Rotterdam – September 12, 2026 -- SkylineDx has completed its transition from third-party distribution to a fully integrated U.S. commercial organization for Merlin CP-GEP, scaling its dedicated sales, marketing and clinical staff from three representatives in early 2025 to more than 25 professionals across key U.S. territories.
SkylineDx ends third-party U.S. distribution deals for melanoma test
The Rotterdam- and San Diego-based diagnostics company has concluded all third-party commercialization and licensing collaborations that previously handled U.S. market access for Merlin CP-GEP. The newly built direct organization now supports healthcare professionals, institutions and patients nationwide, with most new hires working directly with clinicians in the field.
MERLIN_001 trial, NCCN listing and FDA designation back commercial push
The expansion follows the publication of the prospective, blinded MERLIN_001 trial, conducted with U.S. academic institutions, which validated Merlin CP-GEP's ability to assess sentinel lymph node metastasis risk in melanoma patients. The test subsequently gained recognition in the NCCN Clinical Practice Guidelines in Oncology (Version 3.2026) for informing sentinel lymph node biopsy decisions in T1b and T2a cutaneous melanoma patients. In 2026, Merlin CP-GEP also received FDA Breakthrough Device Designation, making it the first and only melanoma gene expression profiling test to hold both that status and NCCN Guidelines recognition.
"We have moved from three sales representatives in early 2025 to a multidisciplinary U.S. organization of more than 25 people, with most of that investment in professionals working directly with clinicians in key territories," said Dharminder Chahal, CEO of SkylineDx.
Company plans further investment in evidence and melanoma center partnerships
SkylineDx said it intends to deepen U.S. investment as adoption of Merlin CP-GEP grows, directing additional resources toward clinical evidence generation, medical education and collaborations with leading melanoma centers. Merlin CP-GEP is marketed in the U.S. as a laboratory-developed test and is sold in the EU, EEA and UK as the CE-IVD and UKCA marked Merlin Assay.