SkylineDx Gains CE-IVD Mark for Melanoma Metastasis Risk Assay
Source: Genome Web, September 2022
NEW YORK — SkylineDx said on Thursday that it has obtained CE-IVD marking for its Merlin Assay to predict which melanoma patients are at low risk of nodal metastasis.
The Rotterdam, Netherlands-based company said the qPCR assay identifies who can safely forgo sentinel lymph node biopsy surgery to detect metastatic spread of cancer for staging purposes, which comes back negative in about 80 percent of cases.
SkylineDx and Belgian firm Biocartis previously announced plans to partner on commercialization of the test in Europe on Biocartis’ Idylla platform. The agreement included a €10 million investment from Biocartis into secured convertible notes to be issued to SkylineDx in project-based installments.