Cancer-Related Germline Gene Mutation Detection System
Basic Information
- Device Name
- Cancer-Related Germline Gene Mutation Detection System
- Trade Name
- BRACAnalysis CDx
- PMA Number
- P140020
- Supplement Number
- S012
- Device Class
- FDA Class 3
- Product Code
- PJG
- Generic Name
- Cancer-related germline gene mutation detection system
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 12, 2018
- Date Received
- August 31, 2017
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for the BRACAnalysis CDx®. The device is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.Results of the test are used as an aid in identifying breast and ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment with Lynparza® (olaparib). Detection of deleterious or suspected deleterious germline BRCA variants by the BRACAnalysis CDx® test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula® (niraparib) maintenance therapy. This assay is for professional use only and is to be performed only at 320 Wakara Way, Salt Lake City, Utah.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PJG | Cancer-Related Germline Gene Mutation Detection System | FDA class 3 | Unknown |