Quidel Corporation


Quidel Corporation is a major American manufacturer of diagnostic healthcare products that are sold worldwide.
On May 8, 2020 the U.S. Food and Drug Administration has issued the first emergency use authorization for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs.

History

Quidel commenced operations in 1979 and launched its first products in 1984. Quidel Corporation was formed in 1991 when Quidel and Monoclonal Antibodies merged.
On June 18, 1997 Quidel settled a lawsuit with Becton Dickinson. Quidel had been accused of infringing patents on Becton's strep and chlamydia products. Quidel agreed to buy a product license and pay royalties on its product sales.
In February 2004, Inverness Medical Innovations sued Quidel for patent infringement. That same month, Quidel countersued against Inverness.
In May 2020, Quidel’s Sofia 2 SARS Antigen FIA has become the first COVID-19 antigen test to be granted Emergency Use Authorization by the FDA.

Expertise

Since its merger, Quidel has expanded its product base through internal development and acquisition with a focus on increasing its research and development efforts to accelerate the rate of new product introductions.
Quidel's core competencies and capabilities include immunoassay development, automated manufacturing, monoclonal antibody characterization and development, and molecular assay development.

Products

Quidel's current products fall generally into these categories: lateral flow, where it focuses on infectious disease and reproductive health; direct fluorescent antibodies, with expertise in infectious disease and virology; micro-titer production, with a focus on bone and complement pathway markets; fluorescent immunoassay products ; and molecular diagnostic products.
These products include assays such as QuickVue, Thyretain and the new Sofia and AmpliVue brands, which focus on diagnosing influenza, thyroid disease, and many other diseases, and can improve the healthcare quality of hospitals.
During 2011, the US Food and Drug Administration and the European Conformity Mark provided Quidel with 510 clearance for selling Sofia Analyzer, and another 510 clearance for the Quidel Molecular hMPV Assay.

Acquisition

In 1999, Quidel acquired Metra Biosystems, Inc.to participate in bone health assessment. In 2000, Quidel acquired Litmus Concepts, Inc., a privately held in vitro diagnostic company.
In 2010, Quidel acquired Diagnostic Hybrids, Inc. a privately held in vitro diagnostic company. In 2013, Quidel acquired BioHelix Corporation, established in 2004, and was to pay $10 million to the BioHelix shareholders.