Get started with MyChoice CDx by downloading the provider guide.
Whether you’ve heard about genetic testing before or want to learn more, we can help provide in-depth information on the test and your testing options.
MyChoice® CDx gives you comprehensive clarity when making early and late-line ovarian cancer treatment decisions.
Homologous recombination deficiency (HRD) is present in approximately 48% of ovarian cancer tumors1, most often resulting from a mutation found only within the tumor. Some causes of HRD are well established, while others remain unknown2,3,4.
Determining HRD status for ovarian cancer patients can help provide information on the magnitude of benefit for PARP inhibitor therapy and bring you clarity in ovarian cancer treatment decisions.
HRD resulting from epigenetic events such as BRCA1 promoter methylation will be missed with a gene sequencing approach.6,7
HR pathway gene mutations other than BRCA1 and BRCA2 are rare, and it is unclear if they are connected to HRD.8,9
There is a distinct genomic effect associated with HRD.3
Evaluating LOH, TAI and LST allows for the assessment of HRD regardless of the specific cause.3
MyChoice CDx examines ovarian cancer tumors using two methods (BRCA1/2 mutation and genomic instability) to determine a patient’s HRD status.
BRCA1 & BRCA2 status
Sequence variants + Large rearrangements
Genomic instability status
LOH + TAI + LST
Studies show that by using the methods below, MyChoice CDx can identify 34% more tumors with HRD than other testing methods that use %LOH alone5, ensuring you have the most accurate information to make informed treatment decisions.
MyChoice CDx is the only test that is named in guidelines and is the only test that is listed in all the clinical studies that originated PARPi therapy in ovarian cancer patients.
Myriad MyChoice CDx is the only commercial companion diagnostic included in the new recommendations from The American Society of Clinical Oncology (ASCO) on the use of PARP inhibitors for the treatment and management of certain patients with advanced ovarian cancer.
*MyChoice CDx received FDA-approved October 2019 with broad insurance coverage
Provider completes the test request form (on the portal or paper TRF)
Myriad Genetics receives the TRF and sends a tumor specimen collection kit to the pathology lab
Tumor sample** arrives at Myriad Genetics lab and MyChoice CDx testing is performed*
Results are sent to the ordering provider (on the portal or in the mail)^
Tumor block is returned to the pathology lab immediately after result reporting
(slides will not be returned)
*Upon receipt of tumor specimen
**MyChoice CDx is run on formalin-fixed paraffin-embedded (FFPE) ovarian tumor tissue
^Results may be sent to the pathologist on the portal or in the mail
With Precise™ Oncology Solutions, you can receive results for comprehensive germline testing, tumor profiling and companion diagnostic options, including MyChoice CDx, in one single ordering experience, getting clear, fast answers for your patients.
Myriad believes in providing the most accurate and highest quality tests for patients. From hereditary cancer to precision medicine, our tests are designed to give providers and patients the most accurate answer possible.
Every MyChoice CDx test provides actionable results with GIS, BRCA1 and BRCA2 variant interpretation, and combined results to inform ovarian cancer treatment decisions. Our results are easy to read and provide the necessary information needed to make important treatment decisions.
Myriad is committed to providing patients with access to accurate and affordable genetic results through extensive coverage with most insurance plans and financial assistance programs.
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 formalinfixed 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 most recently approved therapeutic product labeling.
* 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 in accordance with the most recently approved therapeutic product labeling. 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.
LYNPARZA is a registered trademark of the AstraZeneca group of companies.