Scienza e Tecnologia
Performance Merlin Assay confirmed in independent US validation cohort
The use of the Merlin Assay at diagnosis in routine clinical practice, enables a physician to defer health care resources to patients that have a higher-risk of nodal metastasis, save health care costs and reduce unnecessary surgery related lifelong complications. The results of this second independent validation study, have now been published in the peer-reviewed International Journal of Dermatology.
"After our 2020 publication of the first independent validation study in a European cohort in the British Journal of Dermatology ", comments Dharminder Chahal , CEO SkylineDx, "the team and our collaboration partners were able to confirm Merlin's strong performance in a U.S. cohort as well. This means we can continue with the next steps in our reimbursement strategy".
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.
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.
Link to this press release on website SkylineDx (click here).
Yousaf et al., 2021. Validation of CP-GEP (Merlin Assay) for predicting sentinel lymph node metastasis in primary cutaneous melanoma patients: a U.S. cohort study. International Journal of Dermatology (link to Yousaf paper).
Mulder et al., 2019. Validation of a clinicopathological and gene expression profile (CP-GEP) model for sentinel lymph node metastasis in primary cutaneous melanoma. Annals of Oncology 30(suppl 5) 533-363 (link to Mulder paper)
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).