Today, Foundation Medicine introduced FoundationFocus™ CDxBRCA, our first product to be approved by the U.S. Food and Drug Administration (FDA). This companion diagnostic is intended to aid in identifying women with ovarian cancer for whom treatment with Rubraca™ (rucaparib) tablets, a therapy developed by Clovis Oncology, Inc., is being considered. Rubraca is an FDA-approved monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy by an FDA-approved companion diagnostic for Rubraca. It belongs to a class of cancer drugs called poly-ADP-ribose polymerase (PARP) inhibitors.

This year alone, 22,000 women will potentially be diagnosed with ovarian cancer, the leading cause of female gynecologic cancer-related deaths.1,2 Of this population, one in four women has a BRCA gene mutation.3 The presence of BRCA mutations can help predict responses to PARP inhibitors, but current methods of conventional testing detect only those BRCA mutations that are inherited and does not account for mutations that are acquired, or about half the total.4

For women with advanced ovarian cancer, time and treatment options are limited, and there is a significant need for efficient ways of identifying those most likely to respond to effective therapy.

FoundationFocus CDxBRCA is an FDA-approved tissue-based, genomic assay that uniquely detects tumor BRCA1 and BRCA2 mutations (may include both germline (inherited) and somatic (acquired)) in ovarian cancer. FoundationFocus CDxBRCA may help identify more women who could benefit from Rubraca therapy as compared to conventional testing methods that only identify germline BRCA1/2 mutations. Germline BRCA1/2 testing accounts for approximately half of all BRACA1/2 mutations. 4,5

These approvals are the culmination of an innovative, multi-year collaboration and coordinated regulatory strategy with Clovis Oncology.

The FDA approval of FoundationFocus CDxBRCA is an important step towards realizing our goal of commercializing a universal companion diagnostic assay for multiple tumor types to advance precision medicine in cancer. If approved by the FDA and the Centers for Medicare and Medicaid Services (CMS), FoundationOne® would be a CGP assay that incorporates multiple companion diagnostics to support precision medicine in oncology, including an indication for use as a companion diagnostic across a diverse range of solid tumors, all in a single test.

We are proud to have the opportunity to make an impact on the lives of women with ovarian cancer, and we continue our commitment to redefining the future of precision medicine through advanced companion diagnostics.

Click here to earn more about FoundationFocus CDxBRCA, Foundation Medicine’s first FDA-approved companion diagnostic.

  1. American Cancer Society. 2016, February 4. Overview of ovarian cancer. Retrieved from
  2. Ovarian Research Fund Alliance. (n.d.) Statistics. Retrieved from
  3. Moschetta M, George A, Kaye SB, Banerjee S. BRCA somatic mutations and epigenetic BRCA modifications in serous ovarian cancer. Ann Oncol. 2016 Aug;27(8):1449-55.
  4. Hennessy BTJ, et al. Somatic mutations in BRCA1 and BRCA2 could expand the number of patients that benefit from poly (ADP ribose) polymerase inhibitors in ovarian cancer. JCO. 2010;28(22):3570-6.
  5. Pennington KP, et al. Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas. Clin Cancer Res. 2013;20(3):764-75.