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Genelex Exec: FDA Too Slow to Regulate LDTs

Article-Genelex Exec: FDA Too Slow to Regulate LDTs

Genelex Exec: FDA Too Slow to Regulate LDTs
The company's COO said FDA can't keep up with the pace of innovation in genetic testing and charged that giving the agency domain over laboratory-developed tests will only increase costs.  

Jamie Hartford

An executive at pharmacogenetic testing firm Genelex blasted FDA’s proposal to regulate laboratory-developed tests, saying oversight from the agency will only serve to make personalized medicine more expensive.

“If we have to get genetic technology through the FDA, we’re going to drive the cost of care up substantially as genetic testing becomes more and more prevalent and more and more and more needed,” Kristine Ashcraft, chief operating officer at Genelex, told an audience Monday at the SXSW Interactive conference.

Ashcraft, whose company makes the YouScript Personalized Prescribing System, which combines DNA testing and a medication management system to predict drug-drug and drug-gene interactions, explained that genetic testing is advancing faster than Moore’s Law, which holds that the processing power of computers doubles annually. FDA, she said, simply can’t keep up.

But Ashcraft did admit more oversight is necessary.

“I’m not saying we don’t need a better sheriff in the molecular diagnostics industry, because we do,” she said. “But unless the FDA speeds itself up a lot, they’re not the right ones to do it.”

LDTs, which FDA defines as in vitro diagnostics that are designed, manufactured, and used within a single laboratory, do not currently require premarket approval or clearance by the agency and are instead regulated under the Clinical Laboratory Improvement Amendments (CLIA).

“Granted, CLIA doesn’t do some of the specificity and sensitivity, clinical-utility-type stuff that they’re looking for, but they’re already in our laps,” Ashcraft said.

Asked how LDTs should be overseen, she suggested making accreditation by the College of American Pathologists (CAP) mandatory.

“CAP actually is even more stringent than CLIA,” Ashcraft said. “It’s an option, but maybe in the molecular diagnostics space CAP becomes a requirement and adds an additional layer.”

That, she said, would be a better option than putting LDTs into FDA’s domain.

“I think using the already existing agencies that manage labs rather than trying to toss molecular diagnostics into something that was designed around pharmaceuticals and devices [is preferable],” Ashcraft said.

Jamie Hartford is MD+DI's editor-in-chief. Reach her at [email protected] or on Twitter @medtechjamie.


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