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Introduction Description
Introduction

myChoice® HRD is the most comprehensive tumor test that determines HRD status in patients with ovarian cancer. This FDA-approved test helps provide information on the magnitude of benefit for PARP inhibitor therapy.

HRD status is determined using two individual methods: BRCA1 & BRCA2 status that encompasses sequence variants and large rearrangements and Genomic Instability Status encompassing Loss of Heterozygosity, Telomeric Allelic Imbalance and Large-Scale state transitions across the entire genome.

It is the only commercially available tumor test that has been designed to detect large rearrangements which account for 5% of all ovarian cancer mutations.

Description

Myriad myChoice® HRD 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, who are eligible, because of a positive test result for deleterious or suspected deleterious mutations in BRCA1 or BRCA2 genes, or may become eligible, because of a positive test result for deleterious or suspected deleterious mutations in BRCA1 or BRCA2 genes or a positive Genomic Instability Score, for treatment with the targeted therapy listed in Table 1 in accordance with the approved therapeutic product labeling.