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Quest Diagnostics Incorporated is an American clinical laboratory. A Fortune 500 company, Quest operates in the United States , Puerto Rico , Mexico , and Brazil . [ 3 ] Quest also maintains collaborative agreements with various hospitals and clinics across the globe.
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Laboratory Corporation of America Holdings (Labcorp), headquartered in Burlington, North Carolina, provides laboratory services used for diagnosis and healthcare decisions. [1] It operates one of the largest clinical laboratory networks in the world and has operations in over 100 countries; although its operations are primarily in the U.S. [ 1 ]
Clinical laboratory services includes large multinational corporations such LabCorp, Quest Diagnostics, and Sonic Healthcare [23] but a significant portion of revenue, estimated at 60% in the United States, is generated by hospital labs. [24] In 2018, the total global revenue for these companies was estimated to reach $146 billion by 2024. [25]
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Under the CLIA, it is the role of the FDA to assess the complexity of the in vitro laboratory diagnostic tests. [33] Tests are only scored after the FDA has cleared or approved a premarketing request, or upon request. [36] Manufacturers can apply for CLIA waivers during this premarket approval/clearance process.
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