Select the topic
Orginial Article | Validation
P-00158
Enhanced Risk Stratification for Sentinel Lymph Node Biopsy in Head and Neck Melanoma Using the Merlin Assay (CP‑GEP)
The Merlin Assay effectively categorizes head and neck melanoma patients by risk, enabling more accurate clinical decision-making regarding SLNB and follow-up evaluation, especially for early-stage melanoma patients.
2025
Orginial Article | Research
P-00173
Risk stratification using the Merlin Assay (CP-GEP) in an independent cohort of 930 patients with clinical stage I/II melanoma who did not undergo sentinel lymph node biopsy
This study shows that CP-GEP has the potential to stratify patients with early-stage melanoma who did not undergo SLNB based on their risk of recurrence. Patients with CP-GEP Low Risk have a significantly better long-term survival. CP-GEP shows to be promising for guiding SLNB referral and may support melanoma care by optimizing personalized treatment plans and potential surveillance regimens.
2025
Abstract | Validation
P-00163
Clinicopathologic and gene expression profile (CP-GEP) is a biomarker for outcome in patients with melanoma eligible for sentinel lymph node biopsy (SLNB)
The CP-GEP model demonstrated good prognostic performance in an independent validation cohort, particularly for pT1b-pT2a melanoma patients and thus should be considered added value to current standard of care practice.
Abstract | Validation
P-00171
Assessing risk of nodal metastasis and relapse-free survival by CP-GEP (Merlin™ Test) in a single-center retrospective case series of stage pT1a-4b cN0M0 melanoma patients
Merlin was validated in clinical practice in a single center using a retrospective cohort. The predictive value of the Merlin assay for sentinel node positivity was confirmed. In addition, it was shown that the Merlin assay allows relapse risk stratification.
Abstract | Validation
P-00164
Identification of patients at high risk for relapse using the Merlin Assay (CP-GEP) in an independent cohort of 930 patients (pts) with stage I/II melanoma who did not undergo sentinel lymph node biopsy
This comprehensive study shows that CP-GEP has the potential to stratify patients with early-stage melanoma who did not undergo SLNB based on their risk of recurrence. Patients with CP-GEP Low-Risk have a good long-term survival while patients with CP-GEP High-Risk have a high risk of recurrence. CP-GEP may have the potential to stratify patients beyond SLNB.
Abstract | Clinical Trial
P-00170
Prospective multicenter evaluation of a clinicopathologic and gene expression profile test to predict sentinel node status in T1-T3 cN0 melanoma: updated MERLIN_001 trial
First prospective multicenter blinded trial of CP-GEP (Merlin), a tool to predict sentinel node status (SLN) status, shows CP-GEP can reliably identify melanoma patients with <10% risk of SLN metastasis, suggesting its potential to more precisely estimate individual patient risk of SLN metastasis and inform decision-making for SLNB.
Abstract | Clinical Trial
P-00169
Prospective multicenter evaluation (MERLIN_001 trial, NCT04759781) of a clinicopathologic and gene expression profile test to predict sentinel node status in T1-T3 cN0 melanoma
First prospective multicenter blinded trial of CP-GEP (Merlin) shows CP-GEP test is able to reliably identify melanoma pts with >10% risk of SLN metastasis. For Stage IB pts SLN+ rate was 3-fold greater for High Risk vs Low Risk CP-GEP test.
Orginial Article | Prospective Trial
P-00172
Combining SKY92 gene expression profiling and FISH (according toR2‐ISS) defines ultra‐high‐risk Multiple Myeloma
Real word prospective study comparing SKY92 gene expression profiling and FISH HR markers accordingly with R2-ISS. The study highlights the prognostic value of SKY92 GEP in NDMM and RRMM patients in routine clinical practice. Combination of SKY92 and FISH HR marker can identify ultra-high-risk MM patients
2025
Poster | Validation
P-00141
Predictive Performance of the Clinicopathologic Gene Expression Profile (CP-GEP) in Identifying Cutaneous Melanoma Patients for Whom Sentinel Lymph Node Biopsy is Unnecessary: A Systematic Review and Meta-Analysis
This poster shows that the CP-GEP model demonstrates the hallmarks of an effective deselection tool for SLNB, particularly in patients with pT2 melanomas.
Poster | Prospective
P-00140
Using a clinicopathologic and gene expression profile (CP-GEP) model to predict prognosis in stage I-II melanoma
This poster shows that CP-GEP can stratify stage I-II melanoma patients into high- and low-risk for recurrence, suggesting its potential value in treatment decision-making and surveillance strategies for stage I-II melanoma.
Abstract | Clinical Trial
P-00137
Prospective multicenter evaluation (MERLIN_001 trial) of a clinicopathologic and gene expression profile test to predict sentinel node status in T1-T3 cN0 melanoma
First prospective multicenter blinded trial of CP-GEP model to predict sentinel lymph node status reliably identified melanoma patients with <10% risk of sentinel lymph node metastasis.
Poster | Validation
P-00138
CP-GEP identifies T1a melanoma patients at risk of sentinel lymph node metastasis
This multicenter retrospective validation study shows that CP-GEP (Merlin) is able to risk stratify T1a melanoma patients with and without adverse features into low and high risk for sentinel lymph node metastasis.
Poster | Clinical Implementation
P-00139
Impact of CP-GEP to improve selection of patients with melanoma who may forgo sentinel lymph node biopsy based on real world data
CP-GEP currently supports decision making in two melanoma centers in the Netherlands and its use has decreased SLNB rate in this cohort. A number of patients with pT1b melanoma was not included for CP-GEP. Their clinical risk for SN metastasis was either deemed low or there would not be any clinical consequences following SLNB. Based on these results, implementation of this test in the appropriate population) may significantly improve the selection of patients who can forgo SLNB, reducing the amount of unnecessary surgery and adding to more personalized treatments for patients with melanoma.
