ability to manage our growth strategy and successfully identify, acquire and integrate potential acquisition targets or technologies and our ability to obtain financing; the level of our deferred payment obligations; that our Revolving Credit Facility is secured by substantially all of our assets; operating and financial restrictions on us under the agreements for our indebtedness and their effect on our ability to operate our business; that an event of default could trigger acceleration of outstanding indebtedness; that we may incur additional indebtedness; dilution resulting from future sales of our equity; volatility in our stock price; provisions in our charter documents and Delaware law that might delay or impede stockholder actions with respect to business combinations or similar transactions; and our intention of not paying dividends. Forward-looking statements typically are identified by the use of terms such as \u201cmay,\u201d \u201cwill,\u201d \u201cshould,\u201d \u201cmight,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cestimate,\u201d \u201cplan,\u201d \u201cintend,\u201d \u201cgoal,\u201d \u201cproject,\u201d \u201cstrategy,\u201d \u201cfuture,\u201d 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 from time to time, should be carefully considered. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management\u2019s analysis only as of the date of this press release. Except as required by law, we undertake no obligation to publicly release any revision or update of these forward-looking statements, whether as a result of new information, future events or otherwise.<\/i><\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20201223005469\/en\/<\/a><\/span><\/p>\n \nQuidel Contact: \nMedia and Investors Contact: KEYWORDS:<\/b> United States North America California<\/p>\n INDUSTRY KEYWORDS:<\/b> Data Management Health FDA Infectious Diseases Technology Software Biotechnology<\/p>\n<\/p>\n
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Quidel Corporation
\n
Randy Steward
\n
Chief Financial Officer
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(858) 552-7931\n<\/p>\n
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Quidel Corporation
\n
Ruben Argueta
\n
(858) 646-8023
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rargueta@quidel.com<\/a><\/p>\n
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