Vistatec Life Sciences — In Focus Panel Discussion on Laboratory Developed Tests
The recent Life Sciences – In Focus Panel brought together leading regulatory experts to discuss a hot topic in the diagnostics industry: Laboratory Developed Tests (LDTs) and their tumultuous regulatory journey. Hosted by Karen Tkaczyk, Director of Sales at Vistatec Life Sciences, the panel featured Cortez McBerry (Regulatory Consulting Director at NDA Partners), Sean McCarthy (Senior Regulatory Manager at Enhanced Compliance, Inc.), and Tristin Wolff Cope (Director of Regulatory Compliance at Biodesix). Their insights not only unraveled the complexities of LDT oversight but also emphasized the pressing need to bridge gaps in regulatory frameworks.
What Are LDTs?
Tristin Wolff Cope speaks on Laboratory Developed Tests. LDTs are diagnostic tests that are designed, manufactured, and used within a single laboratory. Unlike In Vitro Diagnostics (IVDs), LDTs aren’t distributed commercially and have historically been regulated under the Clinical Laboratory Improvement Amendments (CLIA) rather than the FDA.
However, as Tristin pointed out, the lines have blurred, especially as technology and software have revolutionized diagnostics. “The FDA’s final rule would have shifted LDTs from a CMS-regulated space to full FDA oversight,” she explained. But that move was challenged and ultimately vacated in court, leaving labs and manufacturers in regulatory limbo.
The Legal Landscape
Sean McCarthy highlighted the challenge: “The recent court decision that vacated the FDA’s final rule on LDTs means that enforcement discretion remains in place. But that doesn’t mean the risk is gone. Labs and manufacturers must still navigate a patchwork of regulatory expectations.”
He elaborated on the gray area: “FDA may still enforce regulations around specimen collection devices and software, areas with clear risk. And with new technologies like AI, the lines get even more complicated. For instance, labs that rely on Research Use Only (RUO) reagents face scrutiny over whether those products are being used appropriately in clinical settings.”
Cortez McBerry added that FDA inspection of labs continues, especially for those with 510(k) clearances or PMAs, further muddying the waters for labs that consider themselves LDT developers but distribute devices or software beyond their facilities.
“Labs need to ask themselves: Are they truly developing and running tests solely in-house, or are they drifting into commercial device territory?”
Insights from the Frontlines
The experts emphasized the importance of robust quality systems, regardless of whether FDA oversight is currently required. “Labs should think about implementing design controls, robust validation, and documentation now,” Cortez advised. “It’s not just about regulatory compliance; it’s about patient safety and test reliability.”
Tristin underscored the complexity of the landscape: “In New York State, for example, CLEP approval requires extensive analytical and clinical validation, and labs operating there might feel prepared. But smaller labs or those in other states may find the shift to FDA regulation daunting.”
Sean agreed, cautioning that even with enforcement discretion, the FDA could step in after a safety incident or a complaint. “Labs might think they’re safe until a problem occurs. That’s why risk management is critical: classifying tests accurately, ensuring robust documentation, and consulting with regulatory experts.”
Global Perspectives and Future Readiness
While the conversation focused on the US, the panel also touched on global harmonization. “Other jurisdictions, like the EU and Japan, have their own frameworks,” Sean noted. “Manufacturers aiming for international markets must understand different classification schemes and risk-based pathways.”
Cortez reminded the audience that the US is moving toward ISO 13485 alignment by 2026, which could streamline some processes and raise the bar for quality management.
Key Takeaways
- LDTs remain a regulatory gray zone: FDA’s final rule was vacated, but enforcement discretion is still in place. Labs must stay vigilant about potential regulatory triggers, especially around software, specimen collection kits, and RUO reagents.
- Quality systems matter: Even with FDA requirements, robust quality management is key to ensuring patient safety and long-term viability.
- Global harmonization is coming: ISO 13485 adoption in the US and divergent pathways abroad require manufacturers to think globally.
- Seek expert guidance: Navigating LDT regulations, especially with evolving technologies like AI, requires collaboration with experienced regulatory professionals.
Summary
Karen Tkaczyk summed up the event perfectly: “This discussion shows that while the regulatory landscape is uncertain, the commitment to patient safety and innovation must remain at the forefront. Let’s use this time to build stronger systems and collaborate for better outcomes.”
About Life Sciences – In Focus
Life Sciences – In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences – In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences – In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.
About Vistatec
We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com