Poster | Verification
P-00049
The diagnostic Kawasaki disease gene expression profiling classifier has a good performance in difficult to diagnose Kawasaki disease subgroups
This abstract demonstrates the effectiveness of the KiDs-GEP classifier in accurately distinguishing Kawasaki disease patients from those with other febrile illnesses in an independent US cohort. Additionally, it shows that the classifier performs well in difficult to diagnose subgroups such as patients with incomplete Kawasaki disease and patients under 1 year of age. Finally, it shows that antibiotic use in Kawasaki disease patients does not impact the KiDs-GEP classifier score. These results indicate that the KiDs-GEP classifier can be used in difficult to diagnose Kawasaki disease subgroups and in Kawasaki disease patients treated with antibiotics.
Abstract | Clinical Implementation
P-00094
SKY92 Molecular Profiling in Combination with MRD by NGS to Identify High-Risk Multiple Myeloma Patients in Ireland (MM-PIRE)
Prospective clinical validation of SKY92 in real-word data from Irish transplant eligible newly diagnosed MM patients.
Poster | Validation
P-00042
Identification of patients at high risk for relapse using the Merlin Assay (CP-GEP) in an independent cohort of 432 patients with stage I/II melanoma who did not undergo sentinel lymph node biopsy
This study evaluated the performance of the Merlin Assay in primary cutaneous melanoma patients who did not undergo SLNB, identifying those patients who are at risk for relapse.
Abstract | Validation
P-00040
Identification of patients at high risk for relapse by Merlin Assay (CP-GEP) in an independent cohort of melanoma patients (pts) that did not undergo sentinel lymph node biopsy: a H&N subgroup analysis.
This study evaluated the performance of the Merlin Assay in primary cutaneous melanoma patients with tumors in the head and neck region who did not undergo SLNB, identifying those patients who are at risk for relapse.
Poster | Validation
P-00039
Using a clinicopathologic and gene expression profile (CP-GEP) model to predict prognosis in STAGE I-II melanoma: a multicenter Danish cohort study
An independent Danish validation study has confirmed the Merlin Assay's efficacy in predicting long-term survival outcome.
Poster | Validation
P-00037
Primary cutaneous melanoma patients stratified by the Merlin assay (CP-GEP): risk of nodal metastasis and long-term survival outcome in a U.S. cohort
This abstract concludes that CP-GEP improves risk stratification for nodal metastasis while also giving insights on long-term survival in primary cutaneous melanoma patients.
Poster | Validation
P-00038
Head & neck primary cutaneous melanoma patients stratified by CP-GEP (Merlin Assay): risk of nodal metastasis and long-term survival outcome
This research conducts a thorough assessment of the Merlin Assay's performance in primary cutaneous melanoma patients with tumors in the head and neck region. This study elucidates the dual utility of the assay: predicting nodal metastases risk and long-term survival outcome.
Orginial Article | Clinical Implementation & Prospective Validation
P-00034
Clinical evaluation of the clinicopathologic and gene expression profile (CP-GEP) in patients with melanoma eligible for sentinel lymph node biopsy: a multicenter prospective Dutch study
Prospective Dutch multicenter study for the application of the Merlin Assay as a diagnostic aid for patient triage in clinical settings, highlighting its potential role in streamlining patient care.
2023
Poster | Clinical Implementation
P-00127
Prommis Trial Prospectively Demonstrates the Efficacy of SKY92 Risk Stratification in Newly Diagnosed Multiple Myeloma Patients
Interim analysis of the PROMMIS study showed that SKY92 is a reliable prognostic marker for MM patients. In addition, its combination with R-ISS is able to identify a higher number of high-risk patients with significantly shorter PFS and OS compared to the conventional R-ISS alone.
Poster | Clinical Implementation
P-00128
Unveiling the Discrepancy in MultipleMyeloma Risk Classifi cation betweenClinical Practice and SKY92 Test and theImpact on Survival
Interim analysis of the PROMMIS study aims to evaluate risk classification of MM patients comparing conventional clinical risk markers with the SKY92 classifier.
Abstract | Clinical Implementation
P-00129
Ultra High-Risk Multiple Myeloma Patients with Multi-Hit Tumours and SKY92 High RiskSignature Are at Increased Risk of Early Relapse Even When Treated with Extended Intensifi edInduction and Consolidation – Results from the Optimum/Muknine Trial
Follow-up survival data of the OPTIMUM trial (Kaiser et al 2023)
Poster | Validation
P-00036
Long-term follow-up of melanoma patient risk stratified by a clinicopathologic and gene expression profile (CP-GEP) model: a multi-center United States cohort study
Multicenter US validation study unveils the potential of CP-GEP in predicting long-term survival outcomes
Abstract | Validation
P-00035
Using a clinicopathologic and gene expression model to predict sentinel lymph node metastasis in primary cutaneous melanoma could reduce the rate of sentinel lymph node biopsies with >70%: a multicentre Danish cohort study
An independent Danish validation study has confirmed the Merlin Assay's efficacy in predicting nodal metastases.
Publication | Validation
P-00033
Using a clinicopathologic and gene expression model to predict sentinel lymph node metastasis in primary cutaneous melanoma could reduce the rate of sentinel lymph node biopsies with >70%: a multicentre Danish cohort study
An independent Danish validation study has confirmed the Merlin Assay's efficacy in predicting nodal metastases.
Orginial Article | Clinical Implementation
P-00088
Daratumumab, Cyclophosphamide, Bortezomib, Lenalidomide, Dexamethasone as Induction and extended Consolidation Improves Outcome in Ultra-High Risk Multiple Myeloma
This study demonstrated that the treatment proposed in the OPTIMUM trial significantly improves progression-free survival (PFS) and overall survival (OS) in ultra-high-risk multiple myeloma (MM) and plasma cell leukemia (PCL) patients identified through molecular screening, which incorporates cytogenetic abnormalities and the SKY92 GEP.
2023
Abstract | Verification
P-00048
The diagnostic Kawasaki disease gene expression profiling (KiDs-GEP) classifier has a good performance in both complete and incomplete Kawasaki disease patients
This abstract demonstrates the effectiveness of the KiDs-GEP classifier in accurately distinguishing Kawasaki disease patients from those with other febrile illnesses within a US cohort. Additionally, it elucidates the consistent performance of the KiDs-GEP classifier across patients with complete and incomplete Kawasaki disease, offering valuable insights into its diagnostic utility.
Publication | Validation
P-00032
Using a clinicopathologic and gene expression model to predict sentinel lymph node metastasis in primary cutaneous melanoma could reduce the rate of sentinel lymph node biopsies with >70%: a multicentre Danish cohort study
An independent Danish validation study has confirmed the Merlin Assay's efficacy in predicting nodal metastases.
Abstract | Clinical Implementation
P-00093
Risk stratification combining SKY92 gene expression profiling and traditional FISH in multiple myeloma: the first prospective evidence in the R2-ISS era
Prospective clinical validation of SKY92 in real-word data from German newly diagnosed MM and relapse refractory MM patients.
Poster | Clinical Implementation
P-00126
Combining SKY92 gene expression profiling and IGH clonality to evaluate genetic risk in Irish multiple myeloma patients
Prospective clinical validation of SKY92 in real-word data from Irish transplant eligible newly diagnosed MM patients.
Poster | Clinical Trial
P-00030
MERLIN_001: A prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of SN-negative melanoma patients.
The MERLIN_001 trial has been initiated with the aim to prospectively validate the Merlin Assay's predictive accuracy for SLNB status and its prognostic significance in patients with melanoma who have tested negative for SLNB.
Abstract | Validation
P-00031
Using a clinicopathologic and gene expression model to predict sentinel lymph node metastasis in primary cutaneous melanoma could reduce the rate of sentinel lymph node biopsies with >70%: a multicentre Danish cohort study
An independent Danish validation study has confirmed the Merlin Assay's efficacy in predicting nodal metastases.
Orginial Article | Validation
P-00029
Identification of stage I/II melanoma patients at high risk for recurrence using a model combining clinicopathologic factors with gene expression profiling (CP-GEP)
In an independent European validation study, CP-GEP showed to be a reliable tool for predicting disease recurrence in stage I/II melanoma patients. Furthermore, for the first time the efficacy of CP-GEP is demonstrated in a patient group who did not receive sentinel lymph node biopsy (SLNB).
2023
Orginial Article | Health Economics
P-00027
Cost evaluation of the Merlin assay for predicting melanoma sentinel lymph node biopsy metastasis
By comparing Merlin testing to usual care, we demonstrate a path towards cost saving strategies by implementation of a novel decision-making tool in prescribing SLNB, reducing unnecessary surgeries and associated complications.
2023
Abstract | Clinical Implementation
P-00124
Extended Intensified Post-ASCT Consolidation with Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (Dara-VRd) for Ultra-High Risk (UHiR) Newly Diagnosed Myeloma (NDMM) and Primary Plasma Cell Leukemia (pPCL): The UK Optimum/Muknine Trial
Interim analysis of the OPTIMUM trial. The findings presented in this abstract were further developed and expanded in the publication by Kaiser et al. 2023.
Publication | Clinical Implementation
P-00028
Vroegtijdig herkennen van melanoompatienten met laag risico op SN-metastase: een implementatie studie
Prospective Dutch multicenter study for the application of the Merlin Assay as a diagnostic aid for patient triage in clinical settings, highlighting its potential role in streamlining patient care.
Poster | Clinical Implementation
P-00125
Advanced Risk Stratification in Multiple Myeloma Beyond Traditional FISH The First Prospective Real-World Evidence for SKY92 Gene Expression Profiling
Prospective clinical validation of SKY92 in real-word data from German newly diagnosed MM and relapse refractory MM patients.
Publication | Review
P-00026
Breslow thickness 2.0: Why gene expression profiling is a step toward better patient selection for sentinel lymph node biopsies
Review on how gene expression profiling may help in better select patients for sentinel lymph node biopsy.
2022
Abstract | Verification
P-00047
Distinguishing Kawasaki disease from other febrile conditions in a US cohort with the Kawasaki Disease Gene Expression Profiling (KiDs-GEP) classifier
The abstract highlights significant distinctions in KiDs-GEP classifier scores between Kawasaki disease and other febrile illnesses. This suggests its potential as a valuable diagnostic tool.
Orginial Article | Validation
P-00067
Prognostic gene expression analysis in a retrospective, multinational cohort of 155 multiple myeloma patients treated outside clinical trials
This study presents the first clinical validation of SKY92 classifier outside clinical trials.
2022
Orginial Article | Clinical Implementation
P-00018
Using the Merlin assay for reducing sentinel lymph node biopsy complications in melanoma: a retrospective cohort study
The Merlin Assay has the potential to significantly advance melanoma management by accurately identifying patients at low risk for nodal metastases, thus improving triage for surgery and limit the number of surgeries and associated complications.
2022
Orginial Article | Bridging
P-00046
Bridging a diagnostic Kawasaki disease classifier from a microarray platform to a qRT-PCR assay
This publication outlines the bridging of a gene signature from microarray technology to quantitative reverse transcription PCR (qRT-PCR), resulting in the development of the KiDs-GEP classifier.
2022
Orginial Article | Validation
P-00025
Using a clinicopathologic and gene expression (CP-GEP) model to identify stage I-II melanoma patients at risk for disease relapse
The first independent European validation study showcased the predictive power of CP-GEP in assessing disease recurrence risk in stage I/II melanoma patients, offering prospects for better prognostication in melanoma patients.
2022
Poster | Validation
P-00022
Prognostic significance of the CP-GEP assay combining clinicopathological factors and gene expression profiling in AJCC v8 stage I/II cutaneous melanoma (CM) patients (pts)
In an independent European validation study, CP-GEP showed to be a reliable tool for predicting disease recurrence in stage I/II melanoma patients. Furthermore, for the first time the efficacy of CP-GEP is demonstrated in a patient group who did not receive sentinel lymph node biopsy (SLNB).
