^
    1d
    Mismatch Repair (MMR) and Homologous Recombination (HR) Deficiency: Real-Life Applications of biomarkers for complementary approaches in Epithelial Ovarian Cancer (AIOM 2024)
    HRD genomic instability tests and multigene panel assessments serve as synergistic tools in EOC clinical settings, proving essential for identifying patients likely to benefit from PARPi therapy. These tools also enhance the detection of HRR and MMR gene variants, aiding in preventive care. Further investigations into the genetic profiles of HRD-negative tumors are crucial for advancing cancer risk management and developing novel therapeutic avenues.
    Clinical • Mismatch repair • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MLH1 (MutL homolog 1) • PMS2 (PMS1 protein homolog 2) • BRCA (Breast cancer early onset) • CHEK2 (Checkpoint kinase 2) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • MUTYH (MutY homolog)
    |
    BRCA2 mutation • BRCA1 mutation • HRD • BRCA wild-type
    |
    Myriad myChoice® CDx
    5d
    Validation of a Homologous Recombination Deficiency (HRD) Assay for Use in Combination with Comprehensive Genomic Profiling (CGP) Testing (AMP 2024)
    The TruSight Oncology 500 comprehensive solid tumor next-generation sequencing panel with HRD assay demonstrated a high degree of sensitivity and specificity for deployment in a clinical setting.
    Combination therapy • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
    |
    HRD
    |
    Myriad myChoice® CDx • TruSight Oncology 500 Assay • TruSight Oncology 500 HRD Assay
    5d
    Comparison of Ovarian Tumor Homologous Recombination Deficiency (HRD) Status Generated from the Illumina TruSight Oncology 500 (TSO500) High-Throughput HRD Assay to the Myriad myChoice CDx Assay (AMP 2024)
    The FDA (US Food and Drug Administration) has approved olaparib as a front-line maintenance therapy in combination with bevacizumab for patients with newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer with HRD+ status. We have demonstrated that the TSO500-HRD assay can accurately determine HRD status in ovarian tumors.
    BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
    |
    BRCA2 mutation • BRCA1 mutation • HRD
    |
    Myriad myChoice® CDx • TruSight Oncology 500 Assay • TruSight Oncology 500 HRD Assay
    |
    Avastin (bevacizumab) • Lynparza (olaparib)
    2ms
    HOTT: Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer (clinicaltrials.gov)
    P3; Trial completion date: Aug 2038 --> Aug 2034 | Trial primary completion date: Aug 2033 --> Aug 2029
    Trial completion date • Trial primary completion date • Surgery
    |
    Myriad myChoice® CDx
    |
    cisplatin • Zejula (niraparib)
    3ms
    Factors associated with an inconclusive result from commercial homologous recombination deficiency testing in ovarian cancer. (PubMed, Cancer)
    Surgical tissue was more likely to yield a conclusive HRD test result versus other sources of epithelial ovarian cancer tissue acquisition. When feasible, laparoscopic biopsy before initiation of neoadjuvant chemotherapy may increase the likelihood of obtaining interpretable HRD test results.
    Journal • PARP Biomarker • BRCA Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
    |
    Myriad myChoice® CDx
    4ms
    Pregnancy and miscarriage in epithelial ovarian cancer (EOC) patients harboring mutational signature of homologous recombination deficiency (HRD) (ESMO 2024)
    Our data suggested that pregnancy in EOC patients with HRD positive tumors is associated with increased incidence of miscarriage. Prospective validation of these findings is required. Meanwhile, oncofertility counseling, and a more in-depth assessment of risk factors, could be proposed to optimize abortion risk-management and improve fetal and obstetric outcomes.
    Clinical • BRCA Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • RAD51 (RAD51 Homolog A)
    |
    BRCA2 mutation • BRCA1 mutation • HRD
    |
    Myriad myChoice® CDx
    4ms
    Beyond HRD status: Unraveling genetic variants impacting PARP inhibitor sensitivity in advanced ovarian cancer (ESMO 2024)
    Our findings highlight the complexity of PARPi response in AOC and underscore the importance of exploring somatic variants beyond HRD status. Further investigation into exon 11 variants of BRCA1 and the potential role of combination treatment is warranted.
