In the meantime, please explore these related resources:
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.
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.
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.