SkylineDx and the Mayo Clinic are conducting a pilot study to evaluate SkylineDx's proprietary skin cancer diagnostic, which combines genetic information from a patient's tumor cells and patient-specific characteristics.
The test can accurately predict the risk of regional metastasis at the time of melanoma diagnosis, according to SkylineDx.
The pilot study is a usability evaluation and represents the final step before starting a national trial in the U.S. in 2020. The study is part of a 2018 joint development agreement between SkylineDx and the Mayo Clinic.
When based on tumor characteristics alone, many patients are predicted to have metastases at diagnosis, leading to unnecessary surgical interventions. The SkylineDx diagnostic test is designed to identify patients who can bypass such sentinel lymph node biopsies, the company said in a statement.