Launch US prospective melanoma trial to validate Merlin Assay
ROTTERDAM (the Netherlands), SAN DIEGO (US), June 10, 2021: Today, SkylineDx announced that the first hospitals will start including melanoma patients in a large prospective clinical study in the United States, to validate the Merlin Assay. A total of 10 hospitals are collaborating in this trial, including Moffitt Cancer Center, Mayo Clinic and University of Louisville School of Medicine led by the respective principal investigators . In the coming two years, over 2,000 patients with invasive malignant melanoma (skin cancer) indicated for a sentinel lymph node surgery, will be enrolled and followed during 5 years .
The study’s primary objective is to determine the Merlin Assay’s performance on identifying patients that can safely forgo the invasive sentinel lymph node surgery under general anesthesia. This procedure is crucial to determine if the patient has metastasis, however in >80% of patients no metastasis are found making the surgery unnecessary . First results are anticipated within two years after the first patient has been included. The long-term objective, 3 to 5 years after inclusion, allows to follow the patient over time to monitor if the melanoma recurs . The design of this prospective trial was previously communicated during the melanoma tumor board symposium for registered attendees at the World Congress of Melanoma in March of this year .
“Merlin Assay will change patient lives. I am thrilled that so many renowned institutes believe in the strength of this test and want to participate in this trial”, comments Dharminder Chahal, CEO SkylineDx. “The 80-85% of patients that go through this surgery unnecessarily, do have a >10% risk of surgery-related complications like bleeding, infection and lymphedema where arms and legs swell because the lymph vessels are unable to adequately drain the lymph fluids. Each patient that Merlin can deselect for this invasive surgery, is a win”.
About Merlin Assay
The Merlin Assay uses the CP-GEP model, a powerful algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes . The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age; and has been independently validated in both a US  and EU  retrospective cohort. Further clinical research and validation studies on the predictive use of the CP-GEP model is the main focus of the Merlin Study Initiative, developed under the wings of the Falcon R&D Program. More information on www.falconprogram.com.
SkylineDx is a biotechnology company, focused on research & development of molecular diagnostics in oncology and inflammatory diseases. The company is headquartered in Rotterdam (the Netherlands) and complemented with a field medical and scientific affairs team in the US and a CAP/CLIA certified laboratory in San Diego (California). SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predict a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. To learn more, please visit www.skylinedx.com.
Link to this press release on website SkylineDx (click here).
MElanoma Research Lymph Node Prediction Implementation National_001 (MERLIN_001). ClinicalTrials.gov Identifier: NCT04759781 (Link to NCT04759781).
Refining the Role of Sentinel Lymph Node (SLNB) in Melanoma, satellite symposium at WCM 2021. (link to on demand video).
Bellomo et al., 2020. Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precision Oncology 4:319-334 (link to Bellomo paper).
Yousaf et al., 2021. Validation of CP-GEP (Merlin Assay) for predicting sentinel lymph node metastasis in primary cutaneous melanoma patients: a U.S. cohort study. International Journal of Dermatology (link to Yousaf paper).
Mulder et al., 2019. Validation of a clinicopathological and gene expression profile (CP-GEP) model for sentinel lymph node metastasis in primary cutaneous melanoma. Annals of Oncology 30(suppl 5) 533-363 (link to Mulder paper)