COMPANY:

Skyline Dx

"SkylineDx...today announced that results from its landmark MERLIN_001 trial, the largest prospective evaluation of a genomic test in cutaneous melanoma, have been published in the October 2025 issue of JAMA Surgery, the most cited surgery journal in the world. The study demonstrates that the Merlin CP-GEP Test stratified T1-T3 melanomas with clearly distinct risk levels for sentinel node metastasis: patients with a High-Risk result had a three-fold higher rate of sentinel node metastasis compared to those with a Low-Risk result (23.8% vs. 7.1%) overall."

"SkylineDx...will launch its new European patient access program, Merlin for Me®, at the ADO Congress 2025. During an industry symposium, SkylineDx will also present how Merlin Assay’s gene expression (CP-GEP) analyses can precisely assess the risk of primary melanoma recurrence, based on recent scientific studies."

"SkylineDx...today announced detailed results from a Danish validation study, published in the Journal of Surgical Oncology. The study demonstrates that SkylineDx’s Merlin Assay (CP-GEP) can identify cutaneous melanoma patients, in particular pT1 and pT2 patients, that have a low risk for nodal metastasis and therefore may forgo Sentinel lymph node biopsy (SLNB) surgery. Merlin is a genomic test to guide treatment decisions in early-stage melanoma."

"SkylineDx...announced today an independent meta-analysis in Critical Reviews of Oncology/Hematology. The study demonstrates that SkylineDx’s Merlin CP-GEP Assay accurately stratifies patients with cutaneous melanoma for optimal selection for sentinel lymph node biopsy (SLNB), an invasive surgical procedure with the potential for complications. Merlin is a genomic test to guide treatment decisions in early-stage melanoma"

"SkylineDx...announces the publication of new results from the PRospective Observational Multiple Myeloma Impact Study (PROMMIS) in the British Journal of Haematology [1]. The paper prospectively validates SKY92’s prognostic performance using real-world data and assesses its impact on risk classification and (hypothetical) treatment decisions compared to conventional markers. This prospective, real-world study reinforces the clinical utility of the SKY92 gene expression profiling (GEP) classifier in improving risk stratification and guiding treatment decisions in multiple myeloma (MM) patient care."

"SkylineDx...presenteda new independent study at the American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating that its Merlin Assay (CP-GEP), a genomic test to guide treatment decisions in early-stage melanoma, can reliably identify patients with head and neck (H&N) melanoma at high risk for recurrence—even in the absence of sentinel lymph node biopsy (SLNB)"

"SkylineDx...will present groundbreaking new data at the 2025 World Congress of Melanoma (WCM). The presentation will highlight the Merlin CP-GEP (Clinicopathologic and Gene Expression Profile) test’s ability to identify high-risk melanoma patients who did not undergo sentinel lymph node biopsy (SLNB), a critical gap in current melanoma staging methods – showing CP-GEP’s potential in predicting relapse and other long-term survival outcomes [1-2]."

"SkylineDx...announce that groundbreaking data on the Prognostic Value of the SKY92 Classifier over High-Risk Cytogenetic Aberrations in Multiple Myeloma will be presented during the upcoming American Society of Hematology (ASH) conference...the significant impact of SKY92 on risk stratification in multiple myeloma patients...Patients that had the high-risk biomarker SKY92 had significantly worse progression-free survival rates, regardless of whether they had other genetic abnormalities."

"The results showed that individual chromosomal abnormalities and their co-occurrence had limited prognostic value, with the sole exception of the 1q21 abnormality, which prognostic significance for PFS was exclusive to patients aged 65 years and older. SKY92 proved to be a much stronger predictor of poor outcomes. Patients that had the high-risk biomarker SKY92 had significantly worse progression-free survival rates, regardless of whether they had other genetic abnormalities....The research also showed that combining SKY92 results with specific genetic markers like gain(1q21) could offer even more detailed insights. For example, patients flagged as high-risk by both tests had some of the poorest outcomes, underlining the complementary value of using SKY92."

"SkylineDx...announced today the results of a comprehensive systematic review and meta-analysis conducted by Melanoma Institute of Australia (MIA). This independent study validates the predictive power of SkylineDx's Clinicopathologic Gene Expression Profile (CP-GEP) model, known as the Merlin test, in guiding the decision-making process for Sentinel Lymph Node Biopsy (SLNB) in patients with cutaneous melanoma."

"SkylineDx...announces that late-breaking data evaluating its Merlin test will be presented as part of the Plenary Session and a poster presentation at the upcoming Society for Melanoma Research (SMR) being held from October 10-13, 2024, in New Orleans, LA."

"SkylineDx...proudly announces the successful enrollment of the MERLIN_001 study. This study is the largest independent multicenter prospective investigation to date into the role of Gene Expression Profiling (GEP) testing in melanoma care. This milestone marks the conclusion of enrollment with the final patient now included in this groundbreaking prospective registry study."