SkylineDx is a biotechnology company, focused on research & development of molecular diagnostics in oncology and inflammatory diseases
Merlin Test reduces unnecessary surgeries. (Credit: Dominik Karch from Pixabay)
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.
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.
Source: Company Press Release