A Step Before the Scalpel
Melanoma is deadly if not caught early. But it’s very difficult to visually detect. So it’s no wonder that the status quo was to biopsy any mole that looks remotely suspicious. That leads to a lot of cutting. But not a lot of accuracy — 96% of biopsies taken test negative for melanoma.* And 17% of the time, early stage melanoma is missed altogether.1
Now, there’s a step before the scalpel. The DermTech Melanoma Test is extremely accurate, with a 99% negative predictive value (that is, a 99% probability that a negative test means you really don’t have the disease).2
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3 Steps to DermTech It
LIFT
You and your doctor use a series of smart stickers to painlessly collect skin cells from a suspicious mole — no scalpel needed. This can be done at a doctor’s office, or remotely via telehealth with your doctor’s supervision.
TEST
At DermTech’s Gene Lab, a proprietary process looks for the presence of elevated expression levels of two genes proven to correlate with melanoma, named LINC00518 and PRAME.
KNOW
Results are sent to your physician in about 3 business days. Your doctor will use this information to choose the best path forward for your treatment. If the genomic markers are there, this will typically result in removal of the mole. If not, you’ve likely saved yourself a scar.
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Looks Simple,
Acts Revolutionary
The adhesive not only lifts the genomic material, but stores and preserves it so it can be simply sent to DermTech’s Gene Lab for examination.
Unlike a biopsy, which evaluates only 1-2% of the mole, DermTech’s smart sticker captures cells from 100% of the mole’s surface.9
Unlike a biopsy, which evaluates only 1-2% of the mole, DermTech’s smart sticker captures cells from 100% of the mole’s surface.9
The sticker, shown with actual skin tissue.
A Different Kind of Lab
At DermTech’s dedicated on-site lab, a team of experts and Clinical Laboratory Scientists (CLS) oversee a fully automated testing process run by state-of-the-art, proprietary instrumentation.
A custom designed space in La Jolla, California, the Gene Lab is the first and only commercial lab to extract nucleic acid (and other proteins) from non-invasive skin samples.
When the sticker samples arrive here, they undergo an automated process that amplifies RNA molecules. The following analysis determines if one or both genes that are highly predictive of melanoma, PRAME and LINC00518, are detectable in the sample.10
DermTech Chief Operating Officer Claudia Ibarra runs the Gene Lab.
DermTech Chief Operating Officer Claudia Ibarra runs the Gene Lab.
More Than the
Eye Can See
Cancer starts when genes mutate within a cell. This altered cell duplicates and duplicates until enough cells exist to be seen under a microscope (and then, eventually, even without one). DermTech’s genomic analysis can find these altered cancerous cells long before they show up under a microscope, through a proprietary gene expression test.11
The expression test to search for PRAME and LINC00518 is done through an amplification process called RT-PCR (a polymerase chain reaction) that makes billions of copies of these genes so our scientists can study them in detail.12,13 When this analysis shows excessive levels of the PRAME and/or LINC00518 gene, it correlates with the presence of melanoma.14
The Tech is Advanced
The Process is Easy
When ordered by your doctor, the test can be done remotely under your doctor’s supervision. Here are the easy steps.
Press the sticker on top of your mole
Lift the sticker off in one direction
Press and rub the spot
Stick it on the collection strip
Circle the spot
Done and done
Press the sticker on top of your mole
Press and rub the spot
Circle the spot
Lift the sticker off in one direction
Stick it on the collection strip
Done and done
More Genomic Tests in Development
What else could the smart sticker do?
DermTech:
Carcinome
Find the presence of non-melanoma skin cancers at the genomic level. The Carcinome test is currently in development.
DermTech:
LuminateSM
Identify UV damage at the genomic level. The LuminateSM test is currently in development.
Frequently Asked Questions
What is the DermTech Melanoma Test (PLA)?
The DermTech Melanoma Test is a new kind of lab test that looks for signs of melanoma in your skin’s genomic material. With the traditional biopsy care pathway, clinicians use their eyes — aided by a microscope — to see physical changes to a mole, and the cells within it. The DermTech test uses a gene expression test to analyze the RNA inside those cells.
Because it can find indications of melanoma at this more precise level, the disease can be detected far earlier than the current biopsy pathway.17
The DermTech Melanoma Test uses a smart sticker to pull skin tissue off the entire surface of the mole painlessly and without an incision.
How does it work?
If your doctor has identified a suspicious skin spot — maybe one they would normally take a photograph of and track — they can use the DermTech Melanoma test to rule out melanoma (with 99% accuracy, better than the 83% accuracy of the current biopsy care pathway).18,19
Once they have identified the spot, they’ll open the “Adhesive Skin Collection Kit” to begin the test. They’ll use the smart sticker to lift skin tissue off the spot by pressing, rubbing, and lifting the sticker. They’ll do this four times, placing each sticker on the collection strip.
This strip then gets sent to our Gene Lab. At the lab, a DermTech patented process tests your sample for expression levels of two specific genes associated with melanoma, named PRAME and LINC00518.
Results are sent to your physician in about 3 business days. Your doctor will use this information to choose the best path forward for your treatment. If the genomic markers are there, this will typically result in removal of the spot. If not, you’ve likely saved yourself a scar.
Does the DermTech Melanoma Test hurt?
Not typically. The sticker uses a proprietary adhesive to lift 1.5 mg of tissue off the top layer of your skin, but it’s not so strong that it would cause pain, bleeding or damage to the site. In certain cases, mild irritation or other effects may occur.
Does the DermTech test replace a biopsy?
The DermTech Melanoma Test is not a replacement for a biopsy. If the genomic markers are there, your doctor will use this information to choose the best path forward for your treatment. This will likely result in removal of the mole. The DermTech Melanoma Test is rather a step before a biopsy that can see indicators of the disease far earlier than the traditional biopsy pathway can.20
Learn more about DermTech’s Melanoma Test.
And stay up-to-date on other treatments and technology.
Ask for a more advanced test.
Get your skin checked with a doctor who can DermTech It.
* DermTech, data on file
** DermTech, data on file
*** In certain cases, mild skin irritation or other effects may occur.