Earlier today (20 June, 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for Drug Evaluation and Research and Oncology Center of Excellence
released final guidance on a voluntary program "Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program".
This pilot program provides transparency regarding minimum performance requirements for in vitro diagnostic tests used with oncology drug products enrolled in the pilot program in order to improve oncology patient care.
The in vitro companion diagnostic test provides information that is essential for safe and effective use of a corresponding therapeutic product.
The FDA expects to recommend minimum performance characteristics for in vitro diagnostic tests that will be used to identify patients for treatment with oncology drug products enrolled in this pilot program if the FDA approves a drug product enrolled in this pilot program.
A minimum set of performance characteristics will serve as a benchmark for test developers when designing accurate and reliable test designs.
According to FDA, the labeling of approved drugs under this pilot program will specify that the drug is indicated for patients who exhibit a specified biomarker from in vitro diagnostic tests that meet FDA performance specifications.
To know in detail about the pilot program, participation & procedures, click this LINK.
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