SkylineDx presents first prospective validation data Merlin Test at EADO 2022

ROTTERDAM, Netherlands and SAN DIEGO, April 21, 2022 /PRNewswire/ -- Today, SkylineDx presents new data showing that their Merlin Test was able to prospectively reduce >37% of surgeries in a non-interventional study for newly diagnosed melanoma patients². The Merlin Test identifies melanoma 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 the surgeries, the biopsy comes back negative for metastasis and does not further impact the patient pathway. The Merlin Test provides a more personalized insight on the metastatic propensity of the tumor, patients with a low-risk tumor could avoid the surgery³.

Four melanoma medical centers from the Netherlands led this prospective multicenter innovative study which is currently still ongoing. The study was initiated during the first wave of COVID-19 pandemic to allow for surgical triage on SLNB and to evaluate the implementation of Merlin Test in clinical practice. Results of this prospective trial confirm the performance of previously published European and US retrospective validation studies, in real world practice². The abstract publication is a designated oral presentation during the 18^th Congres of the European Association of Dermato-oncology (EADO) in Sevilla, Spain (April 21^st-23^rd 2022).

"EADO 2022 will be the first European conference that we attend together with our collaboration partner Biocartis," comments Dharminder Chahal, CEO SkylineDx. "It is exciting that in our first collective outreach we are able to show new prospective data that further strengthens the scientific solidity and clinical relevance of our Merlin Test."

About Merlin Test

The Merlin Test uses the CP-GEP model, a powerful algorithm that calculates the risk of metastasis in a patient's sentinel lymph nodes³. 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 independently validated in several cohorts. 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 (including references) 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 USA 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 about SkylineDx, please visit www.skylinedx.com.

Footnotes

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

² Stassen et al., Use of CP-GEP to identify primary cutaneous melanoma patients with a low risk for SN metastasis in a prospective multicenter Dutch study during COVID-19. Oral presentation at EADO 2022, on April 23^rd 9.30AM CEST in room 4 during Free Communication 3: Basic research, genetics and epidemiology of skin cancer (link to abstract).

³ 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