Dermtech Inc., of La Jolla, Calif., has had a busy couple of weeks, revealing late last month that its noninvasive melanoma detection test is available for use via telemedicine. Now, the company has unveiled first-quarter results that saw assay revenue of $0.8 million, a 238% increase from the first quarter of 2019.

"While the coronavirus pandemic has impacted our business near term, our long-term growth prospects remain strong and we believe may be enhanced by the broad movement of health care toward telemedicine services,” said John Dobak, CEO of Dermtech, regarding the quarter.

Precision dermatology

The company is playing a pivotal role in helping patients facing a possible melanoma diagnosis. “Dermtech is all about precision dermatology,” Dobak told BioWorld. He noted that dermatology currently relies on invasive procedures, and there are diagnostic inaccuracies and high costs.

That’s where Dermtech is aiming to provide an alternative. “By bringing genomics to the field, we can make the whole diagnostic paradigm much more precise and correct all those existing problems,” Dobak explained.

Indeed, the genomic diagnostic test, known as the Dermtech pigmented lesion assay (PLA), is allowing patients to noninvasively sample a lesion suspicious for melanoma at home via a supervised telemedicine appointment.

The company’s product allows for the collection with an adhesive patch, much like Scotch tape. It collects the upper layer of skin, and the genomic information contained within allows for genomic analysis.

“Effectively, with our platform now, the doctor can identify a mole that might be suspicious for melanoma. And we can then provide them the kit, the adhesive patch, simple enough to apply that the patient[s] can do it themselves. It’s currently done with clinician guidance … and the doctor can get the result back.” A patient only will need to come in for a biopsy if a test is positive.

Dobak went on to highlight the test’s great performance. “Our test has a very high negative predictive value – 99%,” he added.

To that end, the journal SKIN just published proof-of-concept data demonstrating that patients are able to reliably perform remote self-sampling of concerning moles using the Dermtech PLA under physician supervision via telemedicine.

Specifically, 258 eligible melanoma survivors were contacted, and of the 211 who expressed interest in the Dermtech PLA, there were seven cases of self-identified concerning lesions. These were confirmed by a clinician to be suspicious of melanoma. Patients then conducted sample collections using the skin collection kit at home under the supervision of a clinician via telemedicine.

Results showed that skin samples collected by patients enabled successful PLA testing to objectively rule out melanoma in all the cases evaluated.

Good uptake, U.S. focus

“The uptake has been great,” Todd Wood, the company’s chief commercial officer, told BioWorld when asked about the response thus far. “We’ve had our advocates that were using the test prior to COVID. … What this has really exposed is there is an unmet need for telemedicine for this particular category of medicine in dermatology.” This is especially important for the senior population, which may take longer to return to in-office visits. In fact, they may never return once they become more comfortable with remote visits.

Of note, the company said in January that Palmetto GBA Moldx had issued a final local coverage determination for the PLA.

The company is focused on the U.S. for now but sees Europe and Australia as great opportunities. Looking ahead, the company is working on its pipeline of products, with an eye toward addressing skin cancer more broadly, including basal and squamous cell cancers.

Quarterly results

In a release on the company’s results, Dobak noted that the telemedicine option is not expected to immediately make up for testing volume lost as result of stay-at-home orders; however, “we believe this is an important long-term business strategy.”

The company estimated that the implementation of stay-at-home orders starting in March reduced the company’s overall first quarter billable sample volume by about 200 to 300 tests. In addition, the company said April 2020 billable sample volume dropped 56% vs. the same month last year.

Still, the company has not had to furlough or terminate any employees as a result of the pandemic. However, additional increases in headcount will be delayed.

The company also noted that enrollment in its TRUST study exceeded 50% prior to the stay-at-home orders. The study is providing repeat clinical assessments and genomic testing on pigmented lesions suspicious for melanoma that were initially tested negative with the Dermtech PLA. As patients start coming in for in-office visits, the company will continue enrollment. However, there is not a firm timeline for completion.