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TEST:
AmoyDx® HRD Focus Panel

Type:
Laboratory Developed Test
Related tests:
4ms
Concordance between Three Homologous Recombination Deficiency (HRD) Assays in Patients with High-Grade Epithelial Ovarian Cancer. (PubMed, Cancers (Basel))
False-positive rates were 31.6% (6/19) for AmoyDx GI status and 31.9% (7/22) for OncoScanâ„¢, while false-negative rates were 0% (0/28, AmoyDx) and 11.1% (2/18, OncoScanâ„¢) compared with the Myriad MyChoice GI status. While substantial concordance between Myriad MyChoice and alternative assays was demonstrated, prospective validation of the analytical performance and clinical relevance of these assays is warranted.
Journal • Discordant
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HRD (Homologous Recombination Deficiency)
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HRD
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Myriad myChoice® CDx • AmoyDx® HRD Focus Panel
4ms
A Benchmark of In-House Homologous Recombination Repair Deficiency Testing Solutions for High-Grade Serous Ovarian Cancer Diagnosis. (PubMed, Diagnostics (Basel))
Our data shows that the implementation of in-house HRD testing in diagnostic laboratories is technically feasible and can be reliably performed with commercial assays. Also, the turnaround time is compatible with clinical needs, making it an ideal alternative to offer to a broader number of patients while maintaining high-quality standards at more accessible price tiers.
Journal • PARP Biomarker
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HRD (Homologous Recombination Deficiency)
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HRD
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Myriad myChoice® CDx • AmoyDx® HRD Focus Panel • SOPHiA DDM HRD Solution
5ms
Moving towards homologous recombination deficiency (HRD) analysis standardization: evaluation of reference materials across leading HRD assays (AMP 2023)
"We developed the Seraseq HRD reference materials to meet the needs of laboratories looking to analyze HRD in cancer patient samples. The HRD status of each material was evaluated using several assays using different measurement approaches. Although the materials showed similar trends and concordance among formats, there was variability in GIS across the methods tested."
ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D)
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HRD
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TruSight Oncology 500 Assay • AmoyDx® HRD Focus Panel • OncoScan™ CNV Assay • TruSight Oncology 500 HRD Assay
6ms
Molecular characterization of biliary tract cancer at a single comprehensive cancer center focusing on DNA damage repair genes. (DGHO 2023)
Pathogenic alterations in DDR pathway genes were seen in 13.5% of the cases studied. DDR-deficient BTC patients showed a trend for better OS and TTE representing a potential subgroup that could benefit from targeted treatment strategies, like PARP-inhibitors. and more prospective data are needed.
PARP Biomarker
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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TP53 mutation • KRAS mutation • BRAF mutation • PIK3CA mutation • FGFR2 mutation • FGFR2 fusion
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AmoyDx® HRD Focus Panel • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit
8ms
Amoy Diagnostics, AstraZeneca partner to advance PARP inhibitor CDx for maintenance indication (Genomeweb)
"Chinese diagnostics firm Amoy Diagnostics said...that it has entered into a collaboration agreement with AstraZeneca to advance its AmoyDx HRD Complete Panel as a companion diagnostic for the pharma firm's PARP inhibitor Lynparza (olaparib)."
Licensing / partnership
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AmoyDx® HRD Focus Panel
8ms
HRD status of patients with early stage non-small cell lung cancer (ESMO 2023)
Preliminary functional experiments in HRP (HR proficient, n=5) and HRD (n=4) PDX and organoids (n=3 and n=3 for HRD and HRP respectively) indicate that HRD tumors present low RAD51 foci count (p=0.03 after damage induction) and favorable response to Olaparib and CDDP. Conclusions These data suggest that homologous recombination may be deficient in a substantial proportion of early-stage NSCLC patients, supporting the potential use of PARPi in HRD patients in the adjuvant or maintenance setting.
