Bio Break: Laboratory Developed Tests vs. In Vitro Diagnostics

Resources

Bio Break: Laboratory Developed Tests vs. In Vitro Diagnostics

Sector: Diagnostics
Topic: Bio Break

In this episode of Bio Break, Joris van der Heijden and Nick Allan dive into the FDA’s new regulations surrounding Laboratory Developed Tests (LDTs) and their impact on the medical device industry. As LDTs grow in complexity, including applications like genetic testing and AI-driven diagnostics, these regulatory changes mark a significant shift for laboratories, developers, and healthcare providers.

Nick, drawing on his experience with medical device development, explains the critical distinctions between LDTs and In Vitro Diagnostics (IVDs). He provides insights into why these changes are happening and what they mean for developers working to bring innovative diagnostic tools to market.

Key takeaways from the episode include:

  • Understanding the Difference: LDTs are clinically validated tests performed in CLIA-approved labs but do not require FDA regulatory clearance, unlike IVDs, which are classified as medical devices.
  • The Shift in Regulation: The FDA is transitioning from selective enforcement to increased scrutiny due to the growing complexity and impact of LDTs, such as cancer diagnostics and genetic testing.
  • Implications for Developers: Nick explores how the new regulations add layers of oversight but also improve the safety, accuracy, and reliability of tests with far-reaching implications for patient care.

Joris and Nick discuss the broader industry impacts, including the challenges and opportunities presented by these regulatory changes. While some pushback is expected, they highlight how these steps are ultimately beneficial for innovation and patient outcomes, ensuring that advanced diagnostics meet higher standards of clinical utility and reliability.

This episode is essential viewing for medical device developers, diagnostic innovators, and healthcare professionals navigating the evolving regulatory landscape. Gain a clear understanding of how the FDA’s increased involvement in LDTs is shaping the future of diagnostics and how to stay ahead in this rapidly changing environment.

Laboratory Developed Tests vs. In Vitro Diagnostics

YouTube video thumbnail

Read our article on the impact of FDA Laboratory Developed Tests 2024 Policy update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). 

A fluorescent protein assay sample glows under UV light as part of medical device cleaning validation testing.

Fluorescent Protein Assay Testing in Medical Devices

Nick Allan and Nigel Syrotuck explain how a fluorescent protein assay helps engineers measure contamination and cleaning performance in medical devices.

Engineer assembling electronic components during medical device design transfer process.

Bridging the Design-to-Manufacturing Gap in Medical Devices

Your team is ready for design validation. The prototype performs well, test plans are in motion, and everything points to a smooth handoff to manufacturing. Then your partner calls with bad news: they can’t build the device as designed.

Contract Manufacturer Rejection - Engineering team reviews early-stage medical device design and manufacturability during a design transfer meeting at StarFish Medical.

When the CM Says No: What to Do When Your Contract Manufacturer Rejects Your Early-Stage Build

You’ve cleared the toughest engineering hurdles and proven your design works. Then, just as you prepare to scale, your contract manufacturer turns you down.

Black cubes with white arrows changing direction, symbolizing strategic pivots and disciplined commercialization in MedTech exit optimization.

Exit Optimization: Building Strategic Optionality

In Medtech, a successful exit isn’t just about having an innovative device, it’s about building a business that potential buyers and investors can clearly see a future in.