October 2011 Clinical Laboratory News: FDA Says Lab-Developed Test Regulation Will Take Time

AM 2011

The educational offerings at the AACC 2011 Annual Meeting were as diverse as the attendees. Symposia, workshops, brown bag sessions, and more gave attendees the latest information, as well as practical advice, on a myriad of clinical lab topics. Below is a brief on one of the sessions.

FDA Says Lab-Developed Test Regulation Will Take Time

By Bill Malone

Ahead of a long-awaited draft guidance on lab-developed tests (LDTs) from the Food and Drug Administration (FDA) that’s expected soon, agency official Courtney Harper, PhD, assured attendees at AACC’s Annual Meeting that the agency plans a deliberate, methodical approach that will span years to avoid disruptions in testing. “We’re thinking of a very phased-in, long-term approach that will make it feasible for everyone,” said Harper, who is director of the division of chemistry and toxicology devices in FDA’s Center for Devices and Radiological Health. “We have no desire to inundate ourselves with reviewing thousands of tests at once. Neither do we want to delay access to good, new tests.”

FDA announced in July 2010 that the agency was ending its policy of enforcement discretion in regard to LDTs and had decided to forge ahead with a plan to regulate all LDTs. With enforcement discretion, FDA had not required LDTs to be submitted for regulatory review in the same way the commercially marketed test kits go through 510(k) clearance or premarket approval with the agency. At the symposium “Laboratory-Developed Test Regulations: The Alphabet Soup of ASR, LDT, IVD, QA, QC, QSR,” Harper explained that FDA sees a sea-change in how LDTs have been developed and marketed that required closer oversight.

Attendees listened intently as FDA’s Courtney Harper, PhD, 
made the agency’s case for regulation of laboratory-developed tests (LDTs). 
The lab community has been on edge ever since 
FDA announced in 2010 that it planned to regulate all LDTs.

Over the past 20 years, the volume and complexity of LDTs has grown significantly, she said, and LDTs are often now a mechanism for market entry of novel tests without FDA review. FDA is also concerned that LDTs have become a mainstay for commercial labs and biotechnology companies, directly competing with the traditional pathway of test kits that go through FDA. The agency has been especially alarmed over recent years, Harper noted, as faulty data analysis, exaggerated clinical claims, fraudulent data, poor clinical study design, and unacceptable clinical performance in widely marketed LDTs has come to light.

At the same time, Harper acknowledged the confusion and concern labs have expressed over the prospect of LDT regulation, and sought to assuage fears that FDA would quickly ramp up a new, burdensome process for all labs. “Any framework will be risk-based, looking at the intended use of devices and regulating by risk,” she said. “This very phased-in approach would start with high-risk class III devices. Once we got those under control, we would begin to look at more moderate-risk tests. But the expectation is that this approach would not take one or two years—it will likely be more like 15 to 20 years.”

Once FDA releases the draft guidance on LDT regulation, Harper encourages labs to attend agency meetings and submit comments. “We’re going to make sure that this is a very open, transparent process where we hear from all stakeholders,” she said.

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