ROTTERDAM, Netherlands and SAN DIEGO, Sept. 24, 2019 /PRNewswire/ -- SkylineDx announced at the 32nd Biennial Dermatology Symposium: The O'Leary Meeting 2019 in Rochester (MN, US) the launch of a pilot study it will conduct with the Mayo Clinic to evaluate and optimize its diagnostic services focused on primary cutaneous melanoma (skin cancer). SkylineDx' proprietary diagnostic test combines genetic information from a patient's tumor cells (taken during a diagnostic biopsy) with tumor – and patient specific characteristics. Put together, the test can accurately predict the risk of regional metastasis at the time of melanoma diagnosis. Currently, based on tumor characteristics alone, too many patients are predicted to have metastasis at diagnosis which results in many unneeded surgical interventions, so-called sentinel lymph node biopsies. The SkylineDx diagnostic test identifies patients who can safely forgo this surgical intervention. This pilot study with Mayo Clinic is an usability evaluation and the final step before starting a national trial in the United States in 2020.
This announcement follows the joint development agreement that SkylineDx and Mayo Clinic signed in 2018. "In the last 18 months we have been working with the research group of Alexander Meves M.D., a dermatologist of Mayo Clinic, to fully optimize and develop the test", says Dharminder Chahal, CEO SkylineDx. This extensive collaboration has been part of the Falcon Research & Development Program. As the falcon is known as an intelligent creature with unprecedented senses and skills, this R&D program is uniquely equipped to unveil new, detailed insights in the genomic, pathologic and clinical nature of melanoma. "With melanoma being the deadliest form of skin cancer, the launch of this Falcon Research & Development Program will make an important and much needed contribution to improving patient outcomes in this field," continues Dharminder Chahal.
Under the wings of the Falcon R&D Program, a series of specific studies and projects are initiated to demonstrate clinical utility, aimed at developing and introducing an array of diagnostic utilities, ready for the patient. The first focus area is called the Merlin Study Initiative, which covers clinical research and validation studies for the test that predicts if a patient can safely avoid sentinel lymph node surgery. Furthermore, under the Peregrine Study Initiative, SkylineDx is in advanced stages of research to develop a test that predicts a patient's prognosis and identifies patients that are likely to progress faster and might benefit from early adjuvant therapy.
Dr. Meves and Mayo Clinic have financial interest in the test referenced in this release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and 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.
SOURCE SkylineDx BV