SkylineDx further expands its footprint in the United States

ROTTERDAM (the Netherlands), SAN DIEGO (US), March 23, 2021: SkylineDx received the first Merlin Assay clinical test requests and therefore reported initial gross sales ahead of the commercial launch at the World Congress of Melanoma (WCM) in the United States. This announcement follows the news that SkylineDx obtained US market authorization for this skin cancer (cutaneous melanoma) diagnostic device, last year. To further expand its commercial footprint and intensify payor engagement, SkylineDx is investing in building their US melanoma sales organization and hired the first leadership positions. The company formally launches the Merlin Assay with a symposium at WCM on Friday April 16^th, 2021 at 8-9AM CET: Refining the role of SLNB.

SLNB or Sentinel lymph node biopsies are commonly advised for melanoma patients as it is crucial to determine if the cancer has spread. However, in 80-85% of cases [2], no nodal metastases are found, making this invasive surgery under general anesthesia redundant. The Merlin Assay identifies patients that can safely forgo this procedure [2]. Besides not putting these patients through surgery, the Merlin Assay also takes away the greater-than 10% risk of surgery-related complications [3] and, in times when healthcare resources are under pressure, enables the hospital to redirect care to patients with the highest need. The Merlin Assay is developed in a large US patient cohort [2] and has been independently validated [4-5].

“It takes years of development to present a standardized, reliable molecular test with a strong performance that addresses an unmet medical need. And it really comes together when physicians order the test for their patients to truly use it in their clinical practice”, says Dharminder Chahal, CEO SkylineDx. “I am excited to see how the team is building our melanoma dedicated sales force, increasing our ability to reach and inform all the dermatologists.”

About Merlin Assay

The Merlin Assay uses the CP-GEP model, a powerful algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes. 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. Further clinical research and validation studies on the predictive use of the CP-GEP model is the main focus of the Merlin Study Initiative, developed under the wings of the Falcon R&D Program. More information on www.falconprogram.com.

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 field medical and scientific affairs team in the US and a CAP/CLIA certified laboratory in San Diego (California). 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 predict a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. To learn more, please visit www.skylinedx.com.  

Footnotes

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

2. Bellomo et al., 2020. Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precision Oncology 4:319-334 (link to Bellomo paper).

3. Moody et al., 2017. Complications of sentinel lymph node biopsy for melanoma – A systematic review of the literature. European Journal of Surgical Oncology 43 (2): p270-277 (link to Moody paper). Ascha et al., 2017. Identification of risk factors in lymphatic surgeries for melanoma – A national surgical quality improvement program review. Annals of Plastic Surgery 79 (5): p509-515 (link to Ascha paper).

4. Mulder et al., 2020. Validation of a clinicopathological and gene expression profile model for sentinel lymph node metastasis in primary cutaneous melanoma. British Journal of Dermatology (link to Mulder paper).

5. Yousaf et al., 2020. Validation of a model combining clinicopathologic risk factors and a gene expression profile to identify primary melanoma patients who can safely forgo sentinel lymph node biopsy. Abstract ESMO conference (link to ESMO poster).

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