Quidel Corporation engages in the development, manufacturing and marketing of rapid diagnostic testing solutions. The company’s diagnostic testing solutions primarily include applications in infectious diseases, women’s health and gastrointestinal diseases. The company sells its products directly to end users and distributors, in each case, for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, major universities, retail clinics, pharmacies, and wellness screening centers. The company markets its products in the United States through a network of national and regional distributors, and through a direct sales force. Internationally, the company markets primarily through distributor arrangements. The company’s diagnostic solutions aid in the detection and diagnosis of many critical diseases and other medical conditions, including infectious diseases, women’s health, gastrointestinal diseases, autoimmune diseases, bone health and thyroid diseases. Products The company provides diagnostic testing solutions under various brand names, including among others, Quidel, QuickVue, QuickVue+, Sofia, AmpliVue, Solana, Virena, MicroVue, Lyra, FreshCells, D3, FastPoint, ReadyCells, Super E-Mix, ELVIRA, ELVIS and Thyretain. System Platforms—New and In Development The company’s diagnostic testing solutions are provided through various proprietary platforms, including the following platforms recently developed or in development: Fluorescent Immunoassays (FIAs) Sofia Analyzer: Sofia is the brand name for the company’s FIA system. The Sofia Analyzer combines software, when used in conjunction with Sofia FIA tests, to yield an automatic, objective result that is available on the instrument’s screen, in a hard-copy printout, and in a transmissible electronic form that could network through a lab information system to hospital and medical center databases. The Sofia Analyzer provides for different operational modes to accommodate both small and large laboratories, as well as other features designed to facilitate use in various healthcare settings, including hospitals, medical centers, and small clinics. Next Generation Analyzer: The company is developing the next generation Sofia Analyzer with added benefits and features and at a cost point that allows the company to address the lower-volume segment of the diagnostic testing market. Similar to the original Sofia Analyzer, the next generation analyzer is planned to initially center around respiratory assays and then extend into women's health; Lyme disease; and vitamin D tests. Molecular Assays Lyra: The company’s open system molecular assays run on various thermocyclers on the market. The company has various existing Lyra molecular real-time polymerase chain reaction (PCR) assays that provide major benefits to the customer, including among others, room temperature storage, reduced process time, and ready-to-use reagent configurations. AmpliVue: With the company’s Molecular AmpliVue hand-held molecular diagnostic assay platform, the detection of the pathogen is achieved using a hand-held, fully contained cassette that combines isothermal helicase dependent amplification (HDA) with lateral flow detection technology. Solana: The Solana system is developed as an extension to the AmpliVue product line, running the same proprietary HDA technology. Solana is an easy to run amplification and detection system that has the ability to concurrently run approximately 12 assays. With minimal sample preparation for Solana assays, the system has the potential to receive a Clinical Laboratory Improvement Amendments of 1988 waiver. Molecular Systems in Development Savanna: The company is developing the Savanna system as a rugged, low-cost, fully-integrated system with novel extraction, and sample in/result out simplicity. The system is expected to be able to run either PCR or HDA assays from multiple sample types. Connectivity and Data Management Virena: Virena is a wireless cellular instrument management and surveillance system that operates as a cloud based solution connecting Quidel instruments across a healthcare
quidel corp (QDEL:NASDAQ GS)
12544 High Bluff Drive
San Diego, CA 92130
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