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FoundationFocus CDxBRCA LOH - P160018/S001

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: FoundationFocus™ CDx BRCA LOH
PMA Applicant: Foundation Medicine, Inc.
Address: 150 2nd Street 1st Floor, Cambridge, MA 02141
Approval Date: April 6, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160018S001a.pdf

What is it? FoundationFocus™ CDx BRCA LOH was originally approved as a companion diagnostic designed to detect the presence of mutations in the BRCA1 and BRCA2 genes. The laboratory test can also be used to detect the percentage of genomic loss of heterozygosity (LOH) in tumor tissue samples from patients with ovarian cancer. BRCA1 and BRCA2 stand for Breast Cancer, early onset genes 1 and 2, which are also associated with ovarian cancer. LOH is a genetic event that occurs in many cancer types, and results in the loss of one allele (or copy) of a genetic locus. Patients with BRCA mutations or a high percentage of LOH are classified as positive for homologous recombination deficiency (HRD), which means cells are less able to repair harmful breaks on both strands of DNA. If BRCA mutations are detected or patients have positive HRD status, the patients may be considered for treatment with Rubraca (rucaparib).

Rubraca (rucaparib) is a treatment for patients who have been previously treated for ovarian cancer who have BRCA mutations or positive HRD status, as detected by the FoundationFocus™ CDx BRCA LOH. Rubraca (rucaparib) blocks proteins involved in important cell functions, such as repair of damaged DNA.

How does it work?

  • The doctor orders the test. A tissue sample from the tumor of a patient with ovarian cancer is taken by the doctor, and the sample is sent to Foundation Medicine, Inc. in Cambridge, MA.
  • At Foundation Medicine, Inc., the patient's DNA is isolated from the tumor tissue sample, and then mixed with reagents that specifically detect and analyze the DNA sequences. The patient's sequenced DNA is then analyzed to evaluate the presence or absence of BRCA mutations, the percentage of LOH, and the HRD status.
  • A trained medical professional reviews the results, and then sends a report to the ordering doctor.
  • The presence of BRCA mutations or positive HRD status will be used to help inform treatment decisions with Rubraca™ (rucaparib).

When is it used? FoundationFocus™ CDx BRCA LOH is used to determine if patients previously treated for ovarian cancer may benefit from treatment with Rubraca™ (rucaparib).

What will it accomplish? FoundationFocus™ CDx BRCA LOH helps to inform treatment decisions with Rubraca™ (rucaparib).

When should it not be used? There are no known contraindications.

Additional information (including warnings, precautions, and adverse events):