On September 1, 2022 SkylineDx, a leading molecular diagnostics company, reported the commercial launch of Merlin Assay as CE-IVD distributable test kit in Europe (Press release, SkylineDx, SEP 1, 2022, View Source [SID1234618925]). Merlin Assay identifies melanoma (skin cancer) patients that have a low risk for nodal metastasis and therefore can safely forgo a sentinel lymph node biopsy (SLNB) surgery . This is an invasive surgical procedure used 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. The test provides a more personalized insight on the metastatic propensity of the tumor, identifying patients with a low-risk tumor that could avoid the surgery [2]. The CE-IVD device is based on a well-established qPCR method that can easily run in molecular diagnostic laboratories.
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This news follows the company’s recent announcement of having obtained Medicare coverage for Merlin Assay’s counterpart in the United States, Merlin Test, serviced centrally from SkylineDx’s CAP/CLIA laboratory in San Diego (CA) [3]. The company is expanding its dermatology franchise’s geographical footprint with commercial activities in the key markets United States and Europe. Whilst Merlin Test and Merlin Assay are their first and lead products in dermatology, successive introductions of additional dermatology tests are anticipated [4].
As jointly announced in April 2021, Biocartis Group NV will act as SkylineDx’s commercial distribution partner for the European market [5].
"Launching Merlin Assay as CE-IVD marked manual kit in Europe signifies a major milestone in making our diagnostic solutions available to patients globally," comments Dharminder Chahal, CEO SkylineDx. "We are looking forward to enter this new phase of our partnership with Biocartis."
"We are very excited to start commercialization in Europe of SkylineDx’s CE-IVD marked manual kit of the Merlin Assay. In Europe we have long-standing relationships with our customer base of labs and hospitals. This very innovative Merlin Assay will now allow our customers to improve outcomes for melanoma patients," concludes Herman Verrelst, CEO Biocartis.
About Merlin Assay
Merlin Assay uses the CP-GEP model, a powerful proprietary algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes [2]. The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age; and has been analytically and clinically validated. Further clinical research and validation studies on the predictive use of the CP-GEP model is the main focus of Merlin Study Initiative, developed under the wings of Falcon R&D Program. More information (including references) may be obtained at www.falconprogram.com. Merlin Assay’s US counterpart, Merlin Test, is commercially available and Medicare reimbursed as a Laboratory Developed Test serviced from SkylineDx’s CAP/CLIA laboratory in San Diego (CA).