How the Dutch resume elective surgery in melanoma after COVID delays
ROTTERDAM (the Netherlands) and SAN DIEGO (US), August 26, 2020: SkylineDx signed a collaboration agreement with a multi-disciplinary clinical consortium in the Netherlands that designed a trial to implement a diagnostic innovation to manage continuity of care delivery when resources are under pressure due to COVID. The diagnostic tool, Merlin Assay, identifies melanoma (skin cancer) patients for whom postponing sentinel lymph node biopsy (SLNB) surgery would be at minimal risk, allowing physicians to better triage care and allocate resources. Around 80% of melanoma patients that undergo an SLNB surgery to check for metastases, have no detectable disease spread, making the surgery redundant. The Merlin Assay uses characteristics from the primary tumor and the patient’s age to calculate if a patient’s risk of having metastases is so low that the surgery can be safely avoided. Reducing up to 42% of these surgeries [2-3], the Merlin Assay enables hospitals to efficiently direct their surgical resources to patients with the highest need, and in case of metastases, prioritize immediate steps on their care path. The consortium consists of 8 Dutch institutes and is led by the Erasmus MC, University Medical Center Rotterdam (EMC).
“Reducing the backlog of regular care and maintaining it, is of utmost importance while we are preparing for a possible new COVID peak”, comments Prof. Dr. Kees Verhoef, Head of Oncology – and Gastrointestinal Surgery at EMC. “Tools that better direct the use of healthcare resources, will make us better equipped to provide adequate cancer care for individual patients at the moment they need it”.
A recent US case study from the Mayo Clinic described the clinical pathway of a melanoma patient that was referred for the SLNB surgery. It took 21 days of extensive use of hospital resources, medical specialists and laboratory tests, including a 90-minute surgery under general anesthetics, to arrive at an SLNB result which turned out to be negative for metastasis. For the same patient, the Merlin Assay, correctly identified the low risk nature of the patient’s melanoma after just a few days . It is an illustrative example of how the diagnostic innovation could impact the patient pathway. The Dutch trial will capture this information in real world setting.
“Better allocation of resources and a faster turnaround time are not the only benefits, using the Merlin Assay in routine clinical practice”, continues Dr. Dirk Grunhagen, Oncological Surgeon at EMC. “The overall complication rate associated with the surgery is between 5-10%. The Merlin Assay may save the low-risk patient group surgical complications and the subsequent care needed”.
“It has been a proud moment to experience how different stakeholders can come together and be innovative in designing and implementing solutions when it is most needed”, comments Dharminder Chahal, CEO of SkylineDx that developed the Merlin Assay. “We are very excited that we were able to contribute by accelerating the access to our diagnostic innovation. With the start of this study, another important step towards personalizing cancer treatment has been taken”.
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. The model has been previously published in JCO Precision Oncology  and validated by the Erasmus MC, University Medical Center Rotterdam . 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, mainly focused on research & development of molecular diagnostics in oncology. 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.
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Bellomo et al., 2020. Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precis Oncol 4:319-334 (link to Bellomo paper)
Mulder & Dwarkasing 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 & Dwarkasing paper)
Letter to the editor by Alexander Meves & Alexander M.M. Eggermont. 2020. Deselecting melanoma patients for sentinel lymph node biopsy during COVID-19: clinical utility of tumor molecular profiling. Mayo Clin Proc Inn Qual Out XXX 20202;..(.):1-2 (link to the letter)