Poster | Prospective
P-00023
Use of Merlin Assay to identify patients with a low-risk for SN metastasis in a prospective multicenter Dutch study of a primary melanoma gene-signature (CP-GEP model) to predict sentinel node status during COVID-19
Prospective Dutch multicenter study for the application of the Merlin Assay as a diagnostic aid for patient triage in clinical settings, highlighting its potential role in streamlining patient care.
Poster | Clinical Trial
P-00024
MERLIN_001: A prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of SN-negative melanoma patients
The MERLIN_001 trial has been initiated with the aim to prospectively validate the Merlin Assay's predictive accuracy for SLNB status and its prognostic significance in patients with melanoma who have tested negative for SLNB.
Poster | Bridging
P-00045
Bridging the diagnostic Kawasaki disease gene expression profiling classifier from microarray to a clinically applicable multiplex qRT-PCR assay (KiDs-GEP)
This abstract outlines the transition/ bridging of a gene signature from microarray technology to quantitative reverse transcription PCR (qRT-PCR), resulting in the development of the KiDs-GEP classifier. This adaptation achieves a more streamlined, cost-effective, and clinically viable approach, which could lead to advancement in diagnostic proficiency for hospital laboratories.
Poster | Clinical Implementation
P-00020
Using the Merlin assay for reducing sentinel lymph node biopsy complications in melanoma: a retrospective cohort study
The Merlin Assay has the potential to significantly advance melanoma management by accurately identifying patients at low risk for nodal metastases, thus improving triage for surgery and limit the number of surgeries and associated complications.
Abstract | Clinical Implementation & Prospective Validation
P-00021
Use of CP-GEP to identify primary cutaneous melanoma patients with a low risk for SN metastasis in a prospective multicenter Dutch study during COVID-19
Prospective Dutch multicenter study for the application of the Merlin Assay as a diagnostic aid for patient triage in clinical settings, highlighting its potential role in streamlining patient care.
Abstract | Validation
P-00019
Cutaneous melanoma patients with minimal SN tumor burden: CP-GEP (Merlin Assay) may guide decision-making beyond nodal assessment
This study evaluated the Merlin Assay's utility in melanoma patients with minimal sentinel node (SN) tumor burden. The study aims to determine the assay's potential to delineate more precise prognostic profiles, thereby facilitating tailored therapeutic strategies for this specific patient subset.
Orginial Article | Validation
P-00017
Validation of a clinicopathological and gene expression profile model to identify patients with cutaneous melanoma where sentinel lymph node biopsy is unnecessary
The European validation of the Merlin Assay showed a comparative analysis with established nomograms and includes a subgroup evaluation for melanoma patients aged 65 and above, increasing the understanding of its predictive performance in an elderly cohort.
2022
Orginial Article | Discovery
P-00087
Identification of High-Risk Multiple Myeloma With a Plasma Cell Leukemia-Like Transcriptomic Profile
This study describes the development of a transcriptomic classifier for PCL-like disease. This classifier identifies newly diagnosed multiple myeloma (NDMM) patients with a molecular profile similar to primary plasma cell leukemia (pPCL).
2022
Review | Overview risk classification MM
P-00066
Gene Expression Profiling in Multiple Myeloma: Redefining the Paradigm of Risk-Adapted Treatment
Review article about the use of GEP for risk stratification in multiple myeloma and how it can provide valuable insights for tailoring risk-adapted therapies to improve outcomes.
2022
Orginial Article | Validation
P-00016
Validation of CP-GEP (Merlin Assay) for predicting sentinel lymph node metastasis in primary cutaneous melanoma patients: A U.S. cohort study
An independent validation study in the United States has confirmed the Merlin Assay's efficacy, specifically assessing its performance in the management of melanoma among patients aged 65 and older.
2021
Orginial Article | Validation
P-00008
Validation of a clinicopathological and gene expression profile model for sentinel lymph node metastasis in primary cutaneous melanoma
This study serves as the first independent validation in Europe, showcasing the Merlin Assay's effectiveness and demonstrating that the process of macrodissection can be omitted during sample preparation.
2021
Abstract | Clinical Implementation
P-00079
Depth of response and minimal residual disease status in ultra high-risk multiple myeloma and plasma cell leukemia treated with daratumumab, bortezomib, lenalidomide, cyclophosphamide and dexamethasone (Dara-CVRd): Results of the UK optimum/MUKnine trial.
Interim analysis of the OPTIMUM trial. The findings presented in this abstract were further developed and expanded in the publication by Kaiser et al. 2023.
Orginial Article | Clinical Implementation
P-00086
Gene expression profiling impacts treatment decision making in newly diagnosed multiple myeloma patients in the prospective PROMMIS trial
The PROMMIS study demonstrated that incorporating the SKY92 molecular signature into risk classification for MM patients significantly impacted risk classification, treatment decisions and increased physician confidence.
2021
Poster | Validation
P-00013
Independent Validation study of CP-GEP model (Merlin Assay) to identify patients who can safely forgo sentinel lymph node biopsy
The European validation of the Merlin Assay showed a comparative analysis with established nomograms and includes a subgroup evaluation for melanoma patients aged 65 and above, increasing the understanding of its predictive performance in an elderly cohort.
Poster | Validation
P-00014
Using the clinicopathologic and gene expression (CP-GEP) model to predict sentinel node status in patients with primary melanoma: A prospective cohort study during the COVID-19 pandemic
Prospective study for the application of the Merlin Assay as a diagnostic aid for patient triage in clinical settings during the pandemic, highlighting its potential role in streamlining patient care.
Poster | Validation
P-00015
Using a clinicopathologic and gene expression (CP-GEP) model in Europe to identify stage II melanoma patients at high risk for disease relapse
The first independent European validation study showcased the predictive power of CP-GEP in assessing disease recurrence risk in stage II melanoma patients, offering prospects for better prognostication in melanoma patients.
