MyChoice Ovarian Cancer Prognostic Test

Informing treatment decisions for patients with ovarian cancer

MyChoice® gives you comprehensive clarity when making ovarian cancer treatment decisions.

Knowing HRD status is key to determining ovarian cancer treatment options

Homologous recombination deficiency (HRD) is present in approximately 48% of ovarian cancer tumors,1 most often resulting from a mutation found only within the tumor. Some causes of HRD are well established, while others remain unknown.2,3,4

Determining HRD status for ovarian cancer patients can help provide information on the magnitude of benefit for PARP inhibitor therapy, which provide optimal outcomes to HRD positive patients.

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.5,6
  • HR pathway gene mutations other than BRCA1 and BRCA2 are rare, and it is unclear if they are connected to HRD.7,8

Unidentified causes of HRD will be missed.

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 determines HRD status in multiple ways for comprehensive results

MyChoice 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

The gold-standard HRD test – what to expect

Accurate

MyChoice identifies 34% more tumors with HRD than tests that use %LOH alone.5

Fast

Clinicians will get a MyChoice result back within 2–3 weeks after the pathology lab receives the sample.

Actionable

Easy-to-read MyChoice results with GIS, BRCA1/BRCA2 interpretation, and combined results to inform treatment decisions.

Trusted

FDA, PMDA, ASCO, NCCN and ESMO trust MyChoice.9-12

The most comprehensive and accurate HRD test for treatment decisions within days

It has been shown that by using the methods below, MyChoice 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 analyses BRCA1/2, to include sequence variance and large rearrangements, capturing 5% more than other platforms that do not have this technology.5,13,14

Comprehensive clinical validation

MyChoice is the only HRD test prospectively validated in three phase III studies for use in first-line treatment of ovarian cancer.14-18 Robust long-term data confirm MyChoice testing improves survival in patients with newly diagnosed advanced ovarian cancer who receive first-line treatment.14-18

PAOLA-1 n= 806

PRIMA n= 733

VELIA n= 1,140

Real-world validation in local labs

MyChoice is validated for decentralized evaluation of HRD in academic local molecular pathology laboratories, following the results of a real-world validation study.19 This means wider access to precision medicine for patients with ovarian cancer worldwide.

Learn more about the study below or download the clinical summary.

 

Watch our ESMO 2023 Industry Satellite Symposium now

Accessing cutting-edge precision oncology through local testing

  • How to implement local LoE1A HRD testing: experience of a center of excellence
  • Optimal HRD ovarian cancer treatment – Are genomic tests interchangeable?
  • Prospective real world data support prognostic and predictive second-generation breast cancer signature performance

Not all HRD tests are alike

Trusted worldwide

MyChoice CDx is named in guidelines and is the only HRD test with level of evidence 1A (LoE1A) validated in multiple phase III studies for first-line PARP inhibitor treatment in ovarian cancer.14-18

Recommended by NCCN12

Somatic testing should prioritize identification of molecular alterations that inform the use of effective interventions. This includes assessing BRCA1/2, loss of heterozygosity (LOH), or homologous recombination deficiency (HRD) status in the absence of a germline BRCA mutation.

Recommended by ASCO9

Myriad MyChoice CDx is 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.

Recommended by ESMO10

Validated scar-based HRD tests can be used to guide PARP inhibitor treatment. ESMO recognizes MyChoice CDx is the only scar based HRD test validated in the first-line maintenance setting.

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)

Note that for local testing, each MyChoice performing lab can provide its own reports, which may look different than the original report shown here.

How to bring MyChoice HRD testing to your practice

MyChoice HRD Companion Diagnostic Test is available in many countries all over the world either via local labs in your country or via Myriad Genetics’ central laboratory in Salt Lake City, USA.

Please find further information at the link below on availability in different regions and links to relevant information and forms.

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.
  2. Da Cunha Colombo Bonadio, Renata Rodrigues, et al. “Homologous Recombination Deficiency in Ovarian Cancer: A Review of Its Epidemiology and Management.” Clinics, 73(Suppl 1), 2018, p. e450s.
  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.
  4. Konstantinopoulos, Panagiotis A., et al. “Homologous Recombination Deficiency: Exploiting the Fundamental Vulnerability of Ovarian Cancer.” Cancer Discovery, vol. 5, no. 11, 2015, pp. 1137–1154.
  5. Timms, Kirsten M, et al. “Comparison of Genomic Instability Test Scores Used for Predicting PARP Activity in Ovarian Cancer.” Journal of Clinical Oncology, vol. 38, no. 15_suppl, 2020, pp. 1586–1586.
  6. Baldwin, Rae L. et al. “BRCA1 Promoter Region Hypermethylation in Ovarian Carcinoma: A Population-based Study.” Cancer Research, vol. 60, no. 19, 2000, pp. 5329-5333.
    Norquist, Barbara M. et al. “Inherited Mutations In Women With Ovarian Carcinoma”. JAMA Oncology, vol 2, no. 4, 2016, p. 482.
  7. The Cancer Genome Atlas Research Network. “Integrated Genomic Analyses Of Ovarian Carcinoma”. Nature, vol 474, no. 7353, 2011, pp. 609-615.
  8. Weichert, W et al. “216 An Evaluation Of The Performance Of Molecular Assays To Identify Homologous Recombination Deficiency-Positive Tumours In Ovarian Cancer”. Late Breaking Abstracts, 2021.
  9. Tew, William P., et al. “Poly(ADP-Ribose) Polymerase Inhibitors in the Management of Ovarian Cancer: ASCO Guideline Rapid Recommendation Update.” Journal of Clinical Oncology, vol. 40, no. 33, 2022, pp. 3878–3881.
  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.
  11. Cristescu, Razvan et al. “428 Genomic Instability Metric Concordance Between Oncoscan™, Cytosnp And An Fda-Approved HRD Test”. Translational Research, 2020.
  12. National Comprehensive Cancer Network. Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer. Version 1.2023.
  13. https://info.foundationmedicine.com/hubfs/FMI%20Labels/FoundationOne_CDx_Label_Technical_Info.pdf
  14. 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, vol. 34, no. 8, 2023, pp. 681–692.
  15. 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.
  16. González-Martín, Antonio, et al. “Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.” New England Journal of Medicine, vol. 381, no. 25, 2019, pp. 2391–2402.
  17. 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, vol. 189, 2023, p. 112908.
  18. Coleman, Robert L., et al. “Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer.” New England Journal of Medicine, vol. 381, no. 25, 2019, pp. 2403–2415.
  19. Denkert, Carsten, et al. “Homologous Recombination Deficiency as an Ovarian Cancer Biomarker in a Real-World Cohort.” The Journal of Molecular Diagnostics, vol. 24, no. 12, 2022, pp. 1254-1263.