    PARP Biomarker • BRCA Biomarker • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • HRD (Homologous Recombination Deficiency)
    |
    HRD
    |
    Myriad myChoice® CDx • TruSight Oncology 500 Assay
    |
    Avastin (bevacizumab) • Zejula (niraparib)
    4ms
    Pan-cancer homologous recombination deficiency (HRD) evaluation in patients enrolled in a routine molecular screening program (ESMO 2024)
    In this pan-cancer cohort of patients, HRD-high scores were present across multiple histologies, supporting its potential clinical use as a tumor-agnostic biomarker and as guidance for treatment options.
    Clinical • BRCA Biomarker • Pan tumor
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
    |
    HRD
    |
    Myriad myChoice® CDx
    4ms
    Association of RAD51 and efficacy outcomes in patients with HER2-negative breast cancer (BC) and homologous recombination deficiency (HRD): Post-hoc analysis of the GeparOla trial (ESMO 2024)
    Patients received paclitaxel (P) plus olaparib or P plus carboplatin, both followed by epirubicin/cyclophosphamide. In a pre-selected HRD population, RAD51 low tumors had a significantly higher pCR rate than RAD51 high tumors under platinum or PARPi-based therapies. This finding underscores the potential of RAD51 to tailor treatment strategies and to improve patient selection for future clinical trials.
    Retrospective data • Clinical • PARP Biomarker • BRCA Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • RAD51 (RAD51 Homolog A)
    |
    HER-2 negative • HRD • BRCA mutation
    |
    Myriad myChoice® CDx
    |
    Lynparza (olaparib) • carboplatin • paclitaxel • cyclophosphamide • epirubicin
    5ms
    In-House Testing for Homologous Recombination Deficiency (HRD) in Mexican Patients with High-Grade Serous Ovarian Cancer (AMP Europe 2024)
    In our preliminary validation cohor t, we observed a 90% concordance rate between assays, consistent with the results of other series (81.6% to 87.8%). When applying the AmoyDX HRD focus panel in HGSOC, we detected HRD positivity in 48.22% of tumors, similar with the incidences reported in PAOLA1 (48%), PRIMA (50.9%), and VELIA (50.1%) trials. While the global prevalence of BRCA1/2 alterations in ovarian cancer ranges from 20% to 25%, we found that 32% of positive cases in our series exhibited gene variants consistent with previous reports of BRCA variant frequencies in Mexican patients.
    Clinical • PARP Biomarker • BRCA Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    Myriad myChoice® CDx • AmoyDx® HRD Focus Panel
    5ms
    Spatial characterization of CD8+ tumour infiltrating lymphocytes in homologous recombination deficient and proficient high-grade ovarian carcinomas (ECP 2024)
    Homologous recombination deficient carcinomas are correlated with high levels of intratumoural-CD8 lymphocytes, showing and therefore with an immune-infiltrated immunophenotype. Manual or computational-assisted morphological immunophenotyping of highgrade ovarian cancers could emerge as a potential surrogate biomarker for detecting those cases with high probability of harbouring HRD deficiency.
    Tumor-infiltrating lymphocyte • Tumor mutational burden • PARP Biomarker • BRCA Biomarker
    |
    TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • CD8 (cluster of differentiation 8)
    |
    BRCA2 mutation • BRCA1 mutation • HRD
    |
    Myriad myChoice® CDx
    5ms
    Prospects for HBOC treatment in gynecology (JBCS 2024)
    Under the keyword "Gene Awareness, " our hospital aims to provide team medical care that provides comprehensive support to clients suspected of having hereditary tumors and their families through close cooperation between the genetic medical department and each medical department. Joint Symposium
    PARP Biomarker • BRCA Biomarker • BRCA Companion diagnostic • PARP Companion diagnostic
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
    |
    Myriad myChoice® CDx
    6ms
    Homologous recombination deficiency should be tested for in patients with advanced stage high-grade serous ovarian cancer aged 70 years and over. (PubMed, Gynecol Oncol)
    HRD frequency was similar in participants aged < 70 and ≥ 70 years (35% vs 31%) when the contribution of gBRCA was excluded; rates of sBRCA PVs were also similar (8% v 10%), thus underscoring the importance of HRD and BRCA testing at diagnosis in older patients with advanced HGSC given the therapeutic implications.
