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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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Continue your educational journey in diagnostic test implementation
Protecting Intellectual Property for Diagnostic Tests
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.
Webinar Series: Demystifying the Development and Implementation of Molecular Tests in a Clinical Laboratory
Explore the benefits and challenges of bringing an in-house molecular test to market, with real-world examples. In this webinar series, we aim to dispel common misconceptions of laboratory developed tests (LDTs) by inviting industry experts to share about the advantages, design and implementation process, and establishment of LDTs in clinical laboratories.
Using molecular panels to help manage infectious disease: update on lab trends and health outcomes
Learn about the different testing methods used by laboratory managers and the advantages of molecular techniques in areas including respiratory, gastrointestinal, and genitourinary conditions to improve overall outcomes.
