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RISK INFORMATION

Indications for Use

Pigmented Lesion Assay® is intended for use on melanocytic skin lesions with one or more clinical or historical characteristics suggestive of melanoma, including one or more of the ABCDE criteria when a clinician trained in the clinical diagnosis of skin cancer is considering the need for biopsy to rule out melanoma.  The Pigmented Lesion Assay should not be used on clinically obvious melanoma.  The Pigmented Lesion Assay is one element of the overall clinical assessment and should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy.

 

Important Risk Information

The PLA should not be used if you:

  • have a lesion where the skin is ulcerated or bleeding
  • have a lesion that contains a scar or was previously biopsied
  • have a lesion located in areas of psoriasis, eczema or similar skin conditions
  • have a lesion that was already clinically diagnosed as melanoma or for which the clinical suspicion is sufficiently high that the treating clinician believes melanoma is a more likely diagnosis than not
  • where a lesion is located on the palm of hands, soles of feet, nails, mucous membranes and hair covered areas that cannot be trimmed

Talk to your provider to see if any of these situations apply to you.

The PLA test result should be interpreted with caution and by a licensed provider only. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for biopsy. The current care standard of establishing diagnoses of pigmented lesions is provided by a biopsy and by histopathologic assessment of the obtained tissue.

A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their healthcare provider an appropriate follow-up and/or treatment plan. The PLA’s test performance is very high (the negative predictive value of the PLA is over 99% meaning that a lesion that tested negative by PLA has a less than 1% chance of being melanoma compared to around 17% for the morphology based current care pathway). However, no test (neither the PLA nor alternatives are perfect) and patients are strongly encouraged to see their clinicians for concerns or changing lesions.

It is important to talk to your healthcare provider about your test results.

Performance is based on published data from multiple clinical studies.

The risks related to using the Pigmented Lesions Assay are low, with no serious adverse events reported among people in a clinical trial.

Please talk to your healthcare provider to see if the Pigmented Lesion Assay is right for you.  This product is available by prescription only.

Pigmented Lesion Assay® melanoma detection test is a registered trademark of DermTech, Inc.

For complete information on the Pigmented Lesion Assay, please click here.