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SkylineDx's New Era in U.S. Market

In a bold move aimed at revolutionizing melanoma care, SkylineDx has successfully transitioned from using third-party commercialization strategies to establishing a fully integrated U.S. commercial model for its innovative Merlin™ CP-GEP test. This shift marks a significant advancement in the company's mission to enhance patient access and support for healthcare professionals dealing with this serious condition.

Expansion of Commercial and Clinical Presence

SkylineDx, known for its focus on molecular diagnostics in dermatology and oncology, has successfully set up a comprehensive sales, marketing, and clinical operation consisting of over 25 professionals strategically located in key U.S. markets. This initiative not only expands their reach but also underscores their commitment to the melanoma community, as Dharminder Chahal, CEO of SkylineDx, firmly stated, "Our strategy is straightforward; if we want clinicians to have the highest level of service, we need to be directly invested in the market."

Before this transition, the company sought market access through third-party distributors and partnerships. However, in early 2025, SkylineDx recognized the need to take direct control of its U.S. operations and thus shifted to a model where it handles its sales, marketing, and clinical outreach directly.

Importance of Direct Engagement

SkylineDx’s philosophy towards commercialization highlights that bringing a groundbreaking molecular diagnostic tool to clinical practice involves more than just making it available; it necessitates engaging directly with clinicians to provide detailed support and educational resources. This engagement ensures that healthcare providers can effectively integrate the Merlin CP-GEP into their patient care frameworks.

The recent commercial expansion correlates with pivotal clinical milestones that signify the test's potential impact on melanoma treatment. The completion of the MERLIN_001 trial, a collaborative effort with notable U.S. academic institutions, validated the efficacy of Merlin CP-GEP, showcasing its reliability as a predictive tool for sentinel lymph node status in melanoma patients.

Additionally, the test's recognition in the NCCN Clinical Practice Guidelines for oncology further solidifies its role in assisting with sentinel lymph node biopsy decisions based on precise patient profiles. Furthermore, the receipt of FDA Breakthrough Device Designation in 2026 marks a critical recognition of the test's innovative nature, positioning it as a leader in personalized melanoma care.

Future Commitments

SkylineDx is enhancing its infrastructure to foster broader clinical adoption of Merlin CP-GEP. This involves a substantial commitment to ongoing clinical research, educational initiatives, and partnerships with leading melanoma treatment centers. Their dedicated U.S. team is poised to support these efforts, ensuring that clinicians have the resources and knowledge necessary to utilize the test effectively for their patients.

Chahal emphasized the importance of integrating clinical progress with commercial investments, stating, "The prospective MERLIN_001 evidence, NCCN Guidelines recognition, and FDA Breakthrough Device Designation provide a strong foundation. Our responsibility now is to ensure clinicians across the United States have the access, education, and direct support necessary to translate that evidence into patient care."

About Merlin CP-GEP

Merlin CP-GEP is a groundbreaking molecular test designed to deliver tailored insights into a melanoma patient’s risk of sentinel lymph node metastasis. By analyzing genetic expression alongside clinical factors, it aids in making more personalized choices in clinical practice regarding sentinel lymph node biopsies—and it holds the distinction of being the first melanoma gene expression profiling test recognized as an FDA Breakthrough Device and by national guidelines.

As SkylineDx forges ahead into this new chapter, it not only reinforces its dedication to melanoma care but also exemplifies how innovative companies can directly influence patient outcomes through strategic investments in their operations and community engagement.