Independent validation of performance Merlin Test in Swedish patients

ROTTERDAM, Netherlands and SAN DIEGO, March 24, 2022 /PRNewswire/ -- Today, SkylineDx announced that their Merlin Test for melanoma patients was independently validated in a Swedish (European) cohort, where it could reduce approximately a third of the surgeries in the clinically most relevant patient group (patients with pT1-2 melanomas) ^[2]. The Merlin Test identifies melanoma patients that can safely forgo a sentinel lymph node biopsy (SLNB) surgery, a procedure used to determine metastatic spread of the cancer for staging purposes. In approximately 80% of patients 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. The patient with a low-risk tumor could avoid surgery ^[3]. Results have been published in a peer-reviewed and scientific journal, the European Journal of Surgical Oncology ^[2].

"We have now validated our Merlin Test in four independent cohorts, two in the United States and two in Europe, showing clinically impactful reduction rates of invasive surgeries," comments Dharminder Chahal, CEO SkylineDx. "We are currently also investigating whether Merlin's algorithm, CP-GEP, may guide decision-making beyond nodal assessment. Our Chief Scientific Officer, Dr. Jvalini Dwarkasing, will give an abstract presentation at AAD 2022 Annual Meeting about the use of CP-GEP in cutaneous melanoma patients with minimal tumor burden in the sentinel nodes ^[4]."

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 nodes ^[3]. 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. Johanssen et al., Validation of a clinicopathological and gene expression profile model to identify patients with cutaneous melanoma where sentinel lymph node biopsy is unnecessary. European Journal of Surgical Oncology (2022). https://doi.org/10.1016/j.ejso.2021.11.010
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
4. American Academy of Dermatology 2022 Annual Meeting, session S022 – Residents and Fellows Symposium. Saturday, March 26 at 10.42AM EDT, Location 162B. https://am2022.aad.org/sessions/3756