MAUDE Adverse Event Report: DERMTECH DERMTECH MELANOMA DETECTION; LