The study of the Merlin Assay is set to advance melanoma diagnostics. Credit: JPC-PROD / Shutterstock.

SkylineDx has completed patient enrolment for the landmark MERLIN_001 study of the Merlin Assay, which is set to advance melanoma diagnostics.

The study will prospectively validate the Merlin Assay, a clinicopathologic (CP) Gene Expression Profiling (GEP) test, in predicting the risk of sentinel node metastasis in melanoma patients.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

MERLIN_001 is claimed to be the largest independent multicentre prospective investigation into the GEP testing role in melanoma care till date.

The study aims to validate the Merlin Assay in a cohort of clinically node-negative primary cutaneous melanoma patients undergoing lymphatic mapping and sentinel lymph node biopsy (SLNB) according to current clinical guidelines.

The CP-GEP model, developed by Mayo Clinic and SkylineDx, will assess the metastatic potential in cutaneous melanoma patients.

This non-invasive prediction model could potentially allow certain patients at low risk for nodal metastasis to safely forgo the SLNB procedure.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The MERLIN_001 Study involved nine centres across the US and has enrolled 1,640 patients over the past three years.

This reflects a diverse cross-section of the melanoma population referred for SLNB, providing a comprehensive real-world perspective.

SkylineDx CEO Dharminder Chahal said: “The successful completion of patient enrolment in the MERLIN_001 study represents a monumental achievement in our melanoma research efforts.

“We are immensely grateful to all the patients who participated and to our dedicated team of researchers and collaborators.”

Previous prospective outcomes from the Netherlands have supported the performance metrics of the Merlin Assay, which has been shown to accurately identify patients at low nodal metastasis risk.

SkylineDx will analyse the data collected from the MERLIN_001 study and share the results with the medical community.

The insights gained are expected to enhance the precision and personalisation of melanoma care, with potential benefits for patients worldwide.