With pilot program, FDA seeks to reduce risks of LDTs that identify cancer biomarkers

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The U.S. Food and Drug Administration (FDA) on Tuesday released a voluntary pilot program for specific oncology drugs used with in vitro diagnostic tests (IVDs) that enable the selection of cancer treatments.

The pilot program aims to help reduce risks associated with using laboratory developed tests (LDTs) to identify cancer biomarkers, the agency said.

In oncology, the FDA approves specific tests that identify patients, such as those with a particular genetic mutation, who may or may not benefit from a cancer treatment. It also approves treatments that require use of a companion diagnostic test even when the test has not yet received marketing authorization. In these cases, LDTs developed and used in a specific laboratory are used for patient treatment decisions.

The FDA generally has not enforced requirements for most LDTs, and unlike those that are approved, authorized, or cleared by the agency, the tests are not generally reviewed by the FDA for safety or effectiveness.

Nonetheless, the agency has become increasingly concerned, it said, that some tests made by laboratories that it has not authorized may not provide accurate and reliable test results or perform as well as FDA-authorized tests.

The pilot program is one step that may be helpful in reducing the risk of using LDTs for oncology drug treatment decisions, the FDA said, while it continues to work on a broader approach for LDTs, including moving forward with rulemaking.

"We believe this guidance and the launch of the pilot program are important steps toward addressing safety risks posed by the use of poorly performing laboratory developed tests," Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments."

Through the pilot program, the FDA will request from drug manufacturers performance information for the tests used to enroll patients into the clinical trials that support drug approval. Based on an assessment of that information, the FDA will post to the FDA website the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug.

Laboratories may use this information to guide their development of LDTs to identify specific biomarkers used for selecting cancer treatment, the FDA said, adding that this transparency aims to help facilitate better and more consistent performance of these tests, resulting in better drug selection and improved care for patients with cancer.

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