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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicemyChoice HRD CDx
Generic NameCancer-related germline gene mutation detection system
ApplicantMyriad Genetic Laboratories, Inc
320 Wankara Way
Salt Lake City, UT 84108
PMA NumberP190014
Date Received05/03/2019
Decision Date10/23/2019
Product Code PJG 
Docket Number 19M-4978
Notice Date 10/28/2019
Advisory Committee Pathology
Clinical TrialsNCT02354586
Expedited Review Granted? No
Combination ProductNo
Approval Order 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)
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
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