If a doctor suspects a mole or skin spot might be cancerous, she would usually give the patient a local anesthetic, cut out or shave off a sample of the skin and send it to a lab for testing. With a new test being developed by biotechnology company DermTech, that sample could be taken without an anesthetic or a procedure that leaves a scar.
DermTech’s test uses an adhesive tape to collect cells from the suspected skin’s surface. When the sample is sent to DermTech’s labs, technicians extract RNA and analyze it for 17 expressions that indicate the presence of melanoma, with results delivered in about three days.
With the first closing of a $5.6 million series B, La Jolla, California-based DermTech hopes to complete commercial validation of its assays and receive CLIA licensure for the labs where those assays would be done. President and CEO Dr. John Dobak said he expects that to happen within the next 12 months.
According to the American Cancer Society, melanoma is the fastest-growing cancer in the U.S., with more than 63,000 diagnoses made each year. If it’s recognized and treated early, it’s highly curable.
Skin biopsy rates have gone up over the last 15 years, but clinical diagnostic accuracy has remained a challenge. Only a small percentage of the number of biopsies taken yield actual melanoma diagnoses.
A device designed to screen skin lesions noninvasively, to help doctors decide when a biopsy is necessary, was cleared by the U.S. Food and Drug Administration in 2011. But the device, MelaFind, has come under scrutiny from dermatologists who say visual examinations with a dermatoscope are still the best ways to examine a suspect spot.
In clinical studies, DermTech’s assays demonstrated 95 percent sensitivity in distinguishing melanoma from non-melanoma samples, the company said.
[Image credit: Flickr user Christiana Care]