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.
In this overview, we describe different diagnostic assays and explain why they are important for laboratories in various settings. We discuss potential areas for growth in the use of laboratory developed tests, as well as what a laboratory must do to implement one. We also describe more traditional IVD tests that are approved by the U.S. Food and Drug Administration (FDA), the role of IVD tests in the U.S. healthcare system, and some of the potential benefits associated with them. Finally, we review regulations that that must be understood by IVD manufacturers and laboratories that offer LDTs.
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.