SkylineDx Completes Transition to Direct U.S. Commercial Model for Merlin CP-GEP

SkylineDx, an innovative diagnostics company based in Rotterdam and San Diego, has completed a significant transition in its U.S. commercial strategy for its molecular diagnostic test, Merlin CP-GEP. The company has shifted from a third-party commercialization model to a fully integrated direct commercial organization, establishing a dedicated sales, marketing, and clinical team of more than 25 professionals across key U.S. markets.

This strategic move, driven by the company’s belief that direct engagement with clinicians is essential for the successful adoption of Merlin CP-GEP, marks a substantial milestone in SkylineDx's commitment to supporting the U.S. melanoma community. The new commercial model, which began with a small team of three sales representatives in early 2025, now encompasses a multidisciplinary organization focused on providing comprehensive support to healthcare professionals, institutions, and patients.

The expansion of SkylineDx’s direct commercial presence comes alongside notable clinical and regulatory achievements for Merlin CP-GEP. The test, which combines clinicopathologic factors with gene expression profiling to provide additional information on melanoma patient risk, has seen validation through the MERLIN_001 trial. Conducted in collaboration with leading U.S. academic institutions, the trial provided prospective, blinded validation of Merlin CP-GEP in patients with melanoma. Following the publication of these results, CP-GEP (Merlin CP-GEP) received recognition in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for melanoma, further cementing its role in guiding sentinel lymph node biopsy decision-making in appropriately selected patients.

In 2026, Merlin CP-GEP was also granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), marking another important milestone in the company’s efforts to advance more individualized melanoma care. These achievements have underscored the company’s decision to invest directly in the U.S. market and build the necessary infrastructure to support broader clinical adoption.

"Our strategy is straightforward: if we want clinicians to have the highest level of service, scientific support, and access to Merlin CP-GEP, we need to be directly invested in the market," stated Dharminder Chahal, CEO of SkylineDx. "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. This is not simply a commercial expansion, it represents our long-term commitment to the U.S. melanoma community."

SkylineDx’s commitment to advancing evidence-based precision medicine and providing clinicians with the scientific, clinical, and operational support needed to integrate molecular diagnostics into patient care is reflected in its comprehensive approach. The company aims to deepen its commitment as Merlin CP-GEP adoption grows, while also investing in additional clinical evidence, medical education, and collaborations with leading melanoma centers.

With the completion of the transition to a direct commercial model, SkylineDx is well-positioned to accelerate access to Merlin CP-GEP and support clinicians in making informed decisions regarding sentinel lymph node biopsy. The company’s focus on direct engagement with the U.S. melanoma community highlights its dedication to improving patient outcomes through innovative diagnostics.