MyChoice® CDx
Myriad HRD Companion Diagnostic Test

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

Order a test kit

MyChoice® CDx
Myriad HRD Companion Diagnostic Test

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

Order a test kit

Provider guide

Intended use

MyChoice® CDx Product Overview

MyChoice CDx is the most comprehensive tumor test that determines HRD status in women with ovarian cancer. Homologous recombination deficiency (HRD) is present in approximately 48% of ovarian cancer tumors1, most often resulting from a mutation found only within the tumor. Determining HRD status for ovarian cancer patients can help provide information on the magnitude of benefit for PARP inhibitor therapy.

Some causes of HRD are well established while others remain unknown2,3,4

Causes of HRD

There are many ways HRD status can be measured

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

Causes of HRD

There are many ways HRD status can be measured

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

The MyChoice CDx Approach

genome

Uses 54,000 SNPs, capturing a more defined look into the genome vs %LOH which uses 3,500 SNPs only looking at a percentage of the genome.

genome

Uses a 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

Studies show that by using these methods, 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.

Not all HRD tests are alike

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 CARIS Molecular Intelligence FOUNDATION MEDICINE FoundationOne CDx TEMPUS Tempus xT
Published Clinical Trials QUADRA1
PRIMA13
PAOLA12
SOLO11
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

*FDA-approved (OCT 2019) with broad insurance coverage and uncapped financial assistance program limit.

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. Br Ca Res 2014
  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

MyChoice® CDx can inform early-line treatment decisions with LYNPARZA® (olaparib) and late-line treatment decisions with ZEJULA® (niraparib)

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

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)
Zejula® (niraparib)

* 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.

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

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