What is Myriad myChoice CDx?
myChoice CDx is the first and only FDA-approved tumor test that determines homologous recombination deficiency status by detecting BRCA1 and BRCA2 (sequencing and large rearrangement) variants and assessing genomic instability using three critical biomarkers: loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions.
On October 23, 2019, myChoice CDx became commercially available with a list price of $4,040. To order myChoice CDx, click here: bit.ly/myChoiceCDxTRF. For more information on myChoice CDx, click here: bit.ly/myChoiceCDxSpecs.
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.
Table 1: Companion diagnostic indications
|Ovarian Cancer||Myriad HRD (defined as deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes and/or positive Genomic Instability Score )||Zejula® (niraparib)|
This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, Inc., a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.
Learn more about Myriad’s myChoice® CDx