PMA P160018

Device

FoundationFocus CDx BRCA HRD

Applicant

Foundation Medicine, Inc.

PMA number

P160018

Supplement

S001

Product code

PQP

Decision date

2018-04-06

Classification

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Generic name

Next generation sequencing oncology panel, somatic or germline variant detection system

Approval order statement

Approval for the FoundationFocus™ CDx BRCA LOH. The device is an assay that uses next-generation sequencing (NGS) for qualitative detection of BRCA1 and BRCA2 sequence alterations and genomic loss of heterozygosity (LOH) from formalin-fixed, paraffin-embedded (FFPE) ovarian tumor tissue. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious tumor BRCA variants (tBRCA-positive), who may be eligible for treatment with Rubraca (rucaparib). Positive homologous recombination deficiency (HRD) status (defined as tBRCA-positive or LOH high) in ovarian cancer patients is associated with improved progression-free survival (PFS) from Rubraca (rucaparib) maintenance therapy. See the RUBRACA product label for information about guiding therapy in specific clinical circumstances. This test is to be performed at Foundation Medicine, Inc., a single laboratory site, located at 150 Second Street, Cambridge, Massachusetts.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf16/P160018S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>