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FDA Launches Pilot Program Using Cancer Biomarkers to Mitigate Risk

June 21, 2023


On June 20, 2023, FDA announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in-vitro diagnostic tests. The goal of this program is to help clinicians select appropriate cancer treatments for patients.

Under current guidelines, an in-vitro companion diagnostic test is one that provides information needed for the safe and effective use of a corresponding treatment. In certain limited circumstances, FDA may decide to approve a life-saving treatment that requires an in-vitro companion diagnostic even if a corresponding in-vitro companion diagnostic has not yet received marketing authorization. In these situations, laboratory developed tests (LDTs) are being used for patient treatment decisions, but these are not generally reviewed by the agency for safety or effectiveness.

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