MyChoice is the only HRD test with Level of Evidence 1A, prospectively validated in Phase III studies

At the forefront of ovarian cancer diagnostics, MyChoice stands as the only Homologous Recombination Deficiency (HRD) test prospectively validated with Level of Evidence 1A in Phase III studies for first-line ovarian cancer treatment. Our commitment to precision medicine is reflected in the robust long-term data confirming that MyChoice testing significantly improves survival outcomes for patients with newly diagnosed advanced ovarian cancer.^1,2

ESGO-ESMO-ESP consensus
The European Society of Gynaecological Oncology (ESGO), the European Society for Medical Oncology (ESMO), and the European Society of Pathology (ESP) convened a consensus conference in June 2022 to address critical issues in ovarian cancer management. With 44 experts from Europe with representation from Asia and the USA, the panel covered topics spanning pathology, molecular biology, early, advanced and recurrent disease. The consensus was recently published in Annals of Oncology.3

In this post, we would like to focus your attention on the consensus recommendations, voting outcomes, and the underlying evidence concerning the crucial question: “Which molecular and genomic tests should be conducted at the time of diagnosis to serve as prognostic or predictive markers for high-grade tubo-ovarian carcinoma?“

Recommendations:

R 1.1: An adequate surgical specimen or image-guided biopsy of treatment-naïve tumour is the preferred sample for diagnosis and molecular testing [IV, A].
Consensus: 100% (41) yes, 0% (0) no, 0% (0) abstain (41 voters)

R 1.2: In all cases, the sample should contain a sufficient number of tumour cells (preferably ≥30%). A cell block from peritoneal or pleural effusions may be used for molecular analysis [IV, B].
Consensus: 97.6% (40) yes, 2.4% (1) no, 0% (0) abstain (41 voters)

R 1.3: BRCA-mut (germline and/or somatic) testing is recommended at diagnosis for patients with high-grade non-mucinous tubo-ovarian carcinoma regardless of stage [I, A].
Consensus: 98% (39) yes, 3% (1) no, 0% (0) abstain (40 voters)

R 1.4: Routine tumour testing for non-BRCA homologous recombination gene mutations is not required; however, it should be encouraged in the research setting [IV, B].
Consensus: 100% (40) yes, 0% (0) no, 0% (0) abstain (40 voters)

R 1.5: Genomic instability tests are recommended in patients with BRCA wild-type (wt) high-grade non-mucinous International Federation of Gynecology and   Obstetrics (FIGO) stage III-IV tubo-ovarian carcinoma at diagnosis as this provides useful predictive information for first-line maintenance therapy   decisions [I, A].
Consensus: 100% (40) yes, 0% (0) no, 0% (0) abstain (40 voters)

R 1.6: A genomic instability test that has been clinically validated in large cohorts  [III, B] or, preferably, phase III trials should be used [I, A].
Consensus: 100% (40) yes, 0% (0) no, 0% (0) abstain (40 voters)

R 1.7: There are no validated predictive markers of primary resistance to platinum or PARPis at diagnosis and none can be recommended at present [IV, A].
Consensus: 100% (40) yes, 0% (0) no, 0% (0) abstain (40 voters)

R 1.8: General population screening for tubo-ovarian carcinoma cannot be recommended because screening does not reduce cancer deaths [I, E].
Consensus: 100% (40) yes, 0% (0) no, 0% (0) abstain (40 voters)

R 1.9: CA-125 with or without HE4 should not be used alone to differentiate between benign, borderline and malignant ovarian tumours [IV, D].
Consensus: 97.6% (40) yes, 0% (0) no, 2.4% (1) abstain (41 voters)

Aligning with global expert consensus
Following the ESGO-ESMO-ESP consensus guideline R 1.6, MyChoice is the only  HRD test which was prospectively validated in Phase III studies^1,2,4. This adherence to the highest level of evidence (Level of Evidence 1 A) ensures that MyChoice provides the most reliable information for first-line maintenance therapy decisions, reinforcing our dedication to evidence-based precision diagnostics. Other HRD tests rely only on retrospective clinical validation based on outcome data from Phase III studies.

In line with the ESGO-ESMO-ESP consensus, MyChoice sample requirements ensure that every sample meets the highest standards for molecular analysis. Adhering to guideline R 1.2, we require a sufficient number of tumor cells (preferably ≥30%) in all samples, to deliver accurate and reliable results.

Rapid results for timely decisions with MyChoice
MyChoice combines tumor BRCA1 and BRCA2 testing along with Genomic Instability Score for the most comprehensive HRD status assessment. Understanding the critical nature of time in cancer treatment, MyChoice delivers results within 2-3 weeks. This enables healthcare professionals to make informed, timely treatment decisions, ensuring the best possible outcomes for patients.

The distinctive validation and widespread global adoption of MyChoice with local testing in several countries underscore its reliability and efficacy in guiding clinical decisions. It is recognized as a leading diagnostic tool in the management of ovarian cancer, trusted by healthcare professionals around the world. MyChoice is the only FDA-approved tumor test to determine HRD status with two individual methods: BRCA 1/2 status and genomic instability status.

Discover the MyChoice Advantage
We invite you to explore the significance of a prospectively validated test and how it can transform the management of ovarian cancer. For more information on MyChoice and to understand the full scope of its benefits, please visit our homepage.

References:
1. Ray-Coquard I. et al. Annals of Oncology 2023
2. Gonzalez-Martin, A. et al. European Journal of Cancer 2023
3. Ledermann J.A. et al. Annals of Oncology 2024
4. Coleman, R. L. et al. New England Journal of Medicine, 2019