Palmetto GBA issued final local coverage determination for the tissue-based, 31-gene expression test, which determines a patient’s risk for metastatic disease.
Using genetic information from cancer cells, SkylineDx is developing its test to predict whether a patient is at risk of having metastases in the lymph nodes,
Skin cancer apps can supplement but not substitute standard medical care, and they require proper vetting using standard validation methods, researchers said.
With the accreditation, the La Jolla, California-based molecular dermatology firm can provide its services in all 50 states and the District of Columbia.
As part of the approval, DermTech will market and sell the pigmented lesions assay in Canada, while samples will be processed at the company's lab in California.
Having demonstrated their ATR-FTIR technique in mice, the researchers are moving to human samples and they plan to be in clinical trials in around two years.
