Real World Prospective Study shows clinical implementation of Merlin Assay (CP-GEP) in melanoma care

ROTTERDAM, Netherlands and SAN DIEGO, Oct. 31, 2023 /PRNewswire/ -- SkylineDx an innovative diagnostics company focused on research & development of molecular diagnostics for oncology and inflammatory diseases, proudly announces the successful clinical validation and implementation of the clinicopathologic and gene expression profile (CP-GEP) model in a multicenter Dutch study focused on patients with melanoma.

The study, titled "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," [1] aimed to evaluate the clinical use and implementation of the CP-GEP model in a prospective multicenter study in the Netherlands.

Melanoma, a highly aggressive form of skin cancer, often necessitates sentinel lymph node biopsy (SLNB) for staging, prognostication, and determining eligibility for adjuvant therapy. However, the majority of SLNB procedures do not reveal nodal metastasis, exposing patients to unnecessary surgeries and potential complications.

The CP-GEP model, known as the Merlin Assay™, was developed to identify patients at low risk for sentinel node metastasis, thereby helping determine whether they can forgo SLNB. This groundbreaking study aimed to evaluate the clinical utility and feasibility of implementing the CP-GEP model in a prospective multicenter setting in the Netherlands.

The CP-GEP model demonstrated an overall negative predictive value (NPV) of 96.7% and a positive predictive value (PPV) of 23.7% and showed a potential SLNB reduction rate of 42.2% in patients with T1-T3 melanoma.

Dr Jvalini Dwarkasing: "This study commenced at a challenging time in healthcare when resources were scarce and triage options needed to be considered. It was an innovative and collaborative effort to improve care. We are very pleased to see that the data from this prospective real world study confirms what we have seen on the performance in our retrospective studies." 

The study results validate the model's utility, making it a valuable tool in the management of melanoma patients

About the Merlin test

The Merlin test uses the CP-GEP model, a powerful proprietary algorithm that calculates the risk of metastasis in a patient's sentinel lymph nodes [3]. The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient's primary tumor, the tumor thickness, and the patient's age; and has been analytically and clinically validated. The main focus of the Merlin Study Initiative, developed under the wings of Falcon R&D Program, is to conduct further clinical research and validation studies on the predictive use of the CP-GEP model. More information (including references) may be obtained at www.falconprogram.com. The Merlin test is commercially available and reimbursed by Medicare as a Laboratory Developed Test serviced from SkylineDx's CAP/CLIA laboratory in San Diego (CA).

About SkylineDx

SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA. To learn more about SkylineDx, please visit www.skylinedx.com.

Footnotes

1. Stassen et al. 2023 EJSO. 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. https://www.ejso.com/article/S0748-7983(23)00887-9/fulltext