    Journal • BRCA Biomarker • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    BRACAnalysis CDx™ • Myriad myChoice® CDx
    6ms
    QIAGEN and Myriad Genetics develop distributable homologous recombination deficiency test for global research and companion diagnostics applications (Myriad Genetics Press Release)
    "QIAGEN...and Myriad Genetics...announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status. This next-generation sequencing (NGS) test aims to support research into personalized medicine in multiple solid tumor types, including ovarian cancer and is expected to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners. The project builds on the recently announced master collaboration agreement between the two companies."
    Licensing / partnership
    |
    Myriad myChoice® CDx
    6ms
    Harmonization of homologous recombination deficiency testing in ovarian cancer: Results from the MITO16A/MaNGO-OV2 trial. (PubMed, Eur J Cancer)
    Our data suggest the feasibility of commercial testing for assessing HRD status, with a good concordance with the reference method and association with clinical outcome.
    Journal • BRCA Biomarker
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    Myriad myChoice® CDx • TruSight Oncology 500 Assay • Oncomine™ Comprehensive Assay Plus • SOPHiA DDM HRD Solution • TruSight Oncology 500 HRD Assay
    6ms
    Molecular Residual Disease (MRD) study and multiple RiskScore studies among seven new datasets to be shared by Myriad and collaborators (Myriad Genetics Press Release)
    "Myriad Genetics...and its collaborators will share data from seven studies at the 2024 ASCO Annual Meeting. Three studies led by Myriad focus on breast cancer risk assessment, and four additional studies will be shared by collaborators that will cover the company’s Precise™ MRD Test, MyChoice® CDx HRD Companion Diagnostic Test, and the Myriad Collaborative Research Registry™ (MCRR)."
    Licensing / partnership
    |
    Myriad myChoice® CDx • Precise™ MRD
    6ms
    Real-life data for HRD testing from the only French platform using the Myriad MyChoice test (ESMO-GC 2024)
    Background: HRD is correlated with increased survival of patients with advanced ovarian cancer treated with maintenance olaparib + bevacizumab. The Myriad MyChoice test allows the analysis of BRCA variations and the GIS at the same time for a complete and faster molecular diagnosis, which is suitable for the majority of patients. Moreover, the thorough quality selection of tissue samples during the bioinformatics analysis leads to a strong reliability and a confidence in the results by dramatically reducing the rate of false negative results.
    Clinical • PARP Biomarker • BRCA Biomarker
    |
    TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    Myriad myChoice® CDx
    |
    Avastin (bevacizumab) • Lynparza (olaparib)
    6ms
    Feasibility and cost-effectiveness of genetic counselling for all patients with newly diagnosed ovarian cancer: a single-centre retrospective study. (PubMed)
    Using genetic counselling to consent patients with newly diagnosed ovarian cancer for germline testing fulfils the international gold standard. Subsequent somatic homologous recombination deficiency analysis complements testing and identifies more patients who will benefit from PARP inhibitor maintenance therapy. Contrary to previous health cost model studies, the procedure does not increase testing costs in the Swiss population and does not delay maintenance therapy. Therefore, all patients should be offered a primary germline analysis. The challenge for the future will be to ensure sufficient resources for prompt genetic counselling and germline testing.
