What is myChoice® HRD?
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.
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
myChoice® HRD Intended Use
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.
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)||Lynparza® (olaparib)
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.
myChoice® HRD FAQs
How do I get tested?
Speak to your doctor. Once your doctor orders a test for you from us, we will take care of the rest. The clinic will prepare the tissue sample and send it to the lab for testing. The lab cannot accept a test directly from you, as a doctor first needs to assess whether or not the test is right for you. Once the testing is completed, a report will be sent to your doctor who will then go through and explain your results to you, and suggest the next steps.
Can I use any other sample collection kit that is not provided by Myriad?
No! Our processes have been optimized and validated with the kits we provide.
Which completed forms must accompany my sample?
The clinic will help you complete and sign an Informed Consent Form. This form will be submitted with the sample. The consent form will be used to match your sample to the test request submitted by the doctor, and is needed to let the lab know that you have agreed to send your sample for the test. Samples received without these forms cannot be processed, as your consent is required to test your sample.
Who will receive the test results?
Myriad will provide your test report to the healthcare professional who ordered the test.
Why are the results of testing sent directly to the ordering healthcare professional rather than the patient or parent of a patient?
Results are sent to the ordering healthcare professional as they would need to discuss the results, result interpretation, treatment management, and any follow-up testing with you.