SkylineDx is a Dutch (Rotterdam) and US (San Diego, California) based private biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. Biocartis and SkylineDx announced their partnership agreement on 22 April 2021 which targets the development of SkylineDx’ novel proprietary test, the Merlin™ Test, on the Idylla™ platform.
Melanoma
Melanoma is the deadliest form of skin cancer1 and incidence rates are substantial in Europe with approx. 144,000 cases/year2 , in the US with approx. 100,000 cases/year3 and in Australia with approx. 16,000 cases/year.4 When diagnosed, prognosis and treatment decisions depend on disease staging. Current staging methods include performing a sentinel lymph node biopsy5 to determine if cancer cells from the original tumor have started to spread. The sentinel nodes are the first few lymph nodes to which a tumor spreads. A sentinel lymph node (SLN) biopsy is an invasive surgical intervention which involves injecting a tracer material to locate the sentinel nodes during surgery which are then removed and sent for analysis to determine whether metastatic cells are present. Approximately 80-85% of SLN biopsies appear unnecessary as no nodal metastases are found.6 Moreover, SLN biopsies carry a >10% risk of complications7 which may result in hospital readmission, negatively affecting patient outcomes and potentially affecting surgical procedure reimbursement.
- 1https://www.nccn.org/patients/guidelines/content/PDF/melanoma-patient.p…
- 2http://www.melanomapatientnetworkeu.org/melanoma.html
- 3https://seer.cancer.gov/statfacts/html/melan.html
- 4https://www.canceraustralia.gov.au/cancer-types/melanoma/statistics
- 5https://www.mayoclinic.org/tests-procedures/sentinel-node-biopsy/about/…
- 6https://ascopubs.org/doi/10.1200/PO.19.00206
- 7https://journals.lww.com/annalsplasticsurgery/Abstract/2017/11000/Ident…
Merlin™ Assay
The Merlin™ Assay aims to reduce the number of unnecessary SLN surgeries by calculating risk of nodal metastasis using the proprietary algorithm CP-GEP that combines a gene expression profile (from the primary melanoma) with clinical and pathological parameters.1 As such, the Idylla™ Merlin Test would provide a rapid and easy-to-use tool for physicians to identify patients who may safely forgo the SLN biopsy procedure. In a multicenter prospective trial, the Merlin™ Assay was shown to be able to reduce >37% of lymph node surgeries in newly diagnosed melanoma patients, thereby confirming the performance of the Merlin™ Assay, as previously published in European and US retrospective validation studies, in real-world practice [Reference to Eado paper] 2 . Today, the Merlin™ Assay is already available as a Laboratory Developed Test in SkylineDx’ CAP/CLIA laboratory in San Diego (California, US). For Europe, a manual kit version of the Merlin™ Assay, mainly addressing centralized expert laboratories, is under development for in vitro diagnostic use and will be commercialized by Biocartis ahead of the Idylla™ version of the test. Building on Idylla™’s decentralization capabilities, the Idylla™ version of the Merlin™ Assay will allow improved access for patients across Europe while reducing time to results.
- 1https://ascopubs.org/doi/10.1200/PO.19.00206
- 2[2] Results of this prospective trial confirm the performance of previously published European and US retrospective validation studies, in real world practice
What our Partner says about the collaboration
Through this collaboration with Biocartis, we enable a broader availability of our test portfolio in melanoma. SkylineDx focuses on precision diagnostics for all cancer patients and with the addition of this new version of our Merlin Test, more laboratories and care settings will be able to have access to this test. Our teams are fully up to speed and we really look forward to start the development process together
Dharminder Chahal, Chief Executive Officer of SkylineDx