    HEOR • Journal • Retrospective data • Cost-effectiveness • Cost effectiveness • PARP Biomarker • BRCA Biomarker
    |
    Myriad myChoice® CDx
    7ms
    Durvalumab (D) + carboplatin/paclitaxel (CP) + bevacizumab (B) followed by D, B + olaparib (O) maintenance (mtx) for newly diagnosed advanced ovarian cancer (AOC) without a tumour BRCA1/BRCA2 mutation (non-tBRCAm): Updated results from DUO-O (ESMO-GC 2024)
    D + CP + B followed by D + B + O mtx continued to improve PFS vs control, including by subgroup; in the non-tBRCAm HRD+ population, median PFS was 45.1 mo, the longest seen for these pts in the first-line setting to date, with an associated favourable OS trend. PFS2 was improved in both the non-tBRCAm HRD+ and non-tBRCAm ITT populations.
    Clinical • PD(L)-1 Biomarker • PARP Biomarker • BRCA Biomarker • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    Myriad myChoice® CDx
    |
    Avastin (bevacizumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • paclitaxel
    7ms
    Combination ATR and PARP Inhibitor (CAPRI): A phase 2 study of ceralasertib plus olaparib in patients with recurrent, platinum-sensitive epithelial ovarian cancer (cohort A). (ASCO 2024)
    C+O was well tolerated and active in pts with platinum sensitive HGSOC warranting further evaluation. Efficacy was seen regardless of the presence of tumor genomic instability.
    P2 data • Clinical • PARP Biomarker • BRCA Biomarker
    |
    BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • ATR (Ataxia telangiectasia and Rad3-related protein) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C)
    |
    Myriad myChoice® CDx
    |
    Lynparza (olaparib) • ceralasertib (AZD6738)
    7ms
    Comprehensive molecular profiling of newly diagnosed advanced, high-grade ovarian cancer: Unveiling BRCA1/2 mutations and genomic instability scores to advocate for public insurance coverage of genetic testing—Insights from the Hellenic Society of Medical Oncology (HeSMO) national program. (ASCO 2024)
    HRD and GIS are vital genomic instability biomarkers in high-grade ovarian cancer. These metrics provide valuable insights into tumor aggressiveness, guiding therapeutic decisions, including the use of PARP inhibitors. In this study of 511 patients from 50 centers across Greece, 48.14% tested positive for HRD, emphasizing PARP inhibitors' significance and suggesting hereditary implications.
    US reimbursement • Reimbursement • PARP Biomarker • BRCA Biomarker • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    Myriad myChoice® CDx
    7ms
    Olaparib Addition to Maintenance Bevacizumab Therapy in Ovarian Carcinoma With BRCA-Like Genomic Aberrations. (PubMed, JAMA Netw Open)
    In this secondary analysis of the PAOLA-1 randomized clinical trial, patients with a BRCA-like tumor, but not those with a non-BRCA-like tumor, had a significantly longer survival after olaparib plus bevacizumab treatment than placebo plus bevacizumab treatment. Thus, the BRCA1-like classifier could be used as a biomarker for olaparib plus bevacizumab as a maintenance treatment.
    Clinical • Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HRD
    |
    Myriad myChoice® CDx
    |
    Avastin (bevacizumab) • Lynparza (olaparib)
    8ms
    OU-SCC-PI-4G: PARP Inhibition for Gliomas (PI-4G or π4g) (clinicaltrials.gov)
    P2; N=45 --> 15 | Trial completion date: Nov 2024 --> Feb 2024 | Active, not recruiting --> Terminated; Funder terminated funding.
    Trial completion date • Enrollment change • Trial termination
    |
    Myriad myChoice® CDx
    |
    Zejula (niraparib)
    8ms
    High Concordance of Different Assays in the Determination of Homologous Recombination Deficiency-Associated Genomic Instability in Ovarian Cancer. (PubMed, JCO Precis Oncol)
    Assays for GI assessment not only show a high concordance with each other but also in correlation with Myriad myChoice. Thus, almost all of the assays included here can be used effectively to assess HRD-associated GI in the clinical setting. This is important as PARPi treatment on the basis of these tests is compliant with European Medicines Agency approvals, which are methodologically not test-bound.
    Journal • BRCA Biomarker • PARP Biomarker • Discordant
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
    |
    BRCA2 mutation • BRCA1 mutation • HRD
    |
    Myriad myChoice® CDx • TruSight Oncology 500 Assay • TruSight Oncology 500 HRD Assay
    8ms
    Implementing MyChoice® CDx HRD testing for the Nordics: lessons from 2021 to 2023. (PubMed, Acta Oncol)
    The myChoice® CDx Nordic core facility has been well received among the Nordic countries and provides new insights on the influence of national guidelines on HRD testing. Overall, we experienced an efficient turnaround time and a high fraction of conclusive results. Interestingly, prior somatic BRCA testing is redundant when assessing HRD status through myChoice® CDx test since somatic BRCA screening is already a significant component of the myChoice® CDx test. Thus, it should be considered to omit prior somatic BRCA testing to ensure a rationalised HRD diagnostic flow optimised for clinical use.
    Journal • PARP Biomarker • BRCA Biomarker
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD
    |
    Myriad myChoice® CDx
    8ms
    Clinical evaluation of a low-coverage whole-genome test for detecting homologous recombination deficiency in ovarian cancer. (PubMed, Eur J Cancer)
    The SeqOne assay offers a clinically validated approach to detect HRD.
    Journal
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA wild-type
    |
    Myriad myChoice® CDx
    |
    Avastin (bevacizumab) • Lynparza (olaparib)
    9ms
    HOTT: Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer (clinicaltrials.gov)
    P3; Not yet recruiting --> Recruiting
    Enrollment open
    |
    Myriad myChoice® CDx
    |
    cisplatin • Zejula (niraparib)
    9ms
    Homologous Recombinant Deficiency Does Not Share Morphologic Surrogates of BRCA-mutated High-Grade Serous Carcinoma (USCAP 2024)
    BRCA mutation is one cause of HRD and appears that SET morphology associated with HGSC is unique to BRCA-mutation and not under the umbrella of other causes and effects of HRD. HRD in HGSC may produce its own molecular surrogate that is yet to be discovered. Definitive determination of which platform is superior for clinical validation of HRD assessment as a surrogate to Myriad MyChoiceDX gold standard requires matched analysis against Myriad and patient's progression free survival.
    BRCA Biomarker
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA wild-type • BRCA mutation
    |
    Myriad myChoice® CDx • Oncomine™ Comprehensive Assay Plus
    9ms
    Homologous Recombination Deficiency (HRD) In Primary Advanced Stage And Recurrent P53 Abnormal Endometrial Carcinoma (ESGO 2024)
    Further investigation of HRD and EC-specific GIS cut-off value are highly warranted and may help to improve outcome in this specific EC subgroup. Patients with p53abn tumors may benefit from PARP inhibition and HRD testing may provide key information for patient selection.
    Tumor mutational burden • PARP Biomarker • BRCA Biomarker • Metastases
    |
    TMB (Tumor Mutational Burden) • HRD (Homologous Recombination Deficiency) • POLE (DNA Polymerase Epsilon) • BRCA (Breast cancer early onset)
    |
    TP53 mutation • HRD • POLE mutation • TMB-L • BRCA mutation
    |
    Myriad myChoice® CDx
    10ms
    Characterization of Epithelial Ovarian Cancer Based on Multi-Gene Tumour Testing and Homologous RecomBinatiOn Deficiency (HRD) Testing (COMBO) (SGO 2024)
    Multi-gene NGS tumour testing was capable of identifying all clinically relevant germline variants. Although paired multi-gene tumour-germline testing is required to determine variant origin, over 40% of individuals in this study could have avoided germline testing following negative tumour results. These results suggest that streamlining genetic testing for EOC patients via primary multi-gene tumour testing is possible with further investigation.