Clinical • PARP Biomarker • BRCA Biomarker
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TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • PALB2 (Partner and localizer of BRCA2) • CHEK2 (Checkpoint kinase 2) • RAD51 (RAD51 Homolog A) • RAD50 (RAD50 Double Strand Break Repair Protein) • CHEK1 (Checkpoint kinase 1)
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BRCA2 mutation • BRCA1 mutation • HRD • ATM mutation • PALB2 mutation • CHEK2 mutation • HRD + BRCA1 mutation • RAD50 mutation • CHEK1 mutation • CHEK1 expression
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AmoyDx® HRD Focus Panel
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Lynparza (olaparib)
8ms
A novel machine learning based method to detect homozygous deletion of homologous recombination repair (HRR) genes in prostate cancer (ESMO 2023)
Analytical performance was assessed with reference cell lines: specificity with wildtype cell lines, sensitivity with gradient HD-positive cell lines (tumor cellularity: 20%, 30%, 40%, 50%) with varying DNA input (30ng, 50ng, 100ng), reproducibility of intra- and inter-runs, and anti-interference against hemoglobin, triglycerides, xylene, paclitaxel, and ethanol...Conclusions A machine learning based method was successfully developed and adopted in multiple NGS assays to detect HD of HRR genes in PC tissues. It provides a reliable approach to effectively identify PC patients with HRR HD.
PARP Biomarker • Machine learning
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HRD (Homologous Recombination Deficiency)
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AmoyDx® HRD Focus Panel
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paclitaxel
8ms
HRD complete: A novel NGS assay for detecting homologous recombination repair (HRR) gene alterations in prostate cancer (ESMO 2023)
Accuracy of BRCA1/2 SNV/InDel was further verified with 100% concordance with BRCA1/2 kit. Conclusions With high sensitivity and specificity, short TAT and high success rate, the CE marked (CE-IVD) HRD Complete assay provides a robust and reliable test approach to PC patients that may guide them for a better treatment option.
PARP Biomarker • BRCA Biomarker • Next-generation sequencing
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
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AmoyDx® HRD Focus Panel • AmoyDx® BRCA1 and BRCA2 Gene Mutation Detection Kit
8ms
DNA damage repair pathways in biliary tract cancer: A new target for precision medicine? (ESMO 2023)
DDR-deficient BTC patients showed a trend for better OS and TTE representing a potential subgroup that could benefit from targeted treatment strategies, like PARP-inhibitors. Moreover the slight benefit of DDR-mutated BTC under platinum-based therapy supports the hypothesis of better response of DDR-mutated tumours to platinum.
PARP Biomarker
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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TP53 mutation • KRAS mutation • BRAF mutation • PIK3CA mutation • FGFR2 mutation
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AmoyDx® HRD Focus Panel • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit
8ms
Development Of NGS Cancer Panel-based Homologous Recombination Deficiency Test In Epithelial Ovarian Cancer (ESGO 2023)
Using the cut-off value of 42 for a new algorithm, the accordance rate between the two tests was 78.9%.Conclusion We successfully developed NGS cancer panel-based HRD test algorithms. The incorporation of the new algorithm on NGS cancer panels might be useful to identify HRD-positive EOC cases.
BRCA Biomarker • Next-generation sequencing
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
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BRCA2 mutation • BRCA1 mutation • HRD
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AmoyDx® HRD Focus Panel
8ms
HRD Testing of Ovarian Cancer in Routine Practice: What Are We Dealing With? (PubMed, Int J Mol Sci)
The analysis shows that biallelic BRCA alterations had higher GSS compared with those with monoallelic inactivation, consistent with positive HRD status. The study indicates that grades 1-2 of the pathological response caused by chemotherapy affect HRD scores and suggests controlling for tumor purity of 40% or more as a critical factor for GSS measurement.
Journal • BRCA Biomarker
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HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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HRD • BRCA mutation
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AmoyDx® HRD Focus Panel
10ms
Homologous Recombination deficiency classification and PARP inhibitor response of reference-free colorectal cancer samples (EACR 2023)
"HRDirect predictions on tumor-only samples reproduced the expected results with a very low discordance (Cohen's kappa: 0.97).After having confirmed that our tool performs well also on matched CRC organoids, we obtained scores from HRDirect and AmoyDX HRD: both approaches resulted equivalent at predicting the sensitivity of CRC cell lines to PARPi.Both tests were unable to identify HRD in samples characterized by ATM loss, a feature characterized by lack of molecular scars. For this reason, we propose to combine the HRDirect scoring with ATM immunohistochemistry (IHC) analysis to improve the overall HRD prediction.ConclusionOur results highlight that combining HRDirect and ATM IHC can potentiate the identification of HRD tumors, with an immediate translational and clinical impact.This finding results of interest not only for the analysis of clinical samples missing the germline DNA, but also for preclinical models that have been demonstrated to be valuable platforms..."
ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency)
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HRD
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AmoyDx® HRD Focus Panel
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Lynparza (olaparib)
11ms
Resistance mechanism and microenvironment changes after PARPi treatment: Paired analysis of ovarian cancer samples pre and post treatment. (ASCO 2023)
Our small-scale study confirmed that BRCA reversion mutation is one of the important resistance mechanisms of PARPi, and the reversion mutation is located near the germline pathogenic mutation to counteract the reading frame change caused by the frameshift mutation. The up-regulation of B-cell receptor, NK cytotoxic cytokine receptor interaction and other related pathways suggested that PARPi may activate immune response, and the changes in the levels of memory B cells, C7 and neutrophils also confirmed the results above. Epithelial mesenchymal transition induced by CCL18 may also lead to PARPi resistance and activate the NF-κb pathway simultaneously, increasing the inflammatory characteristics of TME.
Tumor mutational burden • PARP Biomarker • BRCA Biomarker
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TMB (Tumor Mutational Burden) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BRCA (Breast cancer early onset) • NGFR (Nerve Growth Factor Receptor) • CCL18 (C-C Motif Chemokine Ligand 18) • ZFHX4 (Zinc Finger Homeobox 4)
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MYC amplification • BRCA mutation • NGFR expression
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AmoyDx® HRD Focus Panel • AmoyDx® Master Panel
1year
Locally Performed HRD Testing for Ovarian Cancer? Yes, We Can! (PubMed, Cancers (Basel))
In addition, to further deepen the mechanisms behind HRD, we analyzed the study cohort by using both a custom NGS panel that analyzed 21 HRR-related genes and FISH analysis to determine the copy numbers of PTEN and EMSY. We found complete concordance in HRD status detected by the Amoy and the Myriad assays, supporting the feasibility of internal HRD testing.
Journal • PARP Biomarker • BRCA Biomarker
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PTEN (Phosphatase and tensin homolog) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • EMSY (EMSY Transcriptional Repressor BRCA2 Interacting)
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HRD
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Myriad myChoice® CDx • AmoyDx® HRD Focus Panel
over1year
Molecular characterization of biliary tract cancers treated at the West German Cancer Center Essen (DKK 2022)
We report a well-characterized cohort of BTC patients analyzed with three molecular assays. The 7% of BTC patients with DDR deficiency might be another subgroup suitable for targeted therapies, i.e. PARP inhibition.
PARP Biomarker
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KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR2 (Fibroblast growth factor receptor 2) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • ARID1A (AT-rich interaction domain 1A) • NRG1 (Neuregulin 1) • BAP1 (BRCA1 Associated Protein 1)
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TP53 mutation • KRAS mutation • PIK3CA mutation • ARID1A mutation • FGFR2 fusion • NRG1 fusion • NRG1 fusion
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AmoyDx® HRD Focus Panel • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit
over1year
Tissue Quality and False-Negative Homologous Repair Deficiency (HRD) Results Might Deprive Patients of Targeted Therapy Benefits (AMP 2022)
Clinical trial outcomes undoubtedly urge companion diagnostics tests' and newly developed HRD assays' optimization. Nonetheless, sample quality is critical for all methods, especially when complex traits, such as HRD, are measured, as shown by our analyses. Sample quality is adversely affected in numerous steps, from surgery to DNA extraction.
Clinical • PARP Biomarker • BRCA Biomarker • BRCA Companion diagnostic • PARP Companion diagnostic
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
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HRD • BRCA mutation
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AmoyDx® HRD Focus Panel
over1year
In-house testing for homologous recombination repair deficiency (HRD) testing in ovarian carcinoma: a feasibility study comparing AmoyDx HRD Focus panel with Myriad myChoiceCDx assay. (PubMed, Pathologica)
All the 36 AmoyDx negative cases were confirmed to be negative by Myriad (negative predictive value, 100%). The concordance of the results with the gold standard Myriad MyChoice CDx assay suggest the feasibility and reliability of HRD testing in diagnostic laboratories with high-throughput NGS platforms and qualified personnel.
