Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the start of the commercialization in Europe of SkylineDx’s innovative Merlin Assay as a CE-IVD marked manual kit. The test, developed by SkylineDx together with the Mayo Clinic (US), aims to predict a melanoma patient’s risk of nodal metastasis and may help safely forgo an invasive surgery, which is now often performed 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. Merlin Assay provides a more personalized insight, identifying patients with a low-risk tumor that could avoid the surgery (1). The Merlin Assay will be commercialized in Europe by Biocartis as a CE-IVD marked manual kit, ahead of the launch of an Idylla™ version of the test which is under development.
Biocartis and SkylineDx, a Dutch (Rotterdam) and US (San Diego, California) based private biotechnology company, announced their partnership agreement on 22 April 2021. Under the terms of the partnership agreement, SkylineDx is leading the development of the Merlin Assay on Idylla™, while Biocartis is leading the commercialization in Europe through its growing Idylla™ network. As part of the commercialization in Europe, Biocartis will now also commercialize the CE-IVD marked manual kit, ahead of the Idylla™ version of the Merlin Assay. In the US, the test is already available as a Laboratory Developed Test serviced from SkylineDx’ CAP/CLIA laboratory. SkylineDx received Medicare reimbursement for the test in May 2022.
Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are very excited to start commercialization in Europe of SkylineDx’s CE-IVD marked manual kit of the Merlin Assay. This manual kit is based on a well-established qPCR method that can easily run in molecular diagnostic laboratories. Although it’s the first time we are commercializing a partner test ahead of an Idylla™ version of the test, this version of the Merlin Assay may offer our European customer base of large molecular diagnostic labs already a clear added value to help improve outcomes for melanoma patients. Once completed, the Idylla™ version of the Merlin Assay is expected to allow an even broader access for melanoma patients across Europe, with reduced time to results.”
Dharminder Chahal, Chief Executive Officer of SkylineDx, replied: “Launching the Merlin Assay as a CE-IVD marked manual kit in Europe signifies a major milestone in making our diagnostic solutions available to patients globally. We are looking forward to enter this new phase of our partnership with Biocartis.”
(1) 2 Bellomo et al., Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precision Oncology (2020). https://doi.org/10.1200/PO.19.00206.