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MyChoice CDx Plus HRD Companion Diagnostic Test –

the gold-standard HRD test for ovarian cancer

Why test for homologous recombination deficiency?

Homologous recombination deficiency (HRD) is present in around 50% of women with ovarian cancer.1

PARP inhibitors like olaparib or niraparib offer these women better outcomes after initial chemotherapy and are proven to provide the longest progression-free survival interval in a first-line maintenance setting of HRD positive ovarian cancer patients.2

How MyChoice CDx Plus tests HRD differently

MyChoice CDx Plus is a next generation sequencing-based HRD test which accurately identifies HRD status for every woman with ovarian cancer – by targeting both upstream causes and downstream effects.

MyChoice measures genomic instability instead of all causes of homologous recombination deficiency

MyChoice CDx Plus uses a novel and proprietary measurement called genomic instability score (GIS) which targets three key biomarkers – telomeric allelic imbalance (TAI), loss-of-heterozygosity (LOH), and large-scale transitions (LST).

GIS gives a unique insight into the phenotype of genomic instability associated with HRD, allowing MyChoice CDx Plus to measure downstream effects of HRD5,6,7

What about BRCA mutation testing?

MyChoice CDx Plus combines BRCA tumor mutation testing and GIS to go further in identifying:

  • 2 times as many HRD positive patients as tumor BRCA mutation testing8,9
  • 3.5 times as many HRD positive patients as germline BRCA mutation testing
  • MyChoice CDx Plus also incorporates large rearrangement testing of tumor BRCA to detect an additional 5% of mutations, adding a more comprehensive analysis of BRCA1/2 than traditional somatic gene assays.

HRD testing has life-changing consequences for every woman with ovarian cancer, and MyChoice CDx Plus is here to guide treatment decisions for each one

MyChoice CDx Plus is the gold-standard HRD test for ovarian cancer

Reliable – MyChoice CDx Plus identifies patients who benefit (HR=0.33) and do not benefit (HR=1.00) from first-line olaparib combination therapy.2

Clinically validated – MyChoice CDx Plus is the only HRD test with Level of Evidence
1A to guide first-line PARP inhibitor maintenance.10

Trusted worldwide – The FDA, PMDA and international guidelines trust MyChoice CDx Plus. ESMO recognizes MyChoice CDx Plus is the only scar based HRD test validated in the first-line maintenance setting.10 ASCO recommends it specifically for this setting.11

Fast turnaround time – Clinicians will get a MyChoice CDx Plus result back within two weeks after the pathology lab has received the sample.

How to order a MyChoice CDx Plus test

To begin using MyChoice CDx Plus to help guide treatment decisions, please fill in the Test Request Form below in your preferred language. Technical specifications are available and also contact information for clinicians, if you would prefer to speak to someone.

If you are a patient, you can speak to your doctor for for more information on HRD testing.

Intended Use

Myriad Genetics MyChoice® CDx Plus is a next generation sequencing based in vitro diagnostic device that provides sequencing and large rearrangement analyses on a panel of genes and/or detects genomic instability using DNA extracted from tumor specimens. Homologous Recombination Deficiency (HRD) is determined by assessing the results of a subset of these genes and/or the Genomic Instability Score (GIS) Status. The test may be used as a companion diagnostic to identify patients who are or may become eligible for treatment with specific therapies in accordance with the approved therapeutic product labeling. Results are to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with malignant solid tumors.

References

  1. 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, vol 20, no. 5, 2019, pp. 636-648. Elsevier BV.
  2. Ray-Coquard, Isabelle et al. “Olaparib Plus Bevacizumab As First-Line Maintenance In Ovarian Cancer”. New England Journal Of Medicine, vol 381, no. 25, 2019, pp. 2416-2428. Massachusetts Medical Society.
  3. Watkins, Johnathan A et al. “Genomic Scars As Biomarkers Of Homologous Recombination Deficiency And Drug Response In Breast And Ovarian Cancers”. Breast Cancer Research, vol 16, no. 3, 2014. Springer Science And Business Media LLC.
  4. Norquist, Barbara M. et al. “Inherited Mutations In Women With Ovarian Carcinoma”. JAMA Oncology, vol 2, no. 4, 2016, p. 482. American Medical Association (AMA).
  5. Abkevich, Victor et al. “Patterns Of Genomic Loss Of Heterozygosity Predict Homologous Recombination Repair Defects In Epithelial Ovarian Cancer”. British Journal Of Cancer, vol 107, no. 10, 2012, pp. 1776-1782. Springer Science And Business Media LLC.
  6. Birkbak, Nicolai J. et al. “Telomeric Allelic Imbalance Indicates Defective DNA Repair And Sensitivity To DNA-Damaging Agents”. Cancer Discovery, vol 2, no. 4, 2012, pp. 366-375. American Association For Cancer Research (AACR).
  7. Popova, Tatiana et al. “Ploidy And Large-Scale Genomic Instability Consistently Identify Basal-Like Breast Carcinomas With BRCA1/2 Inactivation”. Cancer Research, vol 72, no. 21, 2012, pp. 5454-5462. American Association For Cancer Research (AACR).
  8. Yates, Melinda. et al. “Next Generation Sequencing Of Brca1/2 In High Grade Ovarian Tumors Expands Brca Defects Beyond Germline Mutations”. Annals Of Oncology, vol 25, 2014, p. iv308. Elsevier BV.
  9. The Cancer Genome Atlas Research Network. “Integrated Genomic Analyses Of Ovarian Carcinoma”. Nature, vol 474, no. 7353, 2011, pp. 609-615. Springer Science and Business Media LLC.
  10. Miller, Rowan E. et al. “ESMO Recommendations On Predictive Biomarker Testing For Homologous Recombination Deficiency And PARP Inhibitor Benefit In Ovarian Cancer”. Annals Of Oncology, vol 31, no. 12, 2020, pp. 1606-1622. Elsevier BV.
  11. Tew, William P. et al. “PARP Inhibitors In The Management Of Ovarian Cancer: ASCO Guideline”. Journal Of Clinical Oncology, vol 38, no. 30, 2020, pp. 3468-3493. American Society Of Clinical Oncology (ASCO).