In ASCO Speech, Hamburg Hints of Change to LDT Regulation

Theral Timpson

Is the FDA going to go through with the much anticipated crack down on LDTs?

In a posting at Forbes, Science and Medicine Reporter, Matthew Herper, quotes FDA Commissioner Hamburg with the following:

“Advanced diagnostics such as these are the cornerstone of personalized medicine, and their development can only foreshadow the many advances on the horizon. This is truly an exciting time in the history of cancer therapies and their companion diagnostics,” Hamburg said. “Unfortunately, not all complex diagnostics used in cancer diagnosis or treatment have been developed to perform at the same demonstrated standards.

“There is a category of diagnostics called laboratory-developed tests which are produced in and offered by laboratories for use in their own facilities. LDTs are currently marketed without FDA premarket review to determine whether they are safe and effective – whether they are accurate and clinically valid. And that can be a problem.”

Herper took these excerpts from a prepared speech Hamburg gave at the American Society for Clinical Oncology in Chicago this week.

As we've covered in our series, Commercializing Diagnostics, there exists an un-level playing field for diagnostics providers in the U.S.   Roche and Qiagen have been leaders in securing FDA approval for their diagnostic tests, only to see clinical labs using non-regulated copies of their tests.  There has been extensive debate about whether LDTs, or laboratory developed tests, done in a CLIA certified lab should require FDA approval as well.  Some, such as representatives from Roche and Qiagen, argue that the non regulated tests are done at lower standards.  Others say that basic quality standards can be maintained by CLIA.  And that the unnecessary burden of regulation will hamper innovation.

“Historically, FDA exercised enforcement discretion – that is, it did not generally enforce applicable regulatory requirements for these devices, because they were relatively simple, low-risk tests performed on a few patients being evaluated by physicians at the same facility as the lab,” Hamburg says. “But LDT’s have become more sophisticated and complex. Results from these tests are rapidly becoming a staple of medical decision-making, particularly for cancer.”

Hamburg's speech this week indicates that the FDA is moving toward a more level playing field.  How far will the FDA go?  Many experts have been expecting the FDA to pursue a stratified rather than a blanket approach, guiding their limited resources toward the most complex, clinically important tests first.

The move could have a big impact on the diagnostics industry.  Many companies, such as CardioDx who we featured last year, have bypassed the FDA and gone on to win reimbursement from the major payers.

There is also an insecurity about the IP value of diagnostics due to the ongoing Myriad Genetics gene patent case. Will diagnostic tests be patentable?  In an upcoming interview at Mendelspod, Mark Trusheim, a Special Government Employee for the FDA's Office of the Commissioner, talks about ways that diagnostics companies can build the value of their tests, other than regulation.  

The diagnostics industry is taking off as we unravel biology and develop new tools, such as next generation sequencers and improved algorithms for finding ever more meaningful biomarkers.  And regulation and patent issues continue to keep the new industry in flux as it attempts to find solid footing.

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