Presentation (CTI)

OBJECTIVES: Companion diagnostics (CDx) guide safe and effective use of targeted therapies by identifying patients with specific biomarkers. We characterized FDA CDx approvals from 1998 to 2024, including new tests versus expanded use approvals, trends in technology and specimen type, timing relative to drug approvals, and approvals by manufacturer.
METHODS: We conducted a retrospective cross-sectional analysis of the FDA database of approved or cleared companion diagnostic devices. All tests meeting FDA CDx criteria and approved from 1998 to 2024 were included (N=185). We summarized approvals per year (new vs supplemental), described platform and specimen type among new CDx, calculated the lag between drug approval and CDx approval (inaugural and second CDx for the same drug biomarker), and tabulated approvals by manufacturer.
RESULTS: We identified 185 CDx approvals, including 64 new tests (35%) and 121 supplemental expansions (65%). Annual approvals increased in the late 2010s and peaked at 20 in 2020. Multi gene next generation sequencing panels accounted for 41% of new CDx in 2020 to 2024 (0% in 1998 to 2014), and about 30% of new CDx in 2020 to 2024 were blood based (liquid biopsy) tests. Inaugural CDx were typically approved at the time of drug approval (median lag about 0 years), while second CDx for the same drug biomarker were approved later (median 2 to 4 years). Roche (including affiliates) accounted for 21 of 64 new tests (33%); seven other manufacturers had multiple CDx, and 14 manufacturers had one each.
CONCLUSIONS: FDA CDx approvals have expanded and increasingly use multiplex and blood-based approaches. The pattern of CDx at drug launch with additional options later supports policies that enable timely drug diagnostic co-approval and multiple high quality testing options for patients and providers.