    PARP Biomarker • BRCA Biomarker
    |
    TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • STK11 (Serine/threonine kinase 11) • HRD (Homologous Recombination Deficiency) • PALB2 (Partner and localizer of BRCA2) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • PMS2 (PMS1 protein homolog 2) • BRCA (Breast cancer early onset) • CDH1 (Cadherin 1) • CHEK2 (Checkpoint kinase 2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • POLD1 (DNA Polymerase Delta 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • EPCAM (Epithelial cell adhesion molecule) • BARD1 (BRCA1 Associated RING Domain 1)
    |
    HRD
    |
    Myriad myChoice® CDx
    10ms
    Clinical and molecular determinants of response to maintenance olaparib for primary and recurrent epithelial ovarian carcinoma (SGO 2024)
    The incidence of ST response to maintenance olaparib is high and appears to be modulated by maintenance sequence (primary vs recurrent therapy). Response to most recent chemotherapy could be incorporated into prospective data as a surrogate for predicting response to PARP inhibitors. Efforts to increase utilization of PARP inhibitor therapy in the primary maintenance setting are warranted.
    Clinical • PARP Biomarker • BRCA Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HRD • HRD + BRCA1 mutation • BRCA mutation
    |
    Myriad myChoice® CDx
    |
    Lynparza (olaparib)
    10ms
    Homologous recombination status in BRCA wild-type patients as a predictor of disease volume and surgical outcome in patients with high-grade serous ovarian cancer (SGO 2024)
    In patients with advanced ovarian cancer who are BRCA WT, HRD does not seem to predict cytoreductive surgical outcome or pre-treatment disease volume, although patients with HRI were less likely to be offered PCS. Larger, prospective cohort with HR status on all comers with HGSOC, will help to determine the significance of HR status when deciding on PCS or ICS.
    Clinical
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA wild-type
    |
    Myriad myChoice® CDx
    10ms
    MEDx HRDetectCDx Predicts The Response Of Newly Diagnosed Advanced Ovarian Cancer Patients In China To First-Line Maintenance Treatment With Niraparib (ESGO 2024)
    39). Conclusion The MEDx HRDetectCDx demonstrated high consistency with Myriad test and was prospectively validated for predictive value in 1L maintenance therapy with niraparib in the real-world setting.
    Clinical • PARP Biomarker • BRCA Biomarker • Metastases
    |
    HRD (Homologous Recombination Deficiency)
    |
    HRD
    |
    Myriad myChoice® CDx
    |
    Zejula (niraparib)
    10ms
    Homologous Recombination Deficiency (HRD) In Primary Advanced Stage And Recurrent P53 Abnormal Endometrial Carcinoma (ESGO 2024)
    Further investigation of HRD and EC-specific GIS cut-off value are highly warranted and may help to improve outcome in this specific EC subgroup. Patients with p53abn tumors may benefit from PARP inhibition and HRD testing may provide key information for patient selection.
    Tumor mutational burden • PARP Biomarker • BRCA Biomarker • Metastases
    |
    TMB (Tumor Mutational Burden) • HRD (Homologous Recombination Deficiency) • POLE (DNA Polymerase Epsilon) • BRCA (Breast cancer early onset)
    |
    TP53 mutation • HRD • POLE mutation • TMB-L • BRCA mutation
    |
    Myriad myChoice® CDx
    10ms
    GREAT: A Unique Cohort Of 1500 Advanced Ovarian Cancer (AOC) Patients Treated In Real Life With Prospective Biomarkers Including Tumor BRCA And HRD, And Tumor Collection, A GINECO Study. (ESGO 2024)
    GREAT cohort: Main clinical and tumor biological patient characteristicsConclusion Characteristics and treatment of the 1507 pts included in the real-life GREAT prospective study are representative of the standard AOC population. The clinically and biologically annotated GREAT cohort with collection of tumor samples offers a unique opportunity for evaluating new tumor targets for future drug development.
