Quidel (QDEL) Receives EUA for Moderately Complex Solana® SARS Molecular Test for COVID-19 Diagnosi

Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Solana® SARS-CoV-2 Assay, an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens in viral transport media from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests.

The Solana® 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’s proprietary isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes. The Solana® 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.

Quidel’s Solana® 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® also comes with access to Quidel’s proprietary Virena® data management and surveillance ecosystem, which provides aggregated, de-identified testing data to public health authorities in near real time.

“With so many of our nation’s 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® molecular testing technology,” said Douglas Bryant, president and CEO of Quidel Corporation. “Joining our Lyra® and Lyra® 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® SARS-CoV-2 Assay nicely complements our Sofia® and QuickVue® 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® is a powerful diagnostic solution at a critical time.”

Solana® is an established Quidel brand with more than 1,000 instruments and ten different 510(k) cleared Solana® diagnostic assay applications in the market. In addition to laboratories, Solana® is ideal for use in small- to medium-sized hospitals that cannot afford the space requirements or expense of traditional diagnostic machinery. Solana® 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.

“We 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,” Mr. Bryant added. “Our people have worked around the clock to create these life-saving diagnostic innovations and their ability to speed and scale production has been extraordinary.”

Solana® is a bench top instrument that combines Quidel’s 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®’s simplified workflow also avoids the need for specialized molecular operator training, making Solana easily adoptable in CLIA certified settings.

In addition to the Solana® SARS CoV-2 assay, Quidel’s Solana® 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.

Background Information:

Quidel Corporation operates at the forefront of the battle against the coronavirus pandemic. Quidel received Emergency Use Authorization (EUA) from the FDA for its Lyra® 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® is a leading molecular test for COVID-19.

On 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® SARS Antigen FIA set the bar for antigen test accuracy, proving to be in agreement with PCR results 96.7% of the time.

Quidel developed the first visually read lateral flow flu test, the QuickVue® Influenza A/B Test, which received FDA approval in September of 1999. QuickVue® was also the first flu test cleared by the FDA for use in CLIA-Waived point-of-care facilities like doctors’ offices, urgent care clinics and pharmacies.

QuickVue® 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® units have been sold.

Sofia® 2 is Quidel’s 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® 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data to public health authorities in near real time.

Quidel recently doubled its production of Sofia® 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.

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