SkylineDX’s predictive melanoma test secures FDA breakthrough designation

SkylineDX’s test, which has now gained an FDA designation, stratifies cutaneous melanoma patients into metastatic risk categories to inform treatment decisions. SkylineDX’s test stratifies cutaneous melanoma patients into metastatic risk categories to inform treatment decisions. SkylineDX’s Merlin test stratifies early-stage cutaneous melanoma patients into risk groups to guide treatment decision-making. Credit: Tada Images/Shutterstock.com SkylineDX’s test for evaluating metastatic risk in early-stage cutaneous melanoma patients has obtained breakthrough device designation from the US Food and Drug Administration (FDA). The Dutch biotech’s Merlin clinicopathologic gene expression profile (CP-GEP) test functions as a predictive model and was developed alongside Mayo Clinic. By combining…

Source: Medical Device Network