Independent European data on CP-GEP model in Stratifying Melanoma Patients for Long Term Survival

ROTTERDAM, Netherlands and SAN DIEGO, April 5, 2024 /PRNewswire/ -- SkylineDx is pleased to announce two forthcoming scientific publications at the European Association for Dermato-Oncology congress, April 4-6, 2024. These publications show Merlin test's (CP-GEP model) ability to identify early-stage cutaneous melanoma patients at high risk for relapse.

The first is a study led by researchers from Denmark, Weitemeyer, et al, that examined over 400 patients who underwent a sentinel lymph node biopsy (SLNB) between 2010 and 2015¹. All the biopsies were defined as negative for metastasis. The CP-GEP model was applied on the prospectively collected, archived tumor specimens and its outcome correlated with the patients' clinical data for 5 years following diagnosis (for both recurrence free survival and overall survival). The findings indicate that the model effectively stratifies node-negative patients in two groups: patients at low – and high risk for disease progression. In the high-risk group, 17.2% experienced a recurrence of the disease in the 5-year following diagnosis compared to 8% in the low-risk group.

While a nodal assessment by means of the SLNB surgery remains the gold standard for clinical staging of cutaneous melanoma, not all eligible patients might undergo this invasive procedure. Node biopsies in the head and neck location may be challenging due to the regional course of nerves and lymphatic drainage². The second study, led by Dr. Amaral from University of Tuebingen, Germany, assessed the performance of the CP-GEP model in a group of patients that did not undergo the SLNB procedure. More specifically, she focusses on a subgroup of melanoma patients with a primary tumor in the head and neck region. CP-GEP showed to be able to identify patients with a high risk for recurrence in this independent dataset. The authors concluded that the model demonstrates potential to risk stratify patients with early-stage melanoma³.

"Both studies provide promising insights into CP-GEP's capacity to stratify patients based on their risk for disease progression and its potential value to support treatment and surveillance strategies for early melanomas." says Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx .

About CP-GEP
CP-GEP is a non-invasive prediction model for cutaneous melanoma patients that combines clinicopathologic (CP) variables with gene expression profiling (GEP). This model is able to identify cutaneous melanoma patients at low-risk for nodal metastasis who may forgo the sentinel lymph node biopsy (SLNB) procedure. The CP-GEP model was developed by Mayo Clinic and SkylineDx BV and it has been clinically validated in multiple studies More information (including references) may be obtained at www.falconprogram.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase the access. In the United States, Tempus is commercializing Tempus Merlin test.

Quest Diagnostics launched their own LDT version of the CP-GEP model in the United States under the brand name MelaNodal Predict™.

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. M. B.-M. Weitemeyer et al. Using a clinicopathologic and gene expression model to predict prognosis in stage I-II primary cutaneous melanoma: a multicenter Danish cohort study. Weitemeyer EADO 2024.pdf (falconprogram.com)
2. Hieken et al. Head & neck primary cutaneous melanoma patients stratified by CP-GEP (Merlin Assay): risk of nodal metastasis and long-term survival outcome. SSO 2024. Abstracts SSO2024 Hieken.pdf (falconprogram.com).
3. Amaral et al. 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. EADO 2024. Amaral EADO 2024.pdf (falconprogram.com)

SOURCE SkylineDx