Skin cancer apps can supplement but not substitute standard medical care, and they require proper vetting using standard validation methods, researchers said.
The company plans to commercialize a gene expression signature to predict recurrence risk in cutaneous squamous cell carcinoma.
With the accreditation, the La Jolla, California-based molecular dermatology firm can provide its services in all 50 states and the District of Columbia.
The company discussed its efforts to grow adoption of its products during a call to discuss second quarter financial results for fiscal year 2018.
The partners are developing and optimizing an algorithm that assesses the likelihood of a patient's cancer progressing to metastasis.
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.
Despite the initial high cost, the firm believes the assay's improved accuracy and sensitivity will sway clinical and payor interest.
The company's PD-L1 IHC 28-8 pharmDx diagnostic can now be used in cases of urothelial carcinoma and squamous cell carcinoma of the head and neck.
The company announced positive coverage decisions from Palmetto GBA, 14 BCBS plans, and Aetna.