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SkylineDx Gains CE-IVD Mark for Melanoma Metastasis Risk Assay

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.

In a separate announcement, Biocartis said on Thursday that it will start commercializing the test, which had been developed through a collaboration between SkylineDx and the Mayo Clinic, in Europe as a CE-IVD marked manual kit ahead of the launch of an Idylla version that remained under development.

SkylineDx recently obtained Medicare coverage for the Merlin test in the US, where it runs as a laboratory-developed test in SkylineDx's CAP-accredited, CLIA-certified lab in San Diego.

The assay uses an algorithm to analyze eight genes from the patient's primary tumor, the thickness of the tumor, and the patient's age to calculate the risk of metastasis in a patient's sentinel lymph nodes. The company is conducting further research and validation studies into predictive use of the model.

SkylineDx CEO Dharminder Chahal said in a statement that launching the assay in Europe "signifies a major milestone in making our diagnostic solutions available to patients globally." Biocartis CEO Herman Verrelst said the assay will help customer laboratories and hospitals in Europe improve outcomes for melanoma patients.

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