U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for AstraZeneca’s Truqap™ (capivasertib) in combination with Faslodex® (fulvestrant) to Identify Patients with HR-Positive, HER2-Negative Advanced Breast Cancer
“This companion diagnostic approval adds to the growing utility of Foundation Medicine’s high-quality diagnostic test portfolio in treating advanced breast cancer.”
- “This companion diagnostic approval adds to the growing utility of Foundation Medicine’s high-quality diagnostic test portfolio in treating advanced breast cancer.”
Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. - Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor.
- The test currently has over 35 companion diagnostic indications, five of which are in breast cancer.
- The company has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing.