US FDA Looks to Regulate Laboratory-Developed Diagnostic Tests

By Dan Stanton

- Last updated on GMT

Related tags: Regulation, Fda

US FDA Looks to Regulate Laboratory-Developed Diagnostic Tests
The Commissioner of the FDA says laboratory-developed diagnostic tests needs to be regulated for clinical validity to stop erroneous results and ensure patient and clinician confidence.

Laboratory-developed tests (LDTs) are diagnostics which have been produced and offered by laboratories for use within their own facilities. At present such tests are marketed without a regulatory premarket review which has become a concern to the US Food and Drug Administration (FDA).

Speaking at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, the FDA’s Commissioner Dr. Margaret Hamburg said “results from these tests are rapidly becoming a staple of medical decision-making, particularly for cancer.”​ Therefore “the Agency is working to make sure that the accuracy and clinical validity of high-risk tests are established before they come to market.”

In the past she said the FDA had “exercised enforcement discretion”​ due to the tests being relatively simple and low-risk. However, as LDTs become more complex and sophisticated, Hamburg believes there is a need for regulating the diagnostic devices to ensure results are accurate.

One factor that has turned the FDA’s regulatory eyes towards LDTs in recent years was the issues with ovarian cancer screening test ‘OvaSure,’ developed at Yale and marketed by LabCorp. According to the New York times​, when OvaSure came on the market in 2008, the test stirred hope amongst many women of detecting the cancer at an early, treatable stage.

However, the test - which did not undergo clinical validation before use - was flawed, and just months after release LabCorp received a warning letter​ which led to the device being pulled.

“FDA does not know how many women may have received erroneous results from the OvaSure test, or how many may have used that flawed information to make critical medical decisions,”​ said Hamburg.

“Relying on advanced diagnostics to make critical, life-altering treatment decisions exposes patients to obvious risks if these tests do not perform as expected. False results put patients at risk of a missed diagnosis or a wrong diagnosis that could result in either inappropriate treat or no treatment at all.”

The FDA is currently working on a framework to ensure diagnostics used in cancer treatment will provide medical professionals confident and assured tests.

“Our intent in considering what to do about LDTs is to provide for safe and effective diagnostics while promoting innovation and patient access.”

Related topics: Markets & Regulations, Regulations

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