Abstract | Discovery
P-00080
Predictive gene expression-based biomarkers for the treatment of multiple myeloma patients
Identification of novel predictive biomarkers to help identify best treatment for MM patients.
Abstract | Validation
P-00081
High-risk Multiple Myeloma patients are missed without gene expression profiling
This abstract shows that SKY92+ISS can help to identify true high-risk patients that may be missed by clinical risk markers.
Orginial Article | Protocol
P-00096
MUKnine OPTIMUM: Screening high-risk multiple myeloma patients for novel treatments and a phase II study on optimized biological therapy in newly diagnosed high-risk multiple myeloma and plasma cell leukemia.
MUKnine OPTIMUM clinical trial protocol
2021
Orginial Article | Analytical validation
P-00065
Analytical Validation of SKY92 for the Identification of High-Risk Multiple Myeloma
Analytical validation of SKY92. This study showed high concordance rates for sensitivity, specificity, and reproducibility across various testing conditions.
2021
Abstract | Development
P-00004
A combined clinicopathologic and gene expression model (CP-GEP) identifies primary cutaneous melanoma patients who can safely forgo sentinel lymph node biopsy
This study demonstrates the development of the CP-GEP model, also known as the Merlin Assay, designed to predict the outcomes of sentinel lymph node biopsies (SLNB) in individuals with primary cutaneous melanoma.
Letter | Feasibility
P-00003
Primary cutaneous melanoma risk stratification using a clinicopathologic and gene expression model: a pilot study
This study examines the practicality of implementing the Merlin Assay as an external laboratory test for standard patient management in the United States.
2020
Orginial Article | Discovery
P-00009
Identification of stage I/IIA melanoma patients at high risk for disease relapse using a clinicopathologic and gene expression model
This initial evaluation assesses CP-GEP's capacity to predict recurrence risks in patients with stage I/IIA melanoma, offering new insights into disease management.
2020
Orginial Article | Validation
P-00084
Prognostic and predictive performance of R-ISS with SKY92 in older patients with multiple myeloma: the HOVON-87/NMSG-18 trial
This study found that combining SKY92 with R-ISS creates a superior prognostic marker compared to using either marker alone. The SKY-RISS combination also serves as a predictor for response to immunomodulatory agents: benefit of MPR-R over MPT-T was observed specifically in high-risk patients.
2020
Abstract | Validation
P-00078
The Prognostic Power of Gene Expression Profiling with Cytogentics and Routinely Acquired Serum Markers: SKY92 Combined with Revised ISS
Validation of SKY92-RISS in the CoMMpass dataset.
Abstract | Validation
P-00123
High-Risk Multiple Myeloma Patients Are Missed without Gene Expression Profiling
This study demonstrated that many high-risk MM patients may be overlooked without the use of SKY92, as it can identify additional high-risk, rapidly progressing patients not detected by conventional risk markers.
Letter | Clinical Implementation
P-00011
Deselecting melanoma patients for sentinel lymph node biopsy during COVID-19: clinical utility of tumor molecular profiling
This case report details the application of the Merlin Assay as a diagnostic aid for patient triage in clinical settings during the pandemic, highlighting its potential role in streamlining patient care.
2020
Abstract | Clinical Implementation
P-00012
The use of a clinicopathologic and gene expression model (Merlin Assay) to risk stratify cutaneous melanoma patients in clinical practice: A pilot study
The study examines the practicality of implementing the Merlin Assay as an external laboratory test for standard patient management in the United States.
Poster | Validation
P-00010
Validation of a model combining clinicopathologic risk factors and a gene expression profile to identify primary melanoma patients who can safely forgo sentinel lymph node biopsy
An independent validation study in the United States has confirmed the Merlin Assay's efficacy, specifically assessing its performance in the management of melanoma among patients aged 65 and older.
Abstract | Development
P-00007
Identification of stage IIA melanoma patients at high risk for disease relapse using a clinicopathologic and gene expression model
This exercise investigated the possibility to design a stage-specific operating point for the CP-GEP model to select stage IIA patients at high risk for disease relapse.
Poster | Validation
P-00006
Using a clinicopathologic and gene expression model to identify melanoma patients at high risk for disease relapse
This initial evaluation assesses CP-GEP's capacity to predict recurrence risks in patients with stage I/IIA melanoma, offering new insights into disease management.
Orginial Article | Development
P-00005
Model Combining Tumor Molecular and Clinicopathologic Risk Factors Predicts Sentinel Lymph Node Metastasis in Primary Cutaneous Melanoma
This study demonstrates the development of the CP-GEP model, also known as the Merlin Assay, designed to predict the outcomes of sentinel lymph node biopsies (SLNB) in individuals with primary cutaneous melanoma.
2020
Orginial Article | Clinical Implementation
P-00085
Predicting ultrahigh risk multiple myeloma by molecular profiling: an analysis of newly diagnosed transplant eligible myeloma XI trial patients
The study validated the SKY92 GEP as a predictor of significantly shorter progression-free survival (PFS) and overall survival (OS) in multiple myeloma patients. The presence of two or more high-risk chromosomal markers, along with the SKY92 high-risk signature, effectively identifies patients with a poor prognosis, regardless of their treatment regimen. These findings suggest that high-risk patients may benefit from more intensive treatment strategies.
2020
Poster | Clinical Implementation
P-00117
Prognostic Molecular Stratification in Relapsed/Refractory Multiple Myeloma - Results of the Pomalidomide Mukseven (NCT02406222) Biomarker Trial
This abstract presents the validation of SKY92 classifier in a cohort of relapse refractory MM patients (MUKseven)
Poster | Clinical Implementation
P-00120
Molecular Treatment Stratification for Newly Diagnosed High-Risk Myeloma, Including Plasma Cell Leukemia - FeasibilityResults of the Ukmra Optimum: MUK9 Trial (NCT03188172)
Interim analysis of the OPTIMUM trial. The findings presented in this abstract were further developed and expanded in the publication by Kaiser et al. 2023.
