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DermTech Planning to Pursue LDT Path for Melanoma Test Using OpenArray qPCR

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DermTech announced this week that it has raised $5.6 million in a Series B financing round, which it will use to commercialize its melanoma detection test using Life Technologies' OpenArray quantitative real-time PCR system and to establish a CLIA-certified lab facility in which to offer the assay.

The company has spent several years developing a melanoma identification test, which measures the expression of multiple gene targets in RNA extracted from skin samples collected using custom adhesive strips that non-invasively lift cells from suspicious lesions.

In 2011, after completing initial development of the test using microarrays, the company said it was planning to switch to qPCR for commercial development of the assay, adopting the OpenArray system for an initial proof-of-concept study (PCR 11/17/2011).

At the time, DermTech said it planned to evaluate a number of different PCR platforms for potential use in a commercial version of the test.

This week, the company's President and CEO John Dobak told PCR Insider that DermTech will, in fact, be sticking with OpenArray as it works toward obtaining CLIA certification to offer the assay as a laboratory developed test out of its new facility.

"We are planning to validate the assay on an OpenArray platform to support CLIA certification and will utilize that platform going forward," Dobak said.

In the company's earlier microarray work and its first proof-of-concept study using OpenArray, the melanoma test showed 100 percent sensitivity and 88 percent specificity in distinguishing melanoma from non-melanoma.

Dobak said that the company has since completed additional validation studies that have slightly softened those numbers.

"We are still seeing data that shows the assay is very high performing," he said. "In the early papers, they talked about 100 percent sensitivity. But realistically, nothing is 100 percent sensitive, so at this point we are showing … sensitivity above 95 percent and specificity above 70 percent."

"That's still far better performing than any clinical aid in the area," he added.

Detected and diagnosed early, melanoma is highly curable, but currently used clinical detection methods, while sensitive, can be woefully unspecific, according to DermTech — with only about 3 percent to 10 percent of suspicious lesions actually turning out to be melanoma.

Because there is some uncertainly in terms of how long the CLIA certification process might take, Dobak said DermTech doesn't have a hard timeline for when it will release the test.

But, he said the company is hoping to be able to obtain certification in the next 12 to 15 months.

The company's CLIA plans mark a shift from how DermTech initially planned to market the melanoma test. As of late 2011, company officials said the plan was to launch the test initially in Australia then in Europe, followed by filing for clearance from the US Food and Drug Administration.

Dobak, who has been with the company for about a year, said the decision to go the LDT route will better apply DermTech's resources, without ruling out future development of the test as an FDA-approved kit.

"We wouldn't rule out [the FDA process] at this point," he said. "But we feel that in terms of applying our resources this is the best way to get started, especially since there is overlap in terms of the validation protocols for CLIA and for the FDA context."

DermTech previously said it was working on additional gene expression-based assays, including a potential add-on to the melanoma test that would offer information about tumor stage, as well as assays for other diseases like prostate cancer.

Dobak said research on a melanoma staging assay has continued, but the company's main focus at this point is on the melanoma identification test. He declined to comment on what disease areas might be a next target for commercialization.

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