COMPANY:

Skyline Dx

"SkylineDx today announced the publication of new data by Dr. Wesley Yu, et al ²., demonstrating that Merlin CP-GEP identifies a clinically meaningful High-Risk subset of T1a melanoma patients with a risk of sentinel lymph node (SLN) positivity above established NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) thresholds. CP-GEP (Merlin CP-GEP) is a gene expression profile test recognized by the NCCN Guidelines® as predictive of SLN positivity risk, supported by validation in the largest, prospective, blinded, gene expression profile study in melanoma"

"SkylineDx today announced that the National Comprehensive Cancer Network® (NCCN®) has updated its Clinical Practice Guidelines in Oncology for Cutaneous Melanoma (Version 1.2026), recognizing Merlin CP-GEP¹ (clinicopathologic–gene expression profile test) as the first and only molecular test that may be used in select early-stage melanoma patients."

"SkylineDx...announced today an independent analysis in Annals of Surgical Oncology validating that its Merlin CP-GEP Test accurately identifies the risk of sentinel node metastases and recurrence in patients with clinical stage I and II melanoma."

"SkylineDx today announced the release of new data from two complementary, peer-reviewed publications that reinforce the clinical value of the Merlin CP-GEP Test for melanoma risk stratification. Together, these studies demonstrate that prospectively validated genomic tools are essential to improve clinical decision-making and reduce both under- and overtreatment in early-stage melanoma."

"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."