Poster | Validation
P-00002
Validation of a Clinicopathological and Gene Expression Profile (CP-GEP) Model for Sentinel Lymph Node Metastasis in Primary Cutaneous Melanoma
The first independent European validation study showcased the predictive power of CP-GEP in assessing disease recurrence risk in stage I/II melanoma patients, offering prospects for better prognostication in melanoma patients.
Poster | Validation
P-00116
Validation of SKY92 high and low risk prognostication in a retrospective, multinational cohort of 155 non-trial multiple myeloma patients
Interim analysis of the study that was published by Chen et al. 2022.
Abstract | Validation
P-00122
Prognostic and predictive performance of SKY92 combined with R-ISS in elderly multiple myeloma patients in the HOVON-87 NMSG-18 study
This study shows that the SKY92-ISS and R-ISS are robust markers to identify hig- risk patients, also in non-transplant eligible MM patients. Both markers have independent prognostic value in relation to overall and progression free survival. In addition, the SKY92-R-ISS combination demonstrates predictive value for treatment in this trial.
Poster | Development
P-00001
A molecular model to identify patients who can safely forgo sentinel lymph node biopsy in primary cutaneous melanoma
This study demonstrates the development of the CP-GEP model, also known as the Merlin Assay, designed to predict the outcomes of sentinel lymph node biopsies (SLNB) in individuals with primary cutaneous melanoma.
Publication | Health Economics
P-00134
Cost-effectiveness of risk-stratified treatment in transplant-eligible patients with Multiple Myeloma
This study evaluated a risk-stratified treatment approach for transplant-eligible MM patients. It was found that treatment of low-risk patients with the VMP regimen resulted in better survival and quality-adjusted life years compared to HDM+ASCT.
Poster | Clinical Implementation
P-00119
Comparison of RISS and IMWG risk stratification guidelines with gene expression profile SKY92 PROMMIS
Interim analysis of the PROMMIS trial. The findings presented in this abstract were further developed and expanded in the publication by Biran et al 2021.
Publication | Health Economics
P-00148
Does Quality Of Life In Multiple Myeloma Patients Differ Between Nationalities A European Multinational Study
This study showed that the quality of life (QoL) for multiple myeloma (MM) patients varies significantly between different nationalities within Europe.
Orginial Article | Validation
P-00064
CyBorD-DARA is potent initial induction for MM and enhances ADCP: initial results of the 16-BCNI-001/CTRIAL-IE 16-02 study
Application of SKY92 classifier in patients enrolled in a phase Ib trial assessing the safety and preliminary efficacy of Daratumumab on initial induction therapy.
2019
Poster | Clinical Implementation
P-00118
Prospective study to measure the impact of MMprofiler on treatment intention in newly diagnosed multiple myeloma patients (PROMMIS)
Interim analysis of the PROMMIS trial. The findings presented in this abstract were further developed and expanded in the publication by Biran et al 2021.
Poster | Validation
P-00121
Prognosis in elderly Multiple Myeloma patients in the HOVON-87 NMSG-18 study based on revised ISS and SKY92-ISS
This study shows that the SKY92 classifier effectively identifies high-risk individuals in non-transplant eligible MM patients. In addition, it shows that SKY92 provides prognostic value independent of the R-ISS, and that high-risk patients benefit from lenalidomide treatment over thalidomide treatment.
Abstract | Validation
P-00077
Cybord-Dara Is a Highly Effective Upfront Treatment for Newly Diagnosed Multiple Myeloma. Initial Efficacy Results of the 16-Bcni-001/Ctrial-IE (ICORG) 16-02 Study
This abstract presents the validation of the SKY92 gene expression classifier combined with ISS in the 16-Bcni-001/Ctrial-IE (ICORG) 16-02 Study
Abstract | Clinical Implementation
P-00095
Preliminary Analysis of the ALLG MM17 Trial: Response-Adaptive Salvage Treatment with KTd for Newly Diagnosed Transplant-Eligible Multiple Myeloma Patients Failing Front-Line Bortezomib-Based Therapy
This abstract presents the validation of SKY92 in the ALLG MM17 trial.
Poster | Validation
P-00113
Differential Effect of Upfront Intensification Treatment in Genetically Defined Myeloma Risk Groups – a Combined Analysis of ISS, Del17p and SKY92 Scores in the EMN-02/HOVON-95 MM Trial
Molecular and clinical subclassification, using SKY92, ISS and chromosomal aberration, in MM may identify patients that benefit from alternative treatment strategies.
Poster | RNA-seq bridging and validation
P-00114
RNA-seq based risk stratification in Multiple Myeloma patients validates SKY92 as a high risk marker in the CoMMpass trial
This study showed that SKY92 classifier can effectively be converted from a microarray to an RNA-Seq platform.
Orginial Article | Health Economics
P-00063
Potential therapeutic and economic value of risk-stratified treatment as initial treatment of multiple myeloma in Europe
This study found that using risk-stratified treatment (RST), where high-risk multiple myeloma patients get more intensive and expensive treatments while standard-risk patients receive less costly options, is both more effective and cheaper than giving all patients the same treatment. The RST strategy using the SKY92 biomarker showed the greatest health benefits, suggesting that adopting this approach could improve patient outcomes and reduce costs.
2018
Abstract | Discovery
P-00147
Predicting treatment benefit in Multiple Myeloma through simulation of alternative treatment effects
In this study, it was developed an algorithm to predict treatment response in MM patients. The findings presented in this abstract were further developed and expanded in the publication by Ubels et al 2018
Abstract | Discovery
P-00074
The Level of Circulating Myeloma Cells at Diagnosis Correlates with a Plasma Cell Leukemia-like Phenotype of the Corresponding Myeloma Cells in Bone Marrow
This study describes the identification of a distinct gene expression profile in bone marrow samples from multiple myeloma patients with high circulating tumor cells loads, suggesting that these tumors exhibit advanced disease characteristics and may represent a transitional phase between multiple myeloma and plasma cell leukemia.
