ROTTERDAM, Netherlands and SAN DIEGO, April 15, 2020 /PRNewswire/ -- SkylineDx in collaboration with the Mayo Clinic published yesterday its first study describing a diagnostic test that could reduce up to 42% of surgical interventions used to diagnose patients with melanoma (skin cancer). "Typically, when treating patients with melanoma, surgeons remove lymph node(s) to check for metastasis and determine the patient's disease stage and best treatment strategy," explains Alexander Meves, M.D., a dermatologist at Mayo Clinic Rochester (MN) and senior author. "However, studies have shown these surgeries do not consistently provide additional diagnostic information." The diagnostic test being developed by SkylineDx and Mayo Clinic identifies patients who are at low risk of metastasis in their lymph nodes and will not benefit from surgical removal of their lymph nodes, the study finds. "These patients may therefore be able to forgo the procedure," says Dr. Meves .
Dr. Meves adds that the performance of this diagnostic test has already been validated in an independent European dataset presented at the European Society of Medical Oncology conference in 2019, which confirmed the test's ability to identify these specific patients . The test calculates a patient's risk of nodal metastasis 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. Design of the test's underlying algorithm, a biological assertion of the genes involved and the performance of the diagnostic test, have been published in an open access manuscript in the peer reviewed journal, JCO Precision Oncology .
"This is the first peer reviewed article generated within our extensive melanoma collaboration, called the Falcon Research & Development Program," says Dharminder Chahal, CEO SkylineDx. "It demonstrates the scientific and clinical robustness of our invention, and we can now shift focus onto bringing the independent validation data and the results of our clinical utility studies into the public domain. In the meantime, our teams have advanced the development of the test, to ensure it can be available to patients and physicians at the shortest timeframe possible," concludes Dharminder Chahal.
Dr. Meves reports a financial interest in the test being developed by SkylineDx. Mayo Clinic has reviewed this relationship and taken appropriate steps to protect the scientific integrity of the research.
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.
1. Link to this press release on website SkylineDx (click here)
2. 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)
3. 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)
SOURCE SkylineDx BV