ROTTERDAM (the Netherlands) and SAN DIEGO (US), September 27, 2018: Netherlands Enterprise Agency (“Rijksdienst voor Ondernemend Nederland”), a part of the Ministry of Economic Affairs and Climate Policy, grants through a financial loan (“Innovatiekrediet”) €2.7 million for the development of a diagnostic skin cancer test. Based on genetic information from cancer cells, this skin cancer test predicts if a patient is at risk of having metastases in the lymph nodes. Melanoma is a malignant skin cancer and responsible for 75% [1] of all skin cancer related deaths. The number of melanoma patients increases at a rate of 3 – 7% [2] annually and amongst children and young adults the number of patients increased by more than 250% between 1973 and 2015 [3]. Because incidence levels are rising, there is a high need to select patients for surgery to determine the presence of metastases, and to avoid patients having surgery that have a proven low risk at metastases by a diagnostic test. The development of this reliable diagnostic test will therefore make an important and much needed contribution to the improvement of skin cancer care.

“It is great recognition that the Dutch government, as an independent party, expresses its confidence in our capacity to successfully develop this test and bring value to the doctor and their patients globally,” says Dharminder Chahal, CEO SkylineDx. SkylineDx, a high-tech company in (cancer) diagnostics, is developing the test in collaboration with the research group of Alexander Meves [4], M.D., of the renowned Mayo Clinic, which this year has again been named the best hospital in the United States by the U.S. News and World Report. “Mayo Clinic is a great collaborator. They diagnose and treat skin cancer patients on a daily basis and translate the needs for improvement to help patients. Together we can develop a test that has a significant impact on the entire treatment process,” continues Dharminder Chahal. “We are close to initiating our first clinical validation trials.”

Melanoma is formed in the pigment cells of the skin. Long-term exposure to UV radiation from sunlight and tanning beds increases the risk of melanoma [5]. If a doctor wants to detect melanoma metastases, the nearest lymph nodes are surgically removed to check if they are clean. “A striking 85% [6-7] of these surgeries are unnecessary and 5% [6-7] of patients that do not receive this surgery do have metastases. Our skin cancer test will save society a great deal of healthcare costs by enabling personalized treatment plans and – more importantly – no longer exposes the patient to unnecessary risk of complications from surgical interventions,” concludes Dharminder Chahal.

Footnotes
1. Wouters et al. Crit Rev Oncol Hematol. 2018
2. Cancer Research UK
3. ASCO Abstract 112435
4. Meves et al. Journal of Clinical Oncology. 2015
5. Karimkhari et al. B J Dermatol. 2015
6. Society AC. Cancer Facts & Figures. 2018
7. Gerschenwald et al. CA Cancer J Clin. 2017

About SkylineDx
SkylineDx is a high-tech commercial stage biotech company headquartered in Rotterdam, the Netherlands and a commercial office and laboratory in San Diego, California, USA. The company uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility. With the focus on diagnostics, SkylineDx assists healthcare professionals in accurately determining the type or status of the disease or to predict a patient’s response to a specific treatment. Based on the test results, healthcare professionals can tailor the treatment to the individual patient. To learn more, please visit www.skylinedx.com

SLNB is a standard, yet invasive, procedure used to accurately stage melanoma and guide further treatment. Recommended for patients with melanomas that exceed a Breslow thickness of 1.0 mm, SLNB is crucial in detecting the spread of cancer to the lymph nodes. However, with a relatively low positive detection rate—only 15% to 20% of patients undergoing SLNB have nodal metastasis—many patients undergo the surgery unnecessarily. The Merlin CP-GEP model addresses this issue by identifying patients at low risk for nodal metastasis, allowing them to avoid unnecessary SLNB and its associated risks.

The MIA-led study analyzed data from independent validation studies on the Merlin CP-GEP model published between 2020 and 2024. These studies spanned patient records from 4 countries, offering a comprehensive view of the model’s predictive accuracy. The analysis revealed that the CP-GEP model achieved a sensitivity of 93%, meaning it accurately identified 93% of patients with nodal metastasis, while achieving an NPV (Negative Predictive Value) of 95%, indicating that 95% of patients identified as low-risk truly did not have nodal metastasis. The model performed exceptionally well in patients with pT2 melanomas (1.01 – 2.0 mm thickness) [2], significantly reducing the number of unnecessary SLNB procedures. However, in patients with pT1 melanomas (≤1.0 mm thickness) [2], heterogeneity in the data prevented reliable conclusions, highlighting the need for further research [3], [4]. The study also confirmed that patients with pT3 and pT4 melanomas, due to their high risk of nodal metastasis, are less likely to benefit from the Merlin model, as SLNB is generally recommended for these more advanced cases as the risk for a positive node is higher.

Commenting on the findings,  Associated Professor. Dr. Alexander C.J. van Akkooi, MD, PhD, FRACS, Chair of Melanoma Surgical Oncology at Melanoma Institute Australia and one of the principal investigators, stated, “The data from this independent meta-analysis, consisting of CP-GEP performance across all the studies, shows that Merlin’s CP-GEP model is a powerful deselection tool for SLNB, especially for patients with pT2 melanomas. By reducing surgeries, we’re improving patient care and making melanoma treatment pathways more efficient.”

Jvalini Dwarkasing, Chief Scientific Officer of SkylineDx, added, “This independent validation of our Merlin test by one of the world’s leading melanoma research institutes is an important milestone. It reinforces the clinical utility of the CP-GEP model in optimizing melanoma care, enabling patients to avoid the risks of  surgeries while ensuring that those who need further intervention receive it. We will continue our work to refine and expand the use of Merlin, ensuring its benefits are realized globally.”

SkylineDx remains committed to advancing innovative diagnostic tools like Merlin CP-GEP, helping to personalize treatment decisions and improve outcomes for melanoma patients.

About CP-GEP (Merlin test)
CP-GEP is a non-invasive prediction model for cutaneous melanoma patients that combines clinicopathologic (CP) variables with gene expression profiling (GEP). This model is able to stratify patients based on being high or low risk for metastasis and thereby categorize them in the appropriate surgical action categories listed in evidence-based cancer treatment, prevention and screening guidelines. The CP-GEP model was developed by Mayo Clinic and SkylineDx BV and it has been clinically validated in multiple studies.  More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase the access. In the United States, Tempus is commercializing Tempus Merlin test.
Quest Diagnostics launched their own LDT version of the CP-GEP model in the United States under the brand name MelaNodal Predict™.

About SkylineDx
SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology inflammatory, and infectious diseases. 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. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA. To learn more about SkylineDx, please visit www.skylinedx.com.

Footnotes:

1.T. Wong et. al. Predictive Performance of the Clinicopathologic Gene Expression Profile
(CP-GEP) in Identifying Cutaneous Melanoma Patients for Whom Sentinel Lymph Node Biopsy is Unnecessary: A Systematic Review and Meta-Analysis.  https://falconprogram.com/files/AMC2024%20CP-GEP%20Poster.pdf

2. Understanding Melanoma Staging – Melanoma Research Alliance

3. Sondak et al., Prospective multicenter evaluation (MERLIN_001 trial) of a clinicopathologic and gene expression profile test to predict sentinel node status in T1-T3 cN0 melanoma https://falconprogram.com/files/SMR%202024%20Abstract%20MERLIN_001.pdf;

4. Yu et al. CP-GEP Identifies T1a Melanoma Patients at Risk of Sentinel Lymph Node Metastasis  https://falconprogram.com/files/SMR%202024%20T1a.pdf