The End of the LDT Battle

In quite a significant moment for the entire clinical laboratory field, the 60-day window for the FDA to appeal a court ruling on laboratory-developed tests (LDTs) has officially closed. The ruling, issued by Judge Sean Jordan on March 31, said the FDA does not have the legal authority to regulate LDTs. Since no appeal was filed, it seems Health and Human Services Secretary, Robert Kennedy, chose not to challenge the decision – potentially bringing this long regulatory debate to an end.

Many in the lab and pathology community welcome this outcome. However, some diagnostic companies supported FDA oversight, arguing that all tests – whether sold as kits or services – should follow the same rules to ensure a level playing field.

In a recent article for The Pathologist, Caitlin Raymond, recently graduated clinical pathology resident and current transfusion medicine fellow, wrote the following about the court decision against FDA regulated LDTs:

“We lost a national framework for standardization. We lost an opportunity to formalize quality benchmarks across platforms and institutions, with external assurance that we are doing the best for our patients. We lost a potential lever for aligning diagnostics with the broader culture of patient safety that governs other medical devices and therapeutics.

And perhaps most dangerously, we risk reinforcing the idea that autonomy and accountability are mutually exclusive.”

I think Dr Raymond would be served to gain a better real world perspective on how government regulation, current and proposed, significantly impacts the clinical laboratory and the development of new diagnostic modalities. It’s also important to understand the long, complex history behind the proposed regulations for LDTs.

This debate isn’t really about “standardization” or “benchmarks” – those are already addressed under CLIA rules, which gradually tighten accuracy requirements as technology improves. For example, testing for hemoglobin A1c and PSA levels has become more reliable over time. Admittedly some improvement in the effectiveness of the CLIA framework may be advisable, and there have already been calls for such in the wake of the court decision striking down FDA regulation.

The FDA’s version of LDT regulation would have shifted control over new diagnostic tests to the government, requiring labs to go through a costly and time-consuming approval process – something only large companies could afford.

The push for these regulations (and the rejected VALID Act that preceded) was driven by heavy lobbying from patient advocacy groups after one problematic case in 2008, when LabCorp launched an ovarian cancer test called “OvaSure,” developed at Yale. The test overestimated cancer risk and was pulled within months after doctors raised concerns. While this was unfortunate, it’s unclear whether FDA oversight would have prevented it. The problem likely stemmed from the population used for validation studies not being entirely analogous to the population actually screened – a mistake that’s hard to predict in advance.

Oversight of test accuracy is best managed under CLIA, not the FDA. Adding another layer of regulation could stifle innovation – especially for smaller labs. Historically, independent labs have driven major advances in diagnostics. One famous example is Rosalyn Yalow, who developed the first modern immunoassay in a small Veteran Affairs hospital lab in the Bronx, eventually earning the Nobel Prize. Making it harder for smaller labs to innovate would not serve public interest.

Stephen Apfelroth is Director of Laboratories and Vice-Chair of Pathology, Jacobi Medical Center, Board of Directors Physician Affiliate Group of New York, US