SkylineDx Expands Direct U.S. Commercial and Clinical Investment to Accelerate Access to Merlin™ CP-GEP

• SkylineDx completes transition from third-party commercialization to a fully integrated U.S. commercial model, establishing a dedicated sales, marketing and clinical organization of more than 25 professionals strategically positioned across key U.S. markets
• The continuing expansion builds on landmark clinical and regulatory milestones for Merlin CP-GEP, including publication of the prospective, blinded MERLIN_001 trial, recognition in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), and FDA Breakthrough Device Designation

ROTTERDAM, Netherlands and SAN DIEGO, Sept. 9, 2026 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research, development and commercialization of molecular diagnostics for dermatology and oncology, today announced the continued expansion of its direct commercial and clinical presence in the United States, marking a significant milestone in the company's commitment to supporting clinicians and expanding patient access to Merlin CP-GEP¹.

When SkylineDx initially began commercializing Merlin CP-GEP in the United States, the company utilized third-party distribution and licensing collaborations to establish market access and introduce the test to U.S. clinicians. In early 2025, SkylineDx made the strategic decision to transition to a direct commercial model and invest in its own U.S.-based sales, marketing and clinical organization.

That initial build-out is now complete; SkylineDx has concluded its third-party U.S. commercialization collaborations and has now established a fully integrated direct commercial organization responsible for supporting healthcare professionals, institutions, and patients across the country. With this foundation in place, SkylineDx continues to expand its commercial capabilities and geographic reach to support the growing adoption of Merlin CP-GEP.

The expansion reflects SkylineDx's belief that bringing an innovative molecular diagnostic into clinical practice requires more than making a test commercially available. It requires direct engagement with clinicians, responsive clinical and operational support, education around the scientific evidence, and a long-term commitment to the institutions and healthcare professionals incorporating the technology into patient care.

"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," said 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."

The company's commercial expansion coincides with important clinical, guidelines, and regulatory milestones for Merlin CP-GEP.

The MERLIN_001 trial², conducted in collaboration with leading U.S. academic institutions, 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 ³, further supporting its role in informing sentinel lymph node biopsy decision-making in appropriately selected patients.

In 2026, Merlin CP-GEP also received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), representing another important milestone in SkylineDx's efforts to advance more individualized melanoma care.

Together, these achievements have reinforced the company's decision to invest directly in the U.S. market and build the infrastructure necessary to support broader clinical adoption. SkylineDx intends to deepen this commitment as Merlin CP-GEP adoption grows, while also investing in additional clinical evidence, medical education, and collaborations with leading melanoma centers.

"Our clinical progress and our commercial investment go hand in hand," added Chahal. "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 molecular test developed to provide additional information regarding a melanoma patient's risk of sentinel lymph node metastasis. By combining clinicopathologic factors with gene expression profiling, Merlin CP-GEP is designed to support more individualized clinical decision-making regarding sentinel lymph node biopsy. Merlin CP-GEP is now the first and only melanoma gene expression profiling test that is both designated as an FDA Breakthrough Device and recognized in the NCCN Guidelines® for T1b and T2a cutaneous melanoma patients.

More information may be obtained at www.merlinmelanomatest.com.

About SkylineDx

SkylineDx is a molecular diagnostics company focused on developing and commercializing innovative molecular diagnostic solutions that enable more personalized clinical decision-making. Through its growing direct U.S. commercial and clinical organization, SkylineDx is committed to advancing evidence-based precision medicine and providing clinicians with the scientific, clinical and operational support needed to integrate molecular diagnostics into patient care.

To learn more about SkylineDx, please visit www.skylinedx.com .

Footnotes

⁽¹⁾ Merlin CP-GEP is marketed in the USA as an LDT. In the EU EEA and UK, it is marketed under the name Merlin Assay, a CE-IVD and UKCA marked device.
⁽²⁾ Gene Expression Profile–Based Test to Predict Melanoma Sentinel Node Status: The MERLIN_001 Study | Dermatology | JAMA Surgery | JAMA Network
⁽³⁾ National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Cutaneous Melanoma (Version 3.2026) Link

Media Contact:

ICR Healthcare
Ally Stubin
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SkylineDx Contact
Linda Forlani
[email protected]

SOURCE SkylineDx