Source: TrialTrove; L.E.K. research and analysis Rising BM use in trials has predictably had an impact on product launches, with the U.S. Food FDA-approved therapeutics with CDx, including novel oncological therapies (1997-2024) *Count of unique companion diagnostic-therapy combination approvals **Indication refers to broad cancer type and sample type (e.g., breast cancer or non-small cell lung cancer) rather than particular label indication, which may include factors such as age,line of therapy, other mutations or other patient/cancer characteristics **Includes the following types of mutations or mutations in the following genes/gene classes: BCR-ABL, C-kit, dMMR, ESR1, EZH2, FGFR2, Note: FDA=Food & Drug Administration Source: FDA list of approved companion diagnostic devices (accessed February 2025); L.E.K. research and analysis