FoundationOne CDx has received FDA approval as a companion diagnostic for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.
FoundationOne CDx was also approved under accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
FoundationOne CDx is sponsored by Foundation Medicine.
FoundationOne CDx is the first and only FDA-approved companion diagnostic to measure TMB and help identify patients who may be appropriate for treatment with Keytruda, regardless of solid tumor type.
FoundationOne CDx, Foundation Medicine’s comprehensive genomic profiling assay approved for all solid tumors, enables oncologists to identify TMB-H patients (≥ 10 mutations/megabase) with unresectable or metastatic solid tumors across all tumor types who could potentially benefit from Keytruda.
FoundationOne CDx is the first FDA-approved CGP test that is clinically and analytically validated for all solid tumors and incorporates multiple companion diagnostic claims. It is currently approved as the companion diagnostic test for more than 20 therapies across multiple cancer types.
