Approval process for laboratory developed tests

Laboratory-Developed Tests (LDT) may be getting an overhaul as hinted at in a “discussion paper” posted by the Food and Drug Administration (FDA). Historically, the FDA has enforced discretion when it comes to these tests. The paper outlines a substantially altered approach but it is in no means a final draft. Instead, it is meant to serve as a conversation starter and a means to communicate the latest thinking at the agency.

The discussion paper indicates that the agency would “grandfather” in the currently marketed LDTs. As far as new LDTs requiring approval, the majority would be moderate to high-risk diseases and the process would be less challenging than previously. The paper also emphasized the importance of transparency during the \ approval process.

The discussion paper also outlined a new and modified approval process for specific categories of LDTs. Unless necessary to protect the public health, they would be exempt from the agencies premarket review, Quality System Regulation (QSR), and registration and listing requirements. Although, the FDA retains its right to enforce any of its regulatory requirements to protect patients from potentially harmful tests.

In a previous statement Margaret Hamburg explains the importance of the FDA’s decision to regulate LDTs, “Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA.” However, with this new proposed plan there would be less extensive regulation, the principle will stay the same.

Although, the FDA has explicitly stated that the discussion paper is by no means a final version and is not in any way a “formal position” of the agency. Taking into consideration the public’s feedback, the FDA will continue to find the best balance between patient safety concerns and oppressive and costly regulations.