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Take the next step with MyChoice CDx

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MyChoice® CDx
Myriad HRD Companion Diagnostic Test

Breakthrough HRD testing for optimizing ovarian cancer treatment

MyChoice CDx is the only FDA-approved homologous recombination deficiency (HRD) test specifically mentioned in ASCO guidelines for selecting patients with ovarian cancer who may benefit from PARP inhibitors.1 By determining comprehensive HRD status, MyChoice CDx helps expand access to targeted therapy in both early and late-line settings.2

Comprehensive HRD testing informs ovarian cancer treatment options

Knowing homologous recombination deficiency (HRD) status is essential in determining ovarian cancer treatment options. Nearly 50% of ovarian cancer patients are HRD+.4-6 Determining HRD status for ovarian cancer patients can help provide information on the magnitude of benefit for PARP inhibitor therapy and bring clarity in ovarian cancer treatment decisions.3

~50% patients with ovarian cancer are HRD+ with ~25% of HRD+ patients having a BRCA1/2 mutation and ~25% are due to HRD+ other measures of genomic instability graphic

Graphic showing Myriad Oncology’s MyChoice CDx HRD test of proprietary technology of a comprehensive assessment of BRCA1/2 genes and tumor genomic instability score (GIS) to evaluate loss of heterozygosity (LOH), telomeric allelic imbalance (TAI) and large-scale state transitions (LST)

Overcoming the limitations of less sensitive tests in HRD detection

There is a critical need for integrated germline and tumor genomic testing in oncology, as up to 10% of germline mutations are missed through tumor testing alone.2

Determining HRD status through gene sequencing alone can miss critical causes, such as epigenetic events like BRCA1 promoter methylation and other measures of genomic instability.3,4 These limitations highlight the need for a more comprehensive approach to HRD assessment.

MyChoice CDx determines HRD status in multiple ways for comprehensive results

MyChoice CDx provides critical information to identify HRD+ patients who may benefit from PARP inhibitors, enabling more precise treatment decisions. This thorough methodology ensures no HRD cause is overlooked.

  • Determines HRD status by conducting a comprehensive assessment of BRCA1/2 genes and tumor genomic instability score (GIS) that includes loss of heterozygosity (LOH), telomeric allelic imbalance (TAI) and large-scale state transitions (LST)
  • Captures a more defined look into the genome vs %LOH alone, which looks at a smaller percentage of the genome2
  • Uses a platform technology that analyzes BRCA1/2 to include sequence variants and large rearrangements, capturing 5% more patients than other platforms that do not have this technology2

BRCA1 & BRCA2 status

  • Detection and classification of sequence variants and large rearrangements
  • Identification of germline and tumor pathogenic variants

Genomic instability score

  • Comprehensive assessment of LOH + TAI + LST across the entire genome
Chart showing HRD+ patients identified by using a Myriad Oncology MyChoice CDx test of high genomic instability score and high percentage loss of heterozygosity

MyChoice CDx helps expand access to PARP inhibitors2

MyChoice CDx can identify 34% more patients with HRD than other tumor tests that use %LOH alone2

MyChoice CDx: Trusted, proven, recommended

Recognized by the American Society of Clinical Oncology (ASCO), MyChoice CDx is the only commercial HRD test endorsed for selecting patients with advanced ovarian cancer who may benefit from PARP inhibitor therapies.1

Myriad Oncology MyChoice CDx female patient looking for information

How MyChoice CDx outperforms other HRD tests

Myriad
MyChoice® CDx
Caris
Molecular
Intelligence
Foundation
Medicine
FoundationOne CDx
Tempus
Tempus xT
Landmark published clinical trials PAOLA-17,8, PRIMA9,10, QUADRA11, SOLO112 None ARIEL2, SOLO1 None
Guidelines ASCO (by name) None ASCO (For BRCA1/2) None
FDA-approval Yes* No Yes No
HRD markers tBRCA, LOH, TAI, LST tBRCA, %LOH, LST tBRCA, %LOH tBRCA, %LOH
Comprehensive BRCA1/2 large
rearrangements performed?
Yes No No No

*MyChoice CDx received FDA-approved October 2019 with broad insurance coverage

Streamlined germline and tumor genomic results to guide your ovarian cancer treatment decisions

A cohesive report with a simple summary of key findings to help prioritize critical insights while keeping comprehensive data readily available.

Key report elements

  • Genomic instability score (GIS) status
  • Tumor BRCA1/BRCA2 status
  • Interpretation of any tumor BRCA1  and BRCA2  variants identified
  • Overall test interpretation most relevant to patient management (if multiple variants detected)

How to test with MyChoice CDx

MyChoice CDx delivers affordable results in 14 days or less*

Provider completes the test request form (on the portal or paper TRF)

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

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*

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)^

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)

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

Image showing Myriad Oncology’s portfolio of germline and tumor genomic test kits

One simple order. Comprehensive results.

With Myriad Oncology, you can receive comprehensive results for germline testing, tumor genomic profiling, and HRD testing in one single ordering experience, getting clear, fast answers for your patients.

