Regulatory clarity fromthoughttofinish
LDT Resources
For decades, Laboratory Developed Tests (LDTs) have been subject to little regulatory oversight compared to in vitro diagnostic tests (IVDs), allowing laboratories to develop and run these tests unencumbered by FDA regulatory requirements. As LDTs have become increasingly sophisticated and commercially widespread, the FDA has moved to regulate them, applying the same regulatory requirements to LDTs and IVDs.
Stay ahead of the evolving LDT landscape with ELIQUENT’s LDT Resource Hub. You’ll find expert-driven content, insights, and practical guidance from our team of LDT experts. Explore our resources and gain the clarity you need to move forward with confidence.
Ready to enhance your LDT knowledge?
ELIQUENT’s LDT resources provide in-depth analysis, actionable strategies, and real-world examples from industry experts. Whether you’re adapting to new regulations, optimizing quality systems, or exploring emerging technologies, our resources keep you ahead of the curve.
MicroLearnings
Short on time? ELIQUENT’s LDT MicroLearnings are designed to deliver key information in a quick, engaging, and easily digestible format. These short, high-impact lessons are perfect for busy professionals who need relevant, practical insights without the time commitment of traditional training.
Explore our LDT MicroLearning and build your expertise, one lesson at a time!
Laboratory-Developed Tests (LDTs):
How Did We Get Here?
The regulation of Lab-Developed Tests (LDTs) has been debated for decades. What role has the Centers for Medicare & Medicaid Services (CMS) played?
In this short video, we explore:
• The history of LDT oversight
• Key policy shifts and regulatory gaps
• What the CMS has done (and not done) to regulate LDTs
Watch now to understand how we got here — and where we’re headed.
What’s your take on the CMS’s role in LDT regulation?
These videos are for your viewing only via this website and are not to be reproduced or distributed. No license rights are granted. *
LDT Solutions
As the LDT landscape continues to evolve, a trusted partner is crucial to stay ahead of regulatory challenges. ELIQUENT Life Sciences is uniquely positioned to support laboratories during this critical transformation. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists partners with LDT companies to maintain compliance, ensure product quality, and remain competitive in an evolving regulatory landscape.
Learn more about ELIQUENT’s LDT Solutions.