Abstract | Validation
P-00075
MMprofiler with SKY92 Combined with ISS Identifies High and Low Risk Multiple Myeloma in the VTD Arm of Gimema-MMY-3006
This abstract presents the validation of the SKY92 gene expression classifier combined with ISS in the Gimema-MMY-3006 trial
Poster | Health Economics
P-00111
Potential therapeutic and economic value of risk-stratified treatment as initial treatment of multiple myeloma in Europe
This study indicates that risk-stratified treatment (RST) in MM could enhance health outcomes and reduce costs compared to uniform treatment, with an RST strategy utilizing molecular markers like SKY92. The final findings of this study were published in Gaultney at al. 2018.
Publication | Validation
P-00062
Hoog- en laagrisico-multipel myeloom kunnen worden voorspeld met de combinatie van EMC92 en ISS
Article in Dutch. This study compared and combined the conventional MM risk markers, such as ISS, FISH markers, and GEP classifiers, to create a novel risk classification for MM. The EMC92/SKY92-ISS classification was found to be the strongest predictor of overall survival, providing a robust four-group risk model.
2017
Orginial Article | Validation
P-00083
Prognostic Validation of SKY92 and Its Combination With ISS in an Independent Cohort of Patients With Multiple Myeloma
An independent dataset of MM patients was tested with eight prognostic gene expression signatures. The SKY92 signature was found to be the best predictor of survival, classifying the largest fraction of patients as high risk.
2017
Poster | Validation
P-00112
Gene expression classifier EMC92 SKY92 and revised ISS robustly identify high-risk Multiple Myeloma in elderly patients of the HOVON-87 NMSG-18 study
This study presents the validation of the SKY92 gene expression classifier and R-ISS in elderly, non-transplant eligible patients included in the HOVON-87/NMSG-18 trial.
Poster | Discovery
P-00146
TOPSPIN: a novel algorithm to predict treatment specific survival in cancer
In this study, it was developed an algorithm to predict treatment response in MM patients. The findings presented in this abstract were further developed and expanded in the publication by Ubel et al 2018.
2017
Abstract | Clinical Implementation
P-00092
Integrating molecular genetic and gene expression profiling allows stratification of ultra-high risk myeloma
Integrating genetic and SKY92 gene expression risk profiling facilitate identification of ultra-high risk patient and could help the development of innovative treatment approaches in myeloma. The findings of this study were further developed and expanded in the publication Shah et al 2021
Orginial Article | Validation
P-00061
Gene signature combinations improve prognostic stratification of multiple myeloma patients
This study investigated the integration of multiple GEP signatures to improve risk stratification in MM. The combination of EMC92 and HZDCD proved to be the most effective prognostic tool, providing a possible approach for using GEP signatures to enhance patient risk assessment in clinical practice.
2016
Abstract | Validation
P-00072
Comprehensive Biologic Characterization of 99 Multiple Myeloma Patients Using Cytomorphology, FISH, Gene Expression Profiling and Mutation Screening Leads to Important Clinical and Therapeutic Insights
Comprehensive analysis of MM based on cytogenetic, gene expression and mutation data to improve understanding of the disease biology and classification.
Abstract | Validation
P-00073
Phase 2 Study of Carfilzomib, Thalidomide, and Low-Dose Dexamethasone As Induction/Consolidation in Newly Diagnosed, Transplant Eligible Patients with Multiple Myeloma, the CarthadexTrial
This abstract presents the validation SKY92 classifier in patients enrolled in phase 2 Carthadex trail
Abstract | Clinical Implementation
P-00091
Identifying Ultra-High Risk Myeloma by Integrated Molecular Genetic and Gene Expression Profiling
Application of SKY92 in patients enrolled in NCRI Myeloma XI trial. The findings presented in this abstract were further developed and expanded in the publication by Shah et al 2020.
Poster | Analytical validation
P-00130
Precision as part of the analytical validation of the SKY92 high-risk signature and the MMprofiler assay
Analytical validation of SKY92 test. The findings presented in this abstract were further developed and expanded in the publication by van Been et al 2021.
Poster | Validation
P-00132
Robustness of the prognostic value of the SKY92 marker versus FISH markers across nine Multiple Myeloma cohorts
SKY92, both alone and in combination with ISS, has proven to be a robust prognostic marker for multiple myeloma across nine different patient cohorts. In contrast, the evaluated FISH markers did not demonstrate consistent prognostic value.
Poster | Validation
P-00133
The SKY92 prognostic marker is validated in eight Multiple Myeloma clinical datasets
This study validated the prognostic value for PFS and OS of the SKY92 high risk marker in newly diagnosed and relapsed refractory Multiple Myeloma across a wide variety of clinical trial datasets.
Abstract | Validation
P-00089
A Phase II Study of Modified Lenalidomide, Bortezomib, and Dexamethasone (RVD-lite) for Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma
This abstract presents the validation of SKY92 in newly diagnosed MM patients treated with modified RVD ("RVD-lite") induction.
Abstract | Validation
P-00090
Low-Risk Multiple Myeloma By SKY92+ISS Validated in the Multiple Myeloma Genomics Initiative Study
This study compared the prognostic value GEP versus coventional clinical risk markers, as FISH and ISS. The findings presented in this abstract were further developed and expanded in the publication by Kuiper et al. 2015.
Poster | Validation
P-00109
Validation of the EMC92/SKY92 Signature in HOVON-87/Nmsg-18: Gene Expression Based Prognostication Is Applicable in Elderly Patients with Newly Diagnosed Multiple Myeloma
This study shows that SKY92 is a useful prognostic marker to identify a high-risk MM patients in the elderly population.
