DermTech, a molecular testing startup, has completed Clinical Laboratory Improvement Amendments (CLIA) licensure for its laboratory in California and released validation data for its melanoma test. DermTech’s molecular test focuses on the genetic expression of melanoma. The disease has been diagnosed for decades through the tracking of the shapes and colorations of moles and other skin lesions, followed by biopsies. The DermTech assay uses an adhesive patch to lift tissue from a suspect mole, rather than require a full biopsy. According to data recently released by the San Diego-based company, the test demonstrated a 91 percent accuracy rate in detecting melanoma in moles and lesions in more than 500 sample tests, significantly higher than the current clinical rates based on pigmentation and shape. “DermTech’s gene classifier has the potential to facilitate the assessment of pigmented lesions and significantly reduce surgical biopsies,” said Pedram Gerami, M.D., associate professor of dermatology at Northwestern University and the co-director of melanoma research at the Northwestern Skin Cancer Institute. About 76,000 cases of melanoma are diagnosed in the United States annually, and about 9,700 die from the disease every year. It is by far the deadliest form of skin cancer, although the long-term survival rates […]
DermTech, a molecular testing startup, has completed Clinical Laboratory Improvement Amendments (CLIA) licensure for its laboratory in California and released validation data for its melanoma test.
DermTech’s molecular test focuses on the genetic expression of melanoma. The disease has been diagnosed for decades through the tracking of the shapes and colorations of moles and other skin lesions, followed by biopsies. The DermTech assay uses an adhesive patch to lift tissue from a suspect mole, rather than require a full biopsy.
According to data recently released by the San Diego-based company, the test demonstrated a 91 percent accuracy rate in detecting melanoma in moles and lesions in more than 500 sample tests, significantly higher than the current clinical rates based on pigmentation and shape.
“DermTech’s gene classifier has the potential to facilitate the assessment of pigmented lesions and significantly reduce surgical biopsies,” said Pedram Gerami, M.D., associate professor of dermatology at Northwestern University and the co-director of melanoma research at the Northwestern Skin Cancer Institute.
About 76,000 cases of melanoma are diagnosed in the United States annually, and about 9,700 die from the disease every year. It is by far the deadliest form of skin cancer, although the long-term survival rates exceed 80 percent when the disease is detected in its earliest stages.
DermTech began validation testing for CLIA certification last fall, not long after it raised $5.6 million in series B financing. It has not said when its test will become commercially available in the United States.
Takeaway: DermTech is moving toward a noninvasive test for melanomas, although there is still no estimated timeline for its release.
