ROTTERDAM (the Netherlands), SAN DIEGO (USA), February 24, 2022: today, SkylineDx announced that their Merlin Test for melanoma patients would have been able to reduce over 59% of surgery-related complications by means of deselecting patients for surgery [2]. The commercially available 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 could therefore have been avoided [3]. Merlin addresses an important clinical unmet need by identifying these patients with a low risk of metastasis at diagnosis and can therefore not only reduce unnecessary surgeries but also associated complications. Results have been published in a peer-reviewed and scientific journal, the International Journal of Dermatology [2].
The authors investigated the rate of complications associated with the SLNB procedure. For a total of 558 patients, electronic medical records were analyzed to determine surgery related complications. Their data shows that SLNB-related complications are relatively common as 17.4% developed at least one complication. The most common complications were seroma (9.3%), infection/cellulitis (4.8%) and lymphedema (4.3%). Moreover, six patients (1.1%) sought help in a hospital’s emergency department within 30 days of surgery and nine patients (1.6%) were readmitted to the hospital within 30 days of surgery. Of the 558 patients, 279 (51%) had a Merlin Test Low-Risk result. Omission of SLNB surgery in these 279 patients would have decreased complications by 59.2%, in this cohort. [2]
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
- Link to this press release on website SkylineDx (click here).
- Hieken et al., Using the Merlin assay for reducing sentinel lymph node biopsy complications in melanoma: a retrospective cohort study. International Journal of Dermatology (2022). https://doi.org/10.1111/ijd.16056
- 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
