SkylineDX’s test for evaluating metastatic risk in early-stage cutaneous melanoma patients has obtained breakthrough device designation from the US Food and Drug Administration (FDA).
The Dutch biotech’s Merlin clinicopathologic gene expression profile (CP-GEP) test functions as a predictive model and was developed alongside Mayo Clinic. By combining CP-GEP variables into a single integrated algorithm, the test stratifies cutaneous melanoma patients into high- or low-risk groups for metastases. This capability puts patients in a better position to receive appropriate surgical action, the company stated.
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Merlin is already available in the US and Europe as a laboratory developed test (LDT). The breakthrough designation will speed up the review process for commercialisation.
SkylineDX highlighted that the FDA breakthrough designation builds on the LDT’s existing recognition by the National Comprehensive Cancer Network’s Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a predictive GEP test to support metastatic risk assessment and clinical decision-making in T1b and T2a melanoma patients.
SkylineDX CEO, Dharminder Chahal, commented: “Breakthrough device designation underscores the potential of Merlin CP-GEP to advance personalised melanoma care and support more informed, patient-centred treatment decisions.
“Patients deserve access to the best available tools supported by rigorous clinical evidence and recognised in clinical practice guidelines.”
Current regulatory state of the LDT space
LDTs have been in a regulatory whirlwind in recent years. In April 2025, the FDA’s Final Rule that sought to regulate LDTs as medical devices was struck down in a Texas court. The FDA chose not to challenge the ruling and scrapped these regulatory plans in September 2025.
However, a bill introduced by Congressman Neal Dunn in May 2026 suggests that an update to the way LDTs are regulated could still happen in the future.
Entitled the ‘Enhancing Clinical Laboratory Innovation and Access Act (Enhancing CLIA Act)’ of 2026, Dunn’s bill outlined a means to update the regulation of diagnostic testing services under the Clinical Laboratory Improvement Amendments (CLIA) to ‘further innovation’.
Upon the bill’s introduction, Congressman Dunn said: “This legislation restores confidence in testing services while avoiding duplicative and burdensome requirements that limit patient access and slow scientific progress. We can ensure necessary oversight of the CLIA programme without undermining the laboratories that deliver cutting-edge diagnostics to patients across the country.”
Unlike the FDA’s Final Rule, which many in the diagnostics industry fiercely opposed, Dunn’s proposed bill has been received positively by many of the industry’s most significant entities.
Following the bill’s release, Susan Van Meter, president of the American Clinical Laboratory Association (ACLA), said: “ACLA appreciates Representative Neal Dunn, M.D.’s thoughtful approach to updating the Clinical Laboratory Improvement Amendments (CLIA) programme to ensure that the regulatory framework for clinical laboratories keeps pace with innovations in clinical laboratory science and medicine, enhances oversight of LDT services without compromising innovation, and increases transparency in LDTs for providers and patients.
“CLIA has long provided a strong foundation for laboratory oversight, and the legislation recognises the important role that LDTs serve in delivering timely, personalised, and actionable health information for patients and providers.”
