The most comprehensive tumor test to determine HRD status in patients with ovarian cancer
The first and only FDA-approved tumor test that determines HRD status using BRCA status and Genomic Instability Status
FDA-approved for both first-line maintenance therapy and late line monotherapy for Zejula® (niraparib) for patients with ovarian cancer.
Results in 14 days or less
Used in multiple clinical trials
QUADRA, PRIMA, and PAOLA
FDA approved with broad insurance coverage
What is myChoice® CDx?
Hereditary Cancer and Tumor Testing - Why Use Both?
Using a hereditary cancer test as a part of the ovarian cancer workup can provide critical information about hereditary risk to make the best treatment decisions for your patient. You can receive both hereditary and tumor treatment answers in one order by using Myriad.
To learn how to order both hereditary cancer and tumor test in one order through an electronic request form visit MyriadPro.com, and visit our Virtual Ordering page to learn how to order hereditary cancer and tumor tests in one order with direct to patient options.
myChoice® CDx Intended Use
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, 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.
Table 1: Companion diagnostic indications
|Ovarian Cancer||Lynparza® (olaparib)|
* Refer to the drug label for HRD definition for olaparib monotherapy or combination therapy
Detection of deleterious or suspected deleterious BRCA1 and BRCA2 mutations and/or positive Genomic Instability Score in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula® (niraparib) maintenance therapy. 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.