myChoice HRD CDx
FDA premarket approval P190014 · decided 2019-10-23
Approval details
- PMA number
- P190014
- Trade name
- myChoice HRD CDx
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories, Inc.
- Date received
- 2019-05-03
- Decision date
- 2019-10-23
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake City, UT
- 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 Imbalan
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