Journal • BRCA Biomarker • PARP Biomarker
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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BRCA2 mutation • BRCA1 mutation • HRD • BRCA mutation
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Myriad myChoice® CDx • AmoyDx® HRD Focus Panel
over1year
COMPARISON OF HRD STATUS BEFORE AND AFTER NEOADJUVANT CHEMOTHERAPY IN PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER (IGCS 2022)
"The HRD status of advanced epithelial ovarian cancer patients may be influenced by platinum-based chemotherapy. So, it should be detected by surgical sample after NACT."
Clinical
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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BRCA2 mutation • BRCA1 mutation • HRD • BRCA mutation
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AmoyDx® HRD Focus Panel
over1year
Wnt/β-Catenin-Pathway Alterations and Homologous Recombination Deficiency in Cholangiocarcinoma Cell Lines and Clinical Samples: Towards Specific Vulnerabilities. (PubMed, J Pers Med)
Ten of twelve cell lines harbored alterations in common HRR-related genes, and five cell lines were HRD-positive, although this parameter did not correlate well with Olaparib sensitivity. Moreover, functionally relevant APC and β-catenin mutations were registered, which were also detected in 4/176 (2.3%) samples on a CCA microarray. Although rare, these alterations were exclusive to large duct type CCA with associated intraductal papillary neoplasms of the bile duct (IPNB) in 3 cases, pointing at a distinct form of cholangiocarcinogenesis with potential specific vulnerabilities.
Preclinical • Journal • PARP Biomarker
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HRD (Homologous Recombination Deficiency) • FGFR (Fibroblast Growth Factor Receptor) • CTNNB1 (Catenin (cadherin-associated protein), beta 1)
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HRD • FGFR fusion
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AmoyDx® HRD Focus Panel
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Lynparza (olaparib)
over1year
Homologous recombination deficiency (HRD) in 543 ovarian cancer samples: A single center hands-on experience (ESMO 2022)
This option may address main concerns related to U.S. Food and Drug Administration (FDA) approved therapy with established companion diagnostics such as cost, test send-out and optimized performance. Our real-life experience underlines the technical challenges related to specimen quality and highlights the necessity for multidisciplinary education and collaboration throughout the patient care pathway.
Clinical • BRCA Biomarker • PARP Biomarker • BRCA Companion diagnostic • PARP Companion diagnostic
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
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HRD
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AmoyDx® HRD Focus Panel
almost2years
Analytical evaluation of a commercial in-house homologous recombination deficiency (HRD) assay for patients with epithelial ovarian cancers and its concordance with a reference standard. (ASCO 2022)
The HRD status assessed by AmoyDx HRD Focus Panel is highly concordant with that obtained using the current standard reference method. Commercial in-house test may offer a cost-effective, reliable and robust alternative to the centralized assay for the evaluation of HRD status in patient with EOC.
Clinical • PARP Biomarker • BRCA Biomarker
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
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BRCA2 mutation • BRCA1 mutation • HRD • HRD + BRCA1 mutation
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Myriad myChoice® CDx • AmoyDx® HRD Focus Panel
almost2years
The correlation of homologous recombination deficiency status with and Olaparib efficacy in Chinese ovarian cancer patients. (ASCO 2022)
HRD status tested by AmoyDx HRD Focus Panel is significantly correlated with the efficacy of Olaparib, and our results demonstrated a significant PFS benefit for HRD-positive patients compared with HRD-negative patients, especially for patients received Olaparib first-line maintenance therapy.
Clinical • PARP Biomarker • BRCA Biomarker
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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HRD • BRCA mutation
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AmoyDx® HRD Focus Panel
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Lynparza (olaparib)
over2years
An evaluation of the performance of molecular assays to identify homologous recombination deficiency-positive tumours in ovarian cancer (ESGO 2021)
Conclusion* F1CDx and AmoyDx HRD Focus Panel molecular HRD assays demonstrated concordance with, but not full equivalence to, myChoice CDx. Having multiple assays (providing their performance is adequate) to identify patients whose tumours harbour HRD is important to inform treatment decisions, as well as providing greater choice for clinicians and clinical laboratories.
Late-breaking abstract • PARP Biomarker • BRCA Biomarker • BRCA Complimentary diagnostic • PARP Complimentary diagnostic
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
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BRCA2 mutation • BRCA1 mutation • HRD • HRD + BRCA1 mutation • BRCA1 mutation + BRCA2 mutation
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FoundationOne® CDx • Myriad myChoice® CDx • AmoyDx® HRD Focus Panel