SkylineDx announces commercial launch Merlin™ Assay as CE-IVD kit in Europe

ROTTERDAM, Netherlands and SAN DIEGO, Sept. 1, 2022 /PRNewswire/ -- Today, SkylineDx, a leading molecular diagnostics company, announces the commercial launch of Merlin Assay as CE-IVD distributable test kit in Europe. 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.

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).

About SkylineDx

SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. The company is headquartered in Rotterdam (the Netherlands) and complemented with a commercial team, a field medical and scientific affairs team and a CAP/CLIA certified laboratory in San Diego (CA, USA). SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. To learn more about SkylineDx, please visit www.skylinedx.com.

Footnotes

1.  Link to this press release on website SkylineDx (click here).

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.

3.  SkylineDx announces Medicare coverage for its predictive melanoma assay Merlin Test (link to press release)

4.  Research and Development pipeline of SkylineDx's dermatology franchise Falcon Program: https://falconprogram.com/

5.  SkylineDx and Biocartis sign collaboration agreement to develop Merlin Assay, a test predicting risk for nodal metastasis in melanoma, on Idylla^TM (link to press release)