Independent study shows favorable long term prognosis for CP-GEP Low Risk melanoma patients

ROTTERDAM, Netherlands and SAN DIEGO, March 17, 2023 /PRNewswire/ -- SkylineDx, an innovative diagnostics company, focused on research & development of molecular diagnostics for oncology and inflammatory diseases, today announced the publication of an independent study showing that gene expression profiling (CP-GEP model) can be used to identify primary cutaneous melanoma patients with a high risk for disease recurrence.

The University of Tuebingen (Germany) study analyzed 543 patients diagnosed with stage I/II primary cutaneous melanoma between 2000 and 2017. It found that when combined with clinicopathologic factors, the CP-GEP model can be used to stratify these patients into high risk and low risk cohorts for disease recurrence. Specifically, the patients determined to have Low Risk have an almost five times favorable 5-year recurrence free survival (RFS) over the CP-GEP High Risk patients in stage I/II melanoma, with 93% of low-risk patients are recurrence-free 5 years after diagnosis [2].

Although the research was focused on patients with a negative sentinel lymph node biopsy (SLNB), a separate analysis on patients with very thin melanomas and unknown SLNB status also demonstrated CP-GEP's ability to significantly stratify CP-GEP Low Risk from High Risk patients among this group. The publication supports the value of diagnostic information over a long-term period following the initial diagnosis. Outcomes of this study were published earlier this year by the European Journal of Cancer [2].

"We are encouraged by the study's findings, which support the potential prognostic utility of the Merlin test to inform patient consultation related to disease recurrence," comments Dharminder Chahal, CEO of SkylineDx. "The Merlin test can drive a profound economic benefit by significantly reducing the number of SLNB procedures performed on Low Risk melanoma patients. As we strive to present a complete view of the utility of the Merlin test, this research is an important addition to its clinical dossier."

The CP-GEP model used in the study is an innovative integrated algorithm that combines clinicopathological features with gene expression of the primary melanoma. SkylineDx launched a diagnostic test, Merlin, based on this model  in the United States, where it is currently covered by Medicare. It also launched in Europe last year, as a CE-IVD kit. Merlin is used to identify patients (T1-T2 melanoma) at Low Risk for nodal metastasis that may forgo invasive sentinel lymph node biopsy (SLNB) surgery. SLNB surgery is used to determine metastatic spread of the cancer for staging purposes and is negative in approximately 80% of cases [3]. This University of Tuebingen research shows CP-GEP's potential to replace SLNB in patients that did not undergo the procedure [2].

About the Merlin test

The Merlin test uses the CP-GEP model, a powerful proprietary 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 analytically and clinically validated. The main focus of the Merlin Study Initiative, developed under the wings of Falcon R&D Program, is to conduct further clinical research and validation studies on the predictive use of the CP-GEP model. More information (including references) may be obtained at www.falconprogram.com. The Merlin test is commercially available and reimbursed by Medicare 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. 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.

Link to this press release on website SkylineDx can be found here.

Footnotes

1.  Amaral et al., Identification of stage I/II melanoma patients at high risk for recurrence using a model combining clinicopathologic factors with gene expression profiling (CP-GEP). European Journal of Cancer (2023). https://doi.org/10.1016/j.ejca.2022.12.021.

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.