Performance Merlin Assay confirmed in independent US validation cohort

ROTTERDAM (the Netherlands), SAN DIEGO (US), April 30, 2021: SkylineDx announced that the performance of their melanoma diagnostic test (Merlin Assay) is confirmed in an independent group of U.S. patients from the Mayo Clinic and West Virginia University [2]. All newly diagnosed primary cutaneous melanoma patients in this cohort were referred to undergo the sentinel lymph node biopsy (SLNB) procedure. This is a surgical procedure under general anesthetics that removes the sentinel lymph nodes to determine if the disease has spread. For approximately 80% of the patients in this cohort, the invasive surgery was redundant as they did not have nodal metastasis. On the basis of the primary tumor, the Merlin Assay was able to retrospectively identify 37% of these patients without nodal metastasis, meaning that if the Merlin Assay would have been available at diagnosis, these patients could have safely forgone the procedure.

In the subpopulation of patients 65 years and older with T1 and T2 melanomas, Merlin Assay was able to achieve a reduction of 43.1% of unnecessary surgeries, while having a high negative predictive value (or the probability that the negative screening is truly correct) of 95.5% [2]. This elderly subpopulation is of specific clinical interest as the incidence of melanoma is higher among elderly, while also the risk for surgery related complications might increase with age.

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 [3]”, 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.

About Merlin Assay

The Merlin Assay uses the CP-GEP model, a powerful algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes [4]. 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.

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 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.  

Footnotes

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

2. 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).

3. 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)

4. 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).

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