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Take the next step with MyChoice® CDx

Get started with MyChoice CDx by downloading the provider guide.

Take the next step with MyChoice® CDx

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
Myriad HRD Companion Diagnostic Test

Informing both early-line and late-line treatment decisions for patients with ovarian cancer

MyChoice® CDx gives you comprehensive clarity when making early and late-line ovarian cancer treatment decisions.

MyChoice® CDx
Myriad HRD Companion Diagnostic Test

Informing both early-line and late-line treatment decisions for patients with ovarian cancer

MyChoice® CDx gives you comprehensive clarity when making early and late-line ovarian cancer treatment decisions.

Knowing HRD status is essential in determining ovarian cancer treatment options

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.

There are limitations to determining HRD status when evaluating each cause individually

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 determines HRD status in multiple ways for comprehensive results

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

  • Detection and classification of sequence variants and large rearrangements
  • Identification of somatic and germline variants present in the tumor

Genomic instability status

LOH + TAI + LST

  • Comprehensive assessment of loss of heterozygosity (LOH), telomeric allelic imbalance (TAI) and large-scale state transitions (LST) across the entire genome

HRD Companion Diagnostic Test

The MyChoice CDx approach delivers the most accurate information for timely treatment decisions

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.

  • 27,000 SNPs capture a more defined look into the genome vs %LOH which uses 3,500 SNPs only looking at a percentage of the genome.
  • Platform technology that analyzes BRCA1/2, to include sequence variance and large rearrangements, capturing 5% more than other platforms who do not have this technology.5,10

Not all HRD tests are alike

MyChoice CDx is named in guidelines

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.

MyChoice CDx is recommended by ASCO

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.

Myriad
MyChoice® CDx
Caris
Molecular
Intelligence
Foundation
Medicine
FoundationOne CDx
Tempus
Tempus xT
Landmark published clinical trials Quadra, Paola, Prima,
SOLO
None SOLO, Ariel None
Guidelines ASCO (by name), NCCN None ASCO (For BRCA) None
FDA-approval Yes* No Yes No
HRD markers tBRAC, LOH, TAI, LST tBRAC, %LOH tBRAC, %LOH tBRAC
Comprehensive BRCA1/2 large
rearrangements performed?
Yes No No No

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

Clear, comprehensive results

To guide your ovarian cancer treatment decisions

Key report elements

  • Genomic instability score (GIS) status
  • Tumor Mutation BRCA1/BRCA2 Status (tBRCA1/2 Status)
  • Interpretation of any somatic 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

One simple order. Comprehensive results.

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.

What to expect with every MyChoice CDx test

Accurate

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.

Actionable

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.

Affordable

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.

MyChoice 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 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. 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.

References:
  1. Moore et. al, Lancet Oncol 2019
  2. Bonadio et al. Clinics 2018
  3. Watkins et al. Breast Ca Res 2014
  4. Panagiotis et al. Cancer Discov 2015
  5. https://info.foundationmedicine.com/hubfs/FMI%20Labels/FoundationOne_CDx_Label_Technical_Info.pdf
  6. Timms, et al. JClinOnc 2020 38:15_suppl, 1586-1586.
  7. Baldwin et al. Cancer Research 2000
  8. Norquist et al. JAMA Oncol. 2016
  9. The Cancer Genome Atlas. Nature 2011
  10. Timms, et al. JClinOnc 2020 38:15_suppl, 1586-1586.
  11. Moore, K. et al. (2018). Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. Published. https://doi.org/10.1056/NEJMoa1810858
  12. Ray-Coquard, I. et al. (2019). Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med. Published. https://doi.org/10.1056/NEJMoa1911361
  13. Gonzalez-Martin, A. et al. (2019). Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. Published. https://doi.org/10.1056/NEJMoa1910962
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