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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.
Cancer:
Ovarian Cancer
Gene:
BRCA1 (Breast cancer 1, early onset), BRCA2 (Breast cancer 2, early onset)
Drug:
Lynparza (olaparib), Zejula (niraparib)
Method:
Next-Generation Sequencing (NGS)
Approvals
Date
Cancer
Gene
Drug
By
10/23/19
FDA
05/08/20
FDA
Confirmatory trial(s)