    Clinical • BRCA Biomarker • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • ARID1A (AT-rich interaction domain 1A) • PALB2 (Partner and localizer of BRCA2) • CDK12 (Cyclin dependent kinase 12) • BRCA (Breast cancer early onset) • CHEK2 (Checkpoint kinase 2) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin))
    |
    HRD • BRCA mutation
    |
    Myriad myChoice® CDx
    10ms
    Myriad myChoice® CDx: Indication expansion (e.g. Breast and Prostate) in 2H 2025 (Myriad Genetics)
    J.P. Morgan 42nd Annual Healthcare Conference Presentation
    Clinical
    |
    Myriad myChoice® CDx
    10ms
    Real-World Concordance between Germline and Tumour BRCA1/2 Status in Epithelial Ovarian Cancer. (PubMed)
    The myChoice CDx was able to detect most germline BRCA1/2 pathogenic variants in tumour DNA, although a proportion of pathogenic large rearrangements were not reported. If Myriad's myChoice CDx is used for tumour BRCA1/2 testing, our data supports a testing strategy of germline and tumour BRCA1/2 testing in all patients diagnosed with epithelial ovarian cancer aged < 79 years old, with germline BRCA1/2 testing only necessary for patients aged ≥ 80 years old with a tumour BRCA1/2 pathogenic variant.
    Real-world evidence • Journal • BRCA Biomarker • BRCA Companion diagnostic • Real-world • Discordant
    |
    Myriad myChoice® CDx
    10ms
    OU-SCC-PI-4G: PARP Inhibition for Gliomas (PI-4G or π4g) (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Nov 2024 | Trial primary completion date: Jun 2025 --> Nov 2023
    Trial completion date • Trial primary completion date • Enrollment closed
    |
    Myriad myChoice® CDx
    |
    Zejula (niraparib)
    10ms
    Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer (clinicaltrials.gov)
    P1/2; Trial completion date: May 2025 --> Nov 2026 | Trial primary completion date: May 2025 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    BRCA (Breast cancer early onset)
    |
    BRCA wild-type
    |
    Myriad myChoice® CDx
    |
    Zejula (niraparib)
    11ms
    Tumour-based Mutational Profiles Predict Visceral Metastasis Outcome and Early Death in Prostate Cancer Patients. (PubMed, Eur Urol Oncol)
    Mutations in the TP53 gene and genes (APC/CTNNB1) related to the Wnt pathway are associated with metastatic visceral dissemination and early death. These genomic alterations could be considered as markers to identify prostate cancer patients at a high risk of life-threatening disease who might benefit from more intensified treatment or new targeted therapies.
    Journal • BRCA Biomarker
    |
    TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency) • APC (APC Regulator Of WNT Signaling Pathway)
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    TP53 mutation • HRD • CTNNB1 mutation
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    Myriad myChoice® CDx
    11ms
    Repair-assisted damage detection as a potential predictive biomarker for immunotherapy response in ovarian cancer (SGO 2024)
    RADD demonstrates the ability to determine a quantitative analysis of DNA damage and repair in ovarian cancer samples. Considering its rapid turnaround time and correlation with HR status, RADD has potential use in determining clinical trial candidates stratified by HR status. Additionally, RADD correlates with known predictive biomarker CD39 for response with immunotherapy.
    IO biomarker
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    HRD (Homologous Recombination Deficiency) • CSF2 (Colony stimulating factor 2) • TGFB1 (Transforming Growth Factor Beta 1) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1) • TGFB2 (Transforming Growth Factor Beta 2)
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    CSF2 expression • ENTPD1 expression
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    Myriad myChoice® CDx
    11ms
    OU-SCC-PI-4G: PARP Inhibition for Gliomas (PI-4G or π4g) (clinicaltrials.gov)
    P2; N=45; Recruiting; Sponsor:University of Oklahoma
    Trial completion date • Trial primary completion date
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    Myriad myChoice® CDx
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    Zejula (niraparib)