Cancer-Related Germline Gene Mutation Detection System
Basic Information
- Device Name
- Cancer-Related Germline Gene Mutation Detection System
- Trade Name
- myChoice HRD CDx
- PMA Number
- P190014
- 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
- October 23, 2019
- Date Received
- May 3, 2019
- Expedited Review
- N
- Docket Number
- 19M-4978
Advisory Committee Statement
Approval of Myriad myChoice® CDx. Myriad myChoice® CDx is a next generation sequencing-based in vitro diagnostic test that assesses the qualitative detection and classification of single nucleotide variants, insertions and deletions, and large rearrangement variants in protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes and the determination of Genomic Instability Score (GIS) which is an algorithmic measurement of Loss of Heterozygosity (LOH), Telomeric Allelic Imbalance (TAI), and Large-scale State Transitions (LST) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. The results of the test are used as an aid in identifying ovarian cancer patients with positive homologous recombination deficiency (HRD) status for treatment with the targeted therapy listed in Table 1 in accordance with the approved therapeutic product labeling.Table1---Tumor Type: Ovarian Cancer, Biomarker: Myriad HRD (defined as deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes and/or positive Genomic Instability Score), Therapy: Zejula® (niraparib)
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 |