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FDA Pilot Program for Certain In Vitro Diagnostic Tests

The U.S. Food and Drug Administration (FDA) has announced a pilot program designed to improve oncology patient care by establishing minimum performance standards for in vitro diagnostic tests (IVDTs) used with a limited number of oncology drug products. An IVDT is a device that provides critical information for the safe and effective use of a therapeutic product. The FDA typically requires a companion diagnostic to receive marketing authorization concurrently with the approval of the corresponding therapeutic product. However, in cases where no satisfactory alternative treatment exists for a serious or life-threatening condition, the FDA may approve a therapeutic product even without a companion IVDT. Currently, laboratory developed tests (LDTs) are being used in such cases, and the FDA exercises enforcement discretion regarding these tests.



The pilot program aims to improve drug selection and patient care by establishing minimum performance characteristics for certain LDTs used in identifying patients for treatment with specific oncology drugs.

As a part of the pilot program, the FDA plans to recommend minimum analytical performance characteristics for certain tests used in oncology drug products. These recommendations are intended to establish a benchmark for test developers to design accurate and reliable tests for identifying patients for oncology treatment.

These performance characteristics would be based on the clinical validity established for the clinical trial assays (CTAs) used in the pivotal clinical trials supporting the approval of the drug products. The minimum performance characteristics would be recommended for other tests of the same type, and when these tests demonstrate the recommended performance through properly conducted validation studies, the FDA believes their clinical validity can be extrapolated.

Participation in the pilot program is open to drug product sponsors who meet specific criteria. These include the need for an IVDT to identify the intended patient population, the absence of satisfactory alternative treatments, and the substantial benefits outweighing the risks of approval without an FDA-authorized companion diagnostic.

Drug product sponsors interested in the pilot program should submit a Statement of Interest along with their IND, NDA, or BLA applications. The FDA will review the factors outlined in the document to determine acceptance into the program and provide written feedback. The FDA has provided templates on its website to facilitate the submission of performance characteristic and validation information for the CTAs used in pivotal clinical trials. The minimum recommended performance characteristics for IVDTs associated with approved drug products will also be publicly available on the FDA's website.

The FDA intends to update the guidance based on the initial phase of the pilot program and plans to expand the program to evaluate additional sponsors for acceptance. This pilot program aims to enhance oncology patient care by establishing standardized performance criteria for diagnostic tests used in conjunction with oncology drug products.

Download the full FDA guidance document here, and read the Federal Register notice here.

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