Poster | Validation
P-00110
The Combination of SKY92 and ISS Provides a Powerful Tool to Identify Both High Risk and Low Risk Multiple Myeloma Cases, Validation in Two Independent Cohorts
This abstract presents the validation of SKY92 in two independent datasets (TT6 and a dataset of patients enrolled at two hospitals in the Czech Republic and in Slovakia)
Orginial Article | Validation
P-00060
Prediction of high- and low-risk multiple myeloma based on gene expression and the International Staging System
This study compared and combined the conventional MM risk markers, such as ISS, FISH markers, and GEP classifiers, to create a novel risk classification for MM. The EMC92/SKY92-ISS classification was found to be the strongest predictor of overall survival, providing a robust four-group risk model. ISS demonstrated clear independent additive prognostic value when combined with GEP classifiers or FISH markers.
2015
Abstract | Overview risk classification MM
P-00069
Risk assessment and stratification
This abstract presents an overview of specific genomic markers in MM.
Abstract | Validation
P-00070
The Risk Classification based on Gene Expression Profiling a Tool for Prediction of High- and Low-risk Multiple Myeloma across International Trials
This study compared the prognostic value GEP versus coventional clinical risk markers, as FISH and ISS. The findings presented in this abstract were further developed and expanded in the publication by Kuiper et al. 2015.
Poster | Validation
P-00108
SKY92 GEP, iFISH and ISS comparison for risk stratification in multiple myeloma
This study showed that SKY92 is a more effective prognostic marker than iFISH or FISH+ISS, with a hazard ratio that is twice as high. Additionally, combining ISS with SKY92 is straightforward and effectively identifies patients with a favorable prognosis.
Poster | Validation
P-00105
Prognostic and Predictive ve Gene Expression Profiling (GEP) Markers Confirmed in Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Treated Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts)
This study shows that the combination of SKY92 high-risk and virtual gain(1q) identifies a significant group of high-risk patients with inferior progression free survival in newly diagnosed MM patients treated with carfilzomib, lenalidomide, and dexamethasone (KRd) with or without ASCT.
Poster | Development/validation
P-00106
Single Sample Application of the EMC92 SKY92 Signature Using the MMprofiler
This abstract shows that the SKY92 score is nearly equivalent when derived from the data following single sample normalization and batch normalization, indicating that SKY92 can be used for single sample analysis.
Poster | Validation
P-00104
Prediction of High and Low-Risk Multiple Myeloma Based on the EMC92 Gene Expression Signature and the International Staging System
This study compared the prognostic value GEP versus coventional clinical risk markers, as FISH and ISS. The findings presented in this abstract were further developed and expanded in the publication by Kuiper et al. 2015.
Abstract | Validation
P-00107
Proteasome inhibitor treatment response can be predicted by gene expression profiling in Multiple Myeloma
This study found that certain genetic markers, including SKY92, were associated with longer OS when treated with PAD compared to VAD, suggesting these markers could be effective predictors for proteasome inhibition therapy.
Poster | Validation
P-00099
Predictors Of Treatment Outcome With The Combination Of Carfilzomib, Lenalidomide, and Low-Dose Dexamethasone (CRd) In Newly Diagnosed Multiple Myeloma (NDMM)
This abstract presents the validation of SKY92 in newly diagnosed MM patients enrolled in a Phase 1/2 trial (NCT01029054) treated with the combination of carfilzomib, lenalidomide, and low-dose dexamethasone (CRd).
Poster | Validation
P-00100
Comparison Of Conventional, FISH and GEP Prognostic Factors In Multiple Myeloma: Introducing a Novel Risk Stratification
This study compared the prognostic value GEP versus coventional clinical risk markers, as FISH and ISS. The findings presented in this abstract were further developed and expanded in the publication by Kuiper et al. 2015.
Poster | Validation
P-00101
High Risk Multiple Myeloma Cases Are Identified In An MMRC Led Study By The SKY92 Gene Signature (MMprofiler)
This abstract presents the validation of SKY92 in MM patients using data from a publicly available GEP dataset.
Poster | Development
P-00102
An assay for simultaneous diagnosis of diagnosis of t(4;14), t(11;14),t(14;16)/t(14;20), DEL1P, ADD1Q, DEL13Q, DEL17P, MS/MF expression clusters, and the SKY92 high risk signature in multiple myeloma patients
In this study it was developed a standardized assay for simultaneous detection of different chromosomal aberrations (including t(4;14), t(11;14), t(14;16)/t(14;20), del1p, add1q, del13q, and del17p) and SKY92 in MM patients.
Abstract | Validation
P-00103
Combining FISH and GEP signatures in multiple myeloma towards a more robus and meaningful high risk definition
This study compared the prognostic value GEP versus coventional clinical risk markers, as FISH and ISS. The findings presented in this abstract were further developed and expanded in the publication by Kuiper et al. 2015.
Orginial Article | Discovery
P-00059
A gene expression signature for high-risk multiple myeloma
In this study, a prognostic signature based on gene expression profiles of myeloma cells (EMC-92/SKY92) was developed. This signature accurately predicts survival in newly diagnosed multiple myeloma patients (NDMM), demonstrating its effectiveness across multiple validation sets and showing that it is independent of existing prognostic factors.
2012
Abstract | Discovery
P-00098
A high-risk survival signature for multiple myeloma
This abstract describes the discovery of the SKY92 signature. The findings presented in this abstract were further developed and expanded in the publication by Kuiper et al. 2012.
Poster | Discovery
P-00097
A High-Risk Survival Classifier for Multiple Myeloma
This abstract describes the discovery of the SKY92 signature. The findings presented in this abstract were further developed and expanded in the publication by Kuiper et al. 2012.
Abstract | Discovery
P-00068
Prognostic Impact of Genetic Subgroups and Development of Gene Classifiers for Response, PFS and OS In Multiple Myeloma Patients Treated with Bortezomib or Conventional Agents In HOVON65/GMMG-HD4 Trial
This abstract describes the discovery of the SKY92 signature. The findings presented in this abstract were further developed and expanded in the publication by Kuiper et al. 2012.