Do more for more ovarian cancer patients with a comprehensive risk and recurrence assessment

For a complete approach to ovarian cancer risk management and treatment planning, MyChoice CDx should be combined with MyRisk and Precise Tumor to deliver powerful results informing patient care across the entire journey-from assessing hereditary cancer syndromes to guiding treatment decisions.

MyRisk Hereditary Cancer Test

Integrate germline and tumor genomic profiling with HRD testing to identify more patients most likely to benefit from PARP inhibitors. Precise Tumor and MyChoice deliver a powerful combination of actionable tumor genomic information and homologous recombination status, optimizing treatment strategies for ovarian cancers.

Precise Tumor® Molecular Profile Test

Combine HRD testing with tumor genomic profiling for a comprehensive view of all the available FDA-approved targeted therapies and immuno-oncology treatments options, as well as clinical trials most likely to benefit your patients with advanced ovarian cancer.

Myriad Oncology’s portfolio of products delivers:

  • Integrated genetic and tumor genomic insights to personalize care for each ovarian cancer patient
  • Confident risk and recurrence assessments to inform both preventive and therapeutic decisions
  • Streamlined reporting to prioritize actionable insights at every step of the cancer journey

What to expect with every MyChoice CDx test

Actionable

Every MyChoice CDx test delivers clear, actionable results, providing the critical information needed to guide ovarian cancer treatment decisions with confidence.

Accurate

MyChoice CDx determines HRD status through a combined evaluation of BRCA1/2 variants and genomic instability score (GIS) to ensure no HRD cause is overlooked.

Affordable

Transparent pricing for genetic results with financial assistance and other affordability options.

MyChoice CDx resources

MyChoice® CDx Myriad HRD Companion Diagnostic Test

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 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.

Table 1: Companion diagnostic indications

Tumor Type Biomarker Therapy
Ovarian Cancer
    Myriad HRD, defined as:

  • deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes and/or
  • positive Genomic Instability Score
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 in accordance with the most recently approved therapeutic product labeling. The MyChoice® CDx assay is for professional use only and is performed exclusively at Myriad Genetic Laboratories, Inc. site located in Salt Lake City, UT.

LYNPARZA is a registered trademark of the AstraZeneca group of companies.

References:
  1. Tew WP, Lacchetti C, Birrer MJ, et al. PARP inhibitors in the management of ovarian cancer: ASCO guideline. J Clin Oncol. 2020;38(30):3468-3493.
  2. Timms KM, Abkevich V, Hughes E, et al. Comparison of genomic instability test scores used for predicting PARP activity in ovarian cancer. J Clin Oncol. 2020;38(15_suppl):1586.
  3. Moore KN, Secord AA, Geller MA, et al. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial [published correction appears in Lancet Oncol. 2019 May;20(5):e242.
  4. da Cunha Colombo Bonadio RR, Fogace RN, Miranda VC, Diz MDPE. Homologous recombination deficiency in ovarian cancer: a review of its epidemiology and management. Clinics (Sao Paulo). 2018;73(suppl 1):e450s.
  5. Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D’Andrea AD. Homologous Recombination Deficiency: Exploiting the Fundamental Vulnerability of Ovarian Cancer. Cancer Discov. 2015;5(11):1137-1154.
  6. Watkins JA, Irshad S, Grigoriadis A, Tutt AN. Genomic scars as biomarkers of homologous recombination deficiency and drug response in breast and ovarian cancers. Breast Cancer Res. 2014;16(3):211.
  7. Ray-Coquard, Isabelle, et al. “Olaparib plus Bevacizumab First-Line Maintenance in Ovarian Cancer: Final Overall Survival Results from the Paola-1/ENGOT-OV25 Trial.” Annals of Oncology. 2023;34(8): 681-692.
  8. Ray-Coquard, Isabelle, et al. “Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer.” New England Journal of Medicine. 2019;381(25):2416-2428.
  9. González-Martín, Antonio, et al. “Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.” New England Journal of Medicine. 2019;381(25):2391-2402.
  10. González-Martín, Antonio, et al. “Progression-Free Survival and Safety at 3.5 Years of Follow-up: Results from the Randomised Phase 3 Prima/Engot-OV26/GOG-3012 Trial of Niraparib Maintenance Treatment in Patients with Newly Diagnosed Ovarian Cancer.” European Journal of Cancer. 2023;189:112908.
  11. Moore, Kathleen N, et al. “Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial.” The Lancet Oncology. 2019;20(5):636-648.
  12. Moore, Kathleen N, et al. “Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.” New England Journal of Medicine. 2018;379(26):2495-2505.

Myriad Genetics, MyRisk, Precise Tumor, MyChoice, Prolaris, BRACAnalysis CDx, RiskScore, and their respective logos, are registered trademarks of Myriad Genetics, Inc. and its subsidiaries in the United States and other jurisdictions. EndoPredict and the EndoPredict logo are either trademarks or registered trademarks of Eurobio Scientific.