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AACR Urges FDA to Regulate High-Risk LDTs

NEW YORK (GenomeWeb) – The American Association for Cancer Research today urged the US Food and Drug Administration to start actively regulating "high risk" lab developed tests that doctors are using to make decisions about how to treat their cancer patients.

In addition, the association's immediate past president Charles Sawyers was scheduled to provide testimony in a hearing being held today by a House of Representatives committee to provide Congress with a better picture of how LDTs are being used and the regulatory structures that affect them.

In a policy statement issued by AACR today, the group said it is "imperative" that all diagnostic tests being used to make treatment decisions, including those companion diagnostic tests used to tailor individual cancer therapies, be approved by FDA before they are used in treatment.

The policy statement and hearing in the House Energy and Commerce Committee come a month after FDA released the details about its upcoming guidance for lab-developed tests and its guidance for companion diagnostics, both of which emphasize a "risk-based" approach to regulating LDTs and CDx tests.

Other speakers in today's House hearing include Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health; Andrew Fish, executive director of AdvaMed Diagnostics; and Alan Mertz, president of the American Clinical Laboratory Association.

AACR views a test as "high-risk" if its results are used to directly determine the course of treatment, or whether or not a treatment is given. Although such tests currently do not require FDA approval, AACR said in its policy statement, they are "widely considered as equivalent to FDA-approved diagnostic tests, and physicians, patients, and payors are often unaware of the regulatory review status of the specific test (FDA-approved test or LDT) being used."

"Having a single, strict, regulatory approval standard would reassure the public that the tests used in high-risk health care decision making, whether developed by a laboratory or other manufacturer, are safe, accurate, and effective," AACR said.

Currently, FDA plans to release a final draft guidance detailing the criteria for classifying LDTs as Class I, II, and III 18 months after it finalizes the LDT guidance.

"Having a single approval standard for all tests regardless of origin would also create a more predictable regulatory and investment climate for both the diagnostics and the pharmaceutical industries," Laura van't Veer, director of applied genomics at the University of California San Francisco's Helen Diller Family Comprehensive Cancer Center and co-author of the policy statement, said in a statement.

AACR published its LDT policy statement today online in the journal Clinical Cancer Research.