Clinical labs worry proposed FDA rules may force tough choices

Sarah CP Williams

Nature Medicine

20,

973

(2014)

doi:10.1038/nm0914-973

Published online: 04 September 2014

At ARUP Laboratories in Salt Lake City, pathologists and clinical chemists receive tens of thousands of blood, urine and biopsy samples every day. Some come from the nearby University of Utah, which owns the not-for-profit lab, whereas others come from government agencies, large teaching hospitals or small clinics around the country. All of these clients have one thing in common: they rely on ARUP to perform clinical tests that they rarely use and so don't provide at their own facility. ARUP offers more than 3,000 different tests, and hundreds of them are carried out using protocols that the lab has created itself and then fine-tuned over many years. These lab-developed tests, as they're called—because they don't pass hands between a company that develops them and a lab that purchases and uses them—have never before been regulated by the US Food and Drug Administration (FDA). That's about to change.

In response to the proliferation of lab-developed tests, which are increasingly marketed to consumers, the FDA notified the US Congress on 31 July that it plans to issue guidance on the regulation of such tests. At the same time, the agency published a Draft Framework Guidance outlining how the regulation would be carried out. The official proposal won't be open for public comment until the end of September, and it will likely be years before the regulation is finalized and then fully implemented. But laboratories like ARUP are already worried about how it will affect business—and patient care.

“The concern is that if we have hundreds of tests falling into this new framework, we have to start making decisions on which we do the work for first, and which we put off,” says Mark Astill, vice president of research and development at ARUP. “We'll spend a lot more time revisiting the medicine we've already been practicing rather than addressing new technologies.” Even if there is a five-year window to complete the trials and paperwork necessary for the new approval, Astill says it will take time and money away from normal operations. And this could be reflected in the cost of the tests.