SkylineDx's Merlin Test Secures Dual FDA & NCCN Nod for Melanoma Care

ROTTERDAM, Netherlands – July 01, 2026 – In a move set to reshape the landscape of early-stage skin cancer management, diagnostics innovator SkylineDx announced today that its Merlin CP-GEP test for cutaneous melanoma has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This designation makes Merlin the first and only melanoma gene expression profiling (GEP) test to hold both the coveted FDA Breakthrough status and a recommendation within the influential National Comprehensive Cancer Network (NCCN) guidelines for its specific patient population.

The dual validation marks a pivotal moment for personalized medicine in oncology. For the thousands of patients diagnosed annually with early-stage (T1b/T2a) cutaneous melanoma, the news signals a potential shift away from one-size-fits-all diagnostic pathways toward a more precise, data-driven approach that could spare many from invasive surgical procedures.

Transforming the Clinical Dilemma

For dermatologists and oncologists, managing early-stage melanoma often involves a difficult decision: whether to perform a sentinel lymph node biopsy (SLNB). This surgical procedure checks if the cancer has spread to nearby lymph nodes, but it carries risks of complications and is negative in the vast majority of early-stage cases. The challenge has been accurately identifying which patients truly need it.

This is the critical unmet need that SkylineDx’s Merlin test is designed to address. By integrating a patient’s unique clinicopathologic (CP) data with the expression patterns of specific genes (GEP) from the primary tumor, the test generates a simple, binary risk assessment: High Risk or Low Risk for metastasis.

"This tool allows us to move beyond population-level statistics and have a more individualized conversation about risk," explained a leading oncologist at a major U.S. cancer center who is familiar with the technology. "For a patient identified as ‘Merlin Low Risk,’ we can discuss forgoing an SLNB with much greater confidence. Conversely, a ‘High Risk’ result on a patient who otherwise looks low-risk on paper ensures they get the attention they need."

The clinical evidence backing this is robust. The designation was supported by the MERLIN_001 study, the largest prospective trial of its kind, published in JAMA Surgery. The study found that patients flagged as High-Risk by the Merlin test had a more than three-fold likelihood of their cancer having spread to the sentinel nodes compared to those in the Low-Risk group. The test successfully stratified nearly 40% of patients into the Low-Risk category, for whom an invasive biopsy may be unnecessary.

The Power of a Breakthrough Designation

Receiving FDA Breakthrough Device Designation is more than a regulatory feather in a company's cap; it's an accelerator for innovation. The program is reserved for novel technologies that provide for more effective diagnosis or treatment of life-threatening diseases. For SkylineDx, it means a prioritized review pipeline and a more collaborative, interactive relationship with the FDA to expedite market access.

Crucially, this status has downstream commercial and clinical implications. It positions the Merlin test favorably for reimbursement considerations, including the new RAPID coverage pathway from the Centers for Medicare & Medicaid Services (CMS). This pathway, established in April 2026, is designed to slash the time between FDA market authorization and national Medicare coverage, ensuring that groundbreaking technologies reach patients faster.

This accelerated pathway is a game-changer for medical device companies, removing a significant hurdle that has historically delayed the adoption of important new diagnostics. It signals a clear intent from regulatory and reimbursement bodies to support innovations that deliver tangible clinical value.

A Strategic Triumph in Molecular Diagnostics

This dual recognition represents a significant strategic victory for SkylineDx, a biotechnology firm with headquarters in the Netherlands and a key operational and laboratory presence in San Diego. The company, which collaborated with the prestigious Mayo Clinic to develop the advanced CP-GEP model, has successfully navigated the arduous journey from academic research to a commercially viable, clinically validated, and guideline-recommended product.

By securing inclusion in the NCCN guidelines—the gold standard for clinical practice in oncology—the company ensured that clinicians would have the confidence to integrate the test into their decision-making processes. The subsequent FDA Breakthrough Designation adds a layer of regulatory validation and a powerful commercial tailwind. This one-two punch effectively distinguishes the Merlin test in a competitive diagnostics market.

"Patients deserve access to the best available tools supported by rigorous clinical evidence and recognized in clinical practice guidelines," stated Dharminder Chahal, CEO of SkylineDx, in the company's announcement. The statement underscores the firm's strategy: building an unassailable case for clinical utility through high-quality prospective data, and then leveraging that evidence to clear regulatory and guideline hurdles.

The result is a powerful feedback loop. Guideline inclusion drives clinical adoption, which generates more real-world data and strengthens the case for reimbursement. FDA Breakthrough status accelerates the path to broader market access, further fueling this cycle. For a company focused on bridging the gap between gene-signature discovery and clinical utility, the Merlin story serves as a powerful validation of its core mission and business model.