Genomic Testing

FOUNDATIONFOCUS™ CDx BRCA

The first FDA-approved companion diagnostic test for Rubraca® (rucaparib), a PARP inhibitor therapy for the treatment of advanced ovarian cancer.
  • Cancer Type
    Solid Tumor (Ovarian)
  • Sample Type
    FFPE
  • Results Expected
    <2 weeks*

What is FoundationFocus CDx BRCA?

FoundationFocus CDx BRCA is the first FDA-approved companion diagnostic assay for Rubraca® (rucaparib), a PARP inhibitor therapy for the treatment of advanced ovarian cancer.

Conventional tests look only for germline alterations in blood or saliva. FoundationFocus CDx BRCA analyzes ovarian cancer tumor tissue to detect both germline (inherited) and somatic (acquired) BRCA1/2 mutation types associated with response to PARP inhibitor therapy.1,2

Indications, Contraindications, and Limitations

Overview

FoundationFocus CDx BRCA

  • 1 in 4

    women with ovarian cancer are BRCA+ (positive)

  • 50%

    Germline+ (positive)

  • 50%

    Somatic+ (positive)

  1. First FDA-approved next-generation sequencing (NGS) companion diagnostic for Rubraca®
  2. Uncovers more BRCA mutations with a single tissue test
  3. Can help identify more women who may benefit from Rubraca®, a PARP inhibitor therapy, as compared to germline testing alone 2-5

Publications

FoundationFocus CDx BRCA was used in Clovis Oncology, Inc.’s pivotal trial, ARIEL2. The assay was used to identify patients and to assess the ability of the assay to predict their response to Rubraca ®.

Published Clinical Study

Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma

The ARIEL2 study assessed the ability of tumour genomic LOH, quantified with a next-generation sequencing assay, to predict response to rucaparib, an oral PARP inhibitor.

View the Published Paper

Published Clinical Study

BRCA somatic mutations and epigenetic BRCA modifications in serous ovarian cancer

In this review, the role of somatic BRCA mutations and BRCA methylation in ovarian cancer is discussed alongside the challenges that need to be addressed if the full potential of these markers of HRD is to be utilised in clinical practice.

View the Published Paper

Interested in learning more about how a Comprehensive Genomic Profiling test might help your patient? Our publications can help:

View all reports & validation

Order FoundationFocus CDx BRCA

We provide physicians with several options for ordering FoundationFocus CDx BRCA for patients, including online, fax, and e-mail. Healthcare providers must first complete a test requisition form to start the process and can expect results typically less than 2 weeks from the time a specimen is received.

A doctor looking at the camera

Patients

FoundationFocus CDx BRCA is ordered by your healthcare provider. Our patient info kit has all the information you and your doctor need to discuss FoundationFocus CDx BRCA testing.

Download Patient Brochure

Providers

FoundationFocus CDx BRCA can be ordered online, by fax, or by phone. Please review and complete the provider resources before ordering.

Order Now

Questions? We’re here to help.

Call Foundation Medicine Client Services at (888) 988-3639 between 8:00 am ET and 8:00 pm ET, Monday through Friday. You can also send us an email and a representative will respond during regular business hours.

Contact Us

We have even more to offer.

Learn more about our other tests, FoundationACT®, FoundationOne®, FoundationOne®Heme, or explore insights and trials or partnerships.

* Typical turnaround time from receipt of specimen is less than two weeks.

Rubraca® is a registered trademark of Clovis Oncology.

  1. 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.
  2. 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.
  3. 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.
  4. Arts-de Jong M, et al. Germline BRCA1/2 mutation testing is indicated in every patient with epithelial ovarian cancer: A systematic review. Eur J Cancer. 2016;(61):137-145.
  5. The ratio of germline to somatic BRCA alterations varies based on population studied.