The U.S. Food and Drug Administration has announced a July public meeting on the topic of oversight of laboratory-developed tests. The lab test meeting is on July 19-20, 2010, and will feature discussion of how the agency will oversee laboratory-developed tests (LDTs)--in vitro diagnostics manufactured and offered in the same laboratory. These include genetic tests. This announcement comes not long after the the agency sent letters to certain companies manufacturing genetic tests, saying these tests may need premarket approval.

Previously, the agency had not gone to great lengths to exercise enforcement of LDT regulations. The FDA explains in the Federal Register notice that LDTs of the past have been well-understood pathology tests, low-risk diagnostics for rare diseases. However, the FDA points out, in the last 15 years the nature of LDTs has changed to assess high-risk diseases and conditions, as well as genetic tests. The FDA is concerned about the tests' increasing role in clinical decision-making.

In the Federal Register notice the FDA explains, "LDTs are becoming more complex, diagnostic tests are playing an increasingly important role in clinical decision-making and disease management, particularly in the context of personalized medicine. However, LDTs that have not been properly validated for their intended use put patients at risk. Risks include missed diagnosis, wrong diagnosis, and failure to receive appropriate treatment." The agency now feels that a risk-based application of oversight for LDTs is appropriate and to reconsider its policy of enforcement discretion over LDTs.

The two-day meeting will feature an overview of the history and current regulatory status of LDTs, and will be divided into four sessions:
1. Patient Considerations
2. Challenges for Laboratories
3. Direct-to-Consumer Marketing of Testing
4. Education and Outreach

The FDA will collect comments and information during the meeting for later oversight framework. Each session will consist of public presentations focused on each area and will be followed by an expert panel discussion and question-and-answer period.

The public meeting will be held on July 19 and 20, 2010, from 8 a.m. to 5 p.m. at the Crowne Plaza Rockville, Maryland/Washington, D.C. 3 Research Court Rockville, MD 20850. There is no registration fee. Registration can be completed online at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212830.htm#registration. Online registration is available until 5 p.m. on July 12, 2010. People may give public presentations on a first come, first serve basis is they submit a request to do so.

The FDA lab test meeting: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm215766.htm

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