qPCR Assay Identifies Melanoma Patients With Low-Risk Tumor That Could Avoid Invasive Biopsy

Melanoma is an aggressive type of skin cancer. Sentinel lymph node biopsy (SLNB) is an invasive surgical procedure used to determine metastatic spread of the cancer for staging purposes. In approximately 80% of surgeries, the biopsy comes back negative for metastasis, where it does not further impact the patient pathway. Now, a new test provides a more personalized insight on the metastatic propensity of the tumor, identifying patients with a low-risk tumor that could avoid the surgery.

SkylineDx’s (Rotterdam, The Netherlands) Merlin Assay identifies melanoma patients that have a low risk for nodal metastasis and therefore can safely forgo a SLNB surgery. The CE-IVD device is based on a well-established qPCR method that can easily run in molecular diagnostic laboratories. Merlin Assay uses the CP-GEP model, a powerful proprietary 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 eight genes from the patient's primary tumor, the tumor thickness and the patient's age; and has been analytically and clinically validated. SkylineDx has announced the commercial launch of Merlin Assay as CE-IVD distributable test kit in Europe.

"Launching Merlin Assay as CE-IVD marked manual kit in Europe signifies a major milestone in making our diagnostic solutions available to patients globally," said Dharminder Chahal, CEO SkylineDx.

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