A New Era for LDTs: Innovation Without Overregulation

In landmark news, the FDA’s 60-day window for appeal has expired, meaning that the FDA’s final rule on Laboratory-Developed Tests (LDTs) is officially and completely vacated. So what does this mean for molecular laboratories, diagnostics companies, and patients?

For one, it means that they are breathing a collective sigh of relief—and looking ahead with renewed energy. In a recent interview with MD+DI, Greer Massey, PhD, Chief Scientific Officer of Molecular Designs, and Shawn Hood, President of Streamline Scientific give their takes on the pulse of the molecular diagnostics community in reaction to the news. 

An Avoided Burden

When the FDA initially published its final rule regarding the governance of LDTs, its appropriateness was hotly debated given the long-standing regulatory frameworks mandated by CLIA and COLA. But the concerns were more encompassing than just a redundant layer of regulations—the FDA’s attempt to regulate LDTs as in vitro diagnostics could have meant:

• Delayed test development due to lengthy approval timelines
• Reduced flexibility in adapting to new or emerging pathogens
• Skyrocketing costs that would strain innovation and patient access

Now, the legal pronouncement is clear: the FDA’s new approach to LDTs was an overreach of its statutory authority.

Industry Leaders On Where We Go From Here

Greer Massey reflects on implications for the industry. “Creativity has been opened for all scientists,” said Massey. “Where we can now look at the future where we’ve recently been in a holding pattern.”

Shawn Hood goes on to detail Streamline Scientific’s pivot since the announcement: moving away from investing time and resources into planning for the rule and towards helping labs design, validate, and launch.

In the interview, Massey and Hood dive into how reversing the decision is likely to have positive impacts broadly across the molecular diagnostics space:

• Infectious disease LDTs will maintain the ability to respond rapidly to local outbreaks and 
  emerging pathogens.
• Less regulatory burden means lower costs for the overall system, which ensures 
  a continuation in the current level of accessibility. 
• Avoiding FDA oversight creates more dependability in LDT development timelines

What’s Next for Molecular Designs & Streamline Scientific?

With final rule behind Hood and Massey, they’re looking to the future with optimism:

Molecular Designs will continue to build high-quality PCR research-use assays that can be used to support laboratory-developed testing. This will run alongside efforts to bring formal, FDA-cleared IVD testing to market.

Streamline Scientific is proud to support the hundreds of labs already relying on their consulting team while equipping hundreds more to launch new assays through fast, efficient validations, unencumbered by excessive regulations.

Read the Full Story

To dive deeper into how the FDA’s withdrawal impacts labs, and hear more from Greer Massey and Shawn Hood, read the full article on MD+DI.