ROTTERDAM, NETHERLANDS and SAN DIEGO, September 1, 2022 /PRNewswire/ — SkylineDx, a leading molecular diagnostics company, today announces the commercial launch of the Merlin Assay as a distributable CE-IVD test kit Europe. Merlin Assay identifies melanoma (skin cancer) patients who have a low risk of lymph node metastasis and can therefore safely do without a sentinel lymph node biopsy (SLNB). This is an invasive surgical procedure used to determine the metastatic spread of the cancer for staging purposes. In about 80% of surgeries, the biopsy is negative for metastases unless it further impacts the patient pathway. The test provides a more personalized insight into the tumor’s propensity to metastasize and identifies patients with a low-risk tumor who could avoid surgery [2]. The CE-IVD device is based on an established qPCR method that can be easily performed in molecular diagnostic laboratories.

This news follows the company’s recent announcement of having received Medicare coverage for the Merlin Assay counterpart The United States, Merlin testcentrally maintained by SkylineDx’s CAP/CLIA lab in San Diego (CA) [3]. The Company is expanding the geographic footprint of its dermatology franchise with commercial operations in key markets United States and Europe. While Merlin test and Merlin Assay are their first and leading products in dermatology, the successive introduction of further dermatological tests is expected [4].

As jointly announced in April 2021Biocartis Group NV will act as SkylineDx commercial distributor for the European market [5].

“Introduction of the Merlin Assay as a manual kit with CE-IVD marking in Europe marks an important milestone in bringing our diagnostic solutions to patients worldwide,” commented Dharminder Chahal, CEO SkylineDx. “We look forward to entering this new phase of our partnership with Biocartis.”

“We are very excited to begin commercialization in Europe of the SkylineDx CE-IVD marked manual kit of the…