Press release Biocartis Group NV

Biocartis and SkylineDx Sign Collaboration to Develop the Merlin Assay, a Test Predicting Risk for Nodal Metastasis in Melanoma, on Idylla

PRESS RELEASE:  REGULATED-INSIDE INFORMATION
22 April 2021, 07:00 CEST

Biocartis and SkylineDx Sign Collaboration to Develop the Merlin Assay, a Test Predicting Risk for Nodal Metastasis in Melanoma, on Idylla

Mechelen, Belgium, 22 April 2021 - Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), and SkylineDx, a Dutch (Rotterdam) and US (San Diego, California) based private biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases, today announce the signing of a new partnership agreement which targets the development of SkylineDx’ novel proprietary test, the Merlin Assay, on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla. This assay is aimed at predicting a patient’s risk of nodal metastasis in melanoma. Under the terms of the partnership agreement, SkylineDx will lead the development of the Merlin Assay on Idylla, while Biocartis will lead the commercialization in Europe through its growing Idylla network.

Melanoma is the deadliest form of skin cancer¹ and incidence rates are substantial in Europe with approx. 144k cases/year², in the US with approx. 100k cases/year³ and in Australia with approx. 16,000 cases/year⁴. When diagnosed, prognosis and treatment decisions depend on disease staging⁵. Current staging methods include performing an SLN (sentinel lymph node) biopsy⁶, which is an invasive surgical intervention under general anesthesia, carrying a >10% risk of complications⁷. Moreover, 80-85% of SLN biopsies appear unnecessary as no nodal metastases are found⁸.

The Merlin Assay aims to reduce the number of unnecessary SLN surgeries through the combination of gene expression (from the primary melanoma) with the patient’s age and tumor thickness, allowing the identification of patients at low risk of nodal metastasis⁸. As such, the Idylla Merlin Assay would provide a rapid and easy-to-use tool for physicians to identify patients who may safely forgo the SLN biopsy procedure.

Today, the Merlin Assay is already available as a Laboratory Developed Test in SkylineDx’ CAP/CLIA laboratory in San Diego (California, US). For Europe, a molecular subtyping test kit for in vitro diagnostic use, mainly addressing centralized expert laboratories is under development and will be commercialized by Biocartis ahead of the Idylla version of the assay. Building on Idylla’s decentralization capabilities, the Idylla version of the Merlin Assay will allow improved access for patients across Europe while reducing time to results.