ROTTERDAM, Netherlands and SAN DIEGO, April 22, 2020 /PRNewswire/ -- SkylineDx announced today that the Merlin Assay for melanoma is officially added to their test menu and available as Laboratory Developed Test from their CAP/CLIA lab in San Diego, CA. This announcement follows last week's scientific publication that the test could reduce up to 42% of surgical interventions in patients with the diagnosis melanoma (skin cancer) as it identifies patients at low risk of having metastasis in their sentinel lymph nodes [2-3]. These patients would not need to have their lymph nodes removed for clinical assessment. During and post COVID-19, surgical procedures are deferred whenever this is medically possible and elective staging procedures for melanoma patients such as the sentinel lymph node (SLN) biopsy are sometimes difficult to accommodate. The Merlin Assay could offer a much-needed triage tool to dedicate resources to patients that have the biggest medical need.
"The Merlin Assay is offered as a diagnostic service from San Diego and a report of the test results could be communicated in 5 working days based on the primary tissue material collected from the original biopsy," explains Dharminder Chahal, CEO SkylineDx. "To be able to launch this diagnostic service faster than planned during a global challenge like COVID-19 requires the commitment and engagement of the entire team. The drive of the team to make a difference for patients and their physicians, especially now, resulted in an impressive collaboration with many stakeholders. I am proud that we are able to get the Merlin Assay as LDT on the market in the United States at an accelerated pace."
The Merlin Assay is the first diagnostic test that resulted from the Falcon R&D Program, an R&D centered partnership with clinicians and academia, aimed at the development of tools to optimize the clinical pathway of melanoma patients. More information on www.falconprogram.com.
SkylineDx is a high-tech commercial-stage biotech company headquartered in Rotterdam, the Netherlands and a commercial office and CAP/CLIA certified laboratory in San Diego, California, USA. The company uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility. With the focus on diagnostics, SkylineDx assists healthcare professionals in accurately determining the type or status of the disease or to predict a patient's response to a specific treatment. Based on the test results, healthcare professionals can tailor the treatment to the individual patient. To learn more, please visit www.skylinedx.com.
- Link to this press release on website SkylineDx (click here)
- Bellomo et al., 2020. Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastases in primary cutaneous melanoma. JCO Precis Oncol 4:319-334 (click here)
- 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. Volume 30. Issue Supplement 5, mdz255.014 (click here)