SkylineDx Expects New NCCN Guidelines on Melanoma Gene Expression to Drive Physician Adoption

The Dutch company's Merlin CP-GEP test for metastatic risk assessment in melanoma patients is primed for US physician uptake and payor reimbursement after guidelines inclusion.

Mar. 13, 2026 at 2:06pm

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Dutch firm SkylineDx is eyeing increased US uptake of its Merlin CP-GEP test for metastatic risk assessment in melanoma patients following a recent update to National Comprehensive Cancer Network's guidelines that suggest using the test in certain cases. SkylineDx obtained a CE-IVD certificate for the test in Europe in 2022 and markets it as the Merlin Assay there. The company is now focusing its commercial efforts on the NCCN guidelines, which it believes will have a significant impact on the demand increase for Merlin.

Why it matters

The updated NCCN guidelines suggest that SkylineDx's Merlin CP-GEP test could be used to stratify patients with stage T1 and T2 melanoma and to help determine treatment. This inclusion in the guidelines is expected to drive increased physician adoption and payor reimbursement of the test in the US.

The details

Merlin CP-GEP combines quantitative PCR-based gene expression profiling (GEP) of eight genes with clinicopathologic (CP) data to provide an informed assessment of sentinel lymph node (SLN) metastatic risk in patients with early-stage cutaneous melanoma. Backed with such data, clinicians can assign patients to the appropriate surgery action categories stipulated in the guidelines, determining who is likely to require a sentinel lymph node biopsy (SLNB) and who can forgo it.

  • SkylineDx obtained a CE-IVD certificate for the Merlin Assay in Europe in 2022.
  • NCCN recently updated its guidelines concerning cutaneous melanoma, suggesting that SkylineDx's Merlin CP-GEP test could be used to stratify patients with stage T1 and T2 melanoma.

The players

SkylineDx

A Dutch firm that maintains a CLIA-compliant lab in San Diego, from which it offers the Merlin CP-GEP test as a laboratory-developed test. SkylineDx obtained a CE-IVD certificate for the test in Europe in 2022 and markets it as the Merlin Assay there.

National Comprehensive Cancer Network (NCCN)

An alliance of 33 cancer centers that continuously updates clinical practice guidelines for different cancers. NCCN recently updated its guidelines concerning cutaneous melanoma, suggesting that SkylineDx's Merlin CP-GEP test could be used to stratify patients with stage T1 and T2 melanoma.

Alexander Meves

A researcher at the Mayo Clinic in Rochester, Minnesota, who collaborated with SkylineDx to develop the Merlin CP-GEP test based on his research on predicting the risk of metastasis and the need for sentinel lymph node biopsy.

Dharminder Chahal

The CEO of SkylineDx, who stated that the company's commercial efforts will "focus heavily on the NCCN guidelines" going forward, as they position Merlin CP-GEP as "the only GEP test that is permitted for use by the guidelines, which US physicians follow very diligently."

Castle Biosciences

A Friendswood, Texas-based company that has an established market presence with its DecisionDx-Melanoma test for assessing metastatic risk in melanoma patients.

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What they’re saying

“We have shown up with a product that we believe is quality, and has been validated.”

— Alexander Meves, Researcher, Mayo Clinic

“Our experience in the field of oncology product reimbursement demonstrates that products that are included in NCCN guidelines and have Medicare reimbursement are typically also reimbursed by commercial insurance payors.”

— Dharminder Chahal, CEO, SkylineDx

What’s next

SkylineDx is reaching out to all commercial payors asking for them to add Merlin CP-GEP to their reimbursement policies and reimburse the test for all non-Medicare patients.

The takeaway

The inclusion of SkylineDx's Merlin CP-GEP test in the updated NCCN guidelines for cutaneous melanoma is expected to drive increased physician adoption and payor reimbursement of the test in the US, as it positions the test as the only gene expression profiling test recommended by the guidelines that US physicians follow closely.