Please click on the button below to read the paper: Regulatory guidance for laboratories that design and implement diagnostic tests for clinical use.
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Patent law directly pertains to the development and commercialization of all diagnostic tests, including LDTs and IVDs. Specifically, patent law is a key consideration during the test lifecycle, and the United States Supreme Court caused a seismic shift in the patenting process for diagnostic tests over the last decade. Although LDTs and IVD tests differ in some respects, the same IP laws and regulations apply equally to both types of in-vitro diagnostics. Read this paper to learn about IP considerations for diagnostic tests.
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