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First author: Weitemeyer
Journal / Conference: Nordic Melanoma Meeting

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.

First author: Sondak et. al
Journal / Conference: SMR 2024

Prospective multicenter evaluation (MERLIN_001 trial) of a clinicopathologic and gene expression profile test to predict sentinel node status in T1-T3 cN0 melanoma

Findings in a combined US and EU multi-center validation study show the potential ability of CP-GEP to support in risk stratifying patients with T1a melanoma.

Journal / Conference: SMR 2024

CP-GEP Identifies T1a Melanoma Patients At Risk of Sentinel Lymph Node Metastasis

Findings in a combined US and EU multi-center validation study show the potential ability of CP-GEP to support in risk stratifying patients with T1a melanoma.

Journal / Conference: EADV 2023

Personalized follow up in cutaneous squamous cell carcinoma: integrating a clinicopathological model for absolute metastasis risk into staging systems

By integrating an risk prediction model with established staging systems like AJCC/BWH, we’ve refined risk stratification in cutaneous squamous cell carcinoma. This empowers the identification of subgroups within lower stages, enhancing personalized follow-up schedules for improved patient outcomes.

First author: Hill
Journal / Conference: AAD conference 2024

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

Poster presented by Dr. Yu from University Hospital Cleveland Medical Center at AAD 2024. The abstract concludes that the CP-GEP assay improved risk stratification for nodal metastasis and disease recurrence in patients with cutaneous melanoma

Journal / Conference: AACR 2024

Avoiding the pitfalls in developing and validating prediction models for rare outcomes in nested case control

Delving into the intricacies of model development, insights are presented into optimizing predictive accuracy within nested case-control cohorts.

Journal / Conference: AACR 2024

Beyond staging systems in cutaneous squamous cell carcinoma: Validation of two thresholds for a model-estimated metastatic risk

In a significant advancement, we validate risk thresholds to discern high-risk subsets across diverse cutaneous squamous cell carcinoma stages, utilizing a robust independent nationwide UK cohort. This vital research aims to refine patient stratification and improve treatment outcomes.

Journal / Conference: AACR 2024

Efficient study design for the discovery of a gene expression signature predicting metastasis in cutaneous squamous cell carcinoma

Delve into the intricacies of designing a discovery cohort for studying rare disease outcomes. Explore unique challenges and unveil best practices for an efficient nested case-control approach.

Journal / Conference: ASH

ProMMis trial prospectively demostrates the efficacy of SKY92 risk stratification in newly diagnosed multiple myeloma patients

This study reinforces previous findings on SKY92’s prognostic value in multiple myeloma (MM). Integrating SKY92 with R-ISS enhances risk stratification, emphasizing its potential to guide personalized treatment strategies for MM patients.

Journal / Conference: ASH

Unveiling the discrepacy in multiple myeloma risk classification between clinical pratice and SKY92 test, and the impact on survival

Our findings validate SKY92’s efficacy in risk stratification for both progression-free survival (PFS) and overall survival (OS) in a prospective US multicenter trial. Integrating SKY92 enhances physicians’ confidence in treatment decisions by 40%.

Journal / Conference: ESMO 2023

Personalized follow up in cutaneous squamous cell carcinoma: integrating a clinicopathological model for absolute metastasis risk into staging systems

By integrating the risk prediction model with established staging systems (AJCC/BWH), we unveil valuable insights into cutaneous squamous cell carcinoma subgroups across all stages. This enhances risk stratification, promising improved clinical decision-making and patient outcomes.

Journal / Conference: eClinicalMedicine 2022

Development of a clinico-pathological model to estimate the absolute metastasis risk in patients with cutaneous squamous cell carcinoma

In this groundbreaking article, we unveil an absolute risk prediction model for cSCC patients, meticulously developed and rigorously validated. Leveraging routine clinical and pathological variables, it promises to revolutionize risk assessment and enhance patient care.

First author: Yu
Journal / Conference: SMR conference 2023

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

Multi-center US validation study unveils the potential of CP-GEP in predicting long-term survival outcomes

Journal / Conference: Journal of clinical oncology

Daratumumab, Cyclophosphamide, Bortezomib, Lenalidomide, and Dexamethasone as Induction and Extended Consolidation Improves Outcome in Ultra-High-Risk Multiple Myeloma

In the OPTIMUM (MUKnine) phase II trial, the UK consortium investigated Dara-CVRd induction followed by extended post-ASCT Dara-VRd consolidation in NDMM patients with high-risk chromosomal abnormalities and/or SKY92 high-risk status or plasma cell leukemia. This innovative approach markedly enhanced PFS compared to conventional methods.

Journal / Conference: Oral presentation ESPID

The diagnostic Kawasaki disease gene expression profiling (KiDs-GEP) classifier has a good performancein 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, particularly in challenging diagnostic scenarios.

First author: Weitemeyer
Journal / Conference: EADO

CP-GEP model to predict SN metastasis in melanoma: Validation on a Danish cohort

Independent European validation study confirming CP-GEP utility in Danish cohort. With key focus on thin melanoma achieving a SLNB reduction rate of >70% in T1’s.

First author: Pittelkow
Journal / Conference: SSO conference 2024

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 in the head and neck region. Our study elucidates its dual utility: predicting nodal metastases risk and long-term survival outcome.

First author: Thao
Journal / Conference: International Journal of Dermathology

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.

Journal / Conference: Oral presentation PReS

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, increasing precision and accuracy in clinical practice.

Journal / Conference: EADO 2022

Development of a clinico-pathological model to estimate the absolute metastasis risk in patients with cutaneous squamous cell carcinoma

In this poster, we unveil an absolute risk prediction model for cutaneous squamous cell carcinoma.

First author: Hieken
Journal / Conference: ASCO conference 2022

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.

Journal / Conference: Pediatric Research

Bridging a diagnostic Kawasaki disease classifier from a microarray platform to a qRT-PCR assay

This abstract 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. This adaptation achieves a more streamlined, cost-effective, and clinically viable approach, demonstrating advancement in diagnostic proficiency for hospital laboratories.

First author: Mulder
Journal / Conference: Cancers

Using a Clinicopathologic and Gene Expression (CP-GEP) Model to Identify Stage I–II Melanoma Patients at Risk of 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.

First author: Hieken
Journal / Conference: International Journal of Dermathology

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.

Journal / Conference: E-poster ESPID

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, demonstrating advancement in diagnostic proficiency for hospital laboratories.

First author: Tjien-Fooh
Journal / Conference: AAD Conference 2022

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.

Journal / Conference: frontiers in Oncology

Gene Expression Profiling in Multiple Myeloma: Redefining the Paradigm of Risk-Adapted Treatment

This comprehensive review addresses how high-risk multiple myeloma patients can be defined. Gene expression profiling emerges as a potent tool for precise risk stratification, guiding tailored treatment for strategies of multiple myeloma patients with confidence and efficacy.

First author: Johansson
Journal / Conference: European Journal of Surgical Oncology

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.

Journal / Conference: the journal of Molecular Diagnostic

Analytical Validation of SKY92 for the Identification of High-Risk Multiple Myeloma

We rigorously validated the SKY92 assay, establishing its credibility as a prognostic molecular test. Our meticulous approach ensures confidence in its precision and clarity.

Journal / Conference: International Journal of Laboratory Hematology

Prognostic gene expression analysis in a retrospective, multinational cohort of 155 multiple myeloma patients treated outside clinical trials

Our study reinforces the prognostic value of GEP markers outside clinical trials. By integrating them into conventional models, we enhance risk stratification in multiple myeloma, inspiring refined prognostic strategies.

First author: Mulder
Journal / Conference: British Journal of Dermatology.

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, demonstrating that the process of macrodissection can be omitted during sample preparation

Journal / Conference: eJHaem

Gene expression profiling impacts treatment decision making in newly diagnosed multiple myeloma patients in the prospective PROMMIS trial

ProMMis, a multicenter US study, assesses SKY92’s influence on risk classification and treatment strategies. SKY92 impacted treatment decisions in 37% of patients (p < 0.001). Physicians' final risk assessments aligned with SKY92 in 89% of cases. Furthermore, SKY92 significantly bolstered physicians' confidence in treatment decisions (p < 0.001). This study underscores SKY92's potential in enhancing treatment decision-making for multiple myeloma.

First author: Yousaf
Journal / Conference: International Journal of Dermatology.

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.

Journal / Conference: Blood advance

Prognostic and predictive performance of R-ISS with SKY92 in older patients with multiple myeloma: the HOVON-87/NMSG-18 trial

Our research unveils the pivotal role of SKY92 in refining prognostic accuracy of R-ISS, which was shown in multiple myeloma patients. The SKY92-R-ISS high-risk patients shows more beneficial effects from the HOVON-87/NMSG-18 trial with MPR-R with MPT-T, suggesting predictive value for treatment

Journal / Conference: Leukemia

Predicting ultrahigh risk multiple myeloma by molecular profiling: an analysis of newly diagnosed transplant eligible myeloma XI trial patients

Evaluating the synergistic predictive potential of combining high-risk chromosomal abnormalities and SKY92, our study unveils their predictive prowess in identifying ultra-high-risk multiple myeloma cases when a co-occurence of two or more chromosomal aberrations is found. This revelation fuels advancements in prognostic precision.

First author: Quattrocchi
Journal / Conference: International Journal of Dermathology

Primary cutaneous melanoma risk stratification using a clinicopathologic and gene expression model: 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

First author: Meves
Journal / Conference: Mayo Clin Proc Inn Qual Out.

Deselecting melanoma patients for sentinel lymph node biopsy during COVID-19: clinical utility of tumor molecular profiling.

The 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.

First author: Eggermont
Journal / Conference: Eur J Cancer

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.

First author: Bellomo
Journal / Conference: JCO PO

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

Journal / Conference: JAMA Pediatrics

Diagnosis of Kawasaki Disease Using a Minimal Whole-Blood Gene Expression Signature

Diagnosis of Kawasaki disease is based on clinical features and can be very challenging. This study demonstrates the identification of a 13-gene signature that is able to distinguish between Kawasaki disease and other febrile illnesses.

Journal / Conference: Lymphoma and Myeloma International Congress

Prognostic validation of SKY92 and its combination with ISS in an independent cohort of patients with Multiple Myeloma

In a rigorous examination, eight mRNA expression signatures were tested using an independent dataset of 91 multiple myeloma patients. SKY92 emerged as the most potent predictor of survival, showcasing its potential for precise risk stratification in multiple myeloma alongside the ISS.

Journal / Conference: Blood

Prediction of high- and low-risk multiple myeloma based on gene expression and the International Staging System

Through rigorous analysis spanning 4750 MM patients, our study evaluated the potency of integrating ISS, FISH markers, and gene classifiers to identify which is the best prediction model for risk classification of multiple myeloma patients. The ISS and EMC92 gene combination emerges as the strongest predictor for overall survival rate.

Journal / Conference: Leukemia

A gene expression signature for high-risk multiple myeloma

This publication unveils the identification of the EMC-92 gene signature, now known as SKY92, predicting the survival rate of newly diagnosed multiple myeloma patients. The signature is independently validated and independently prognostic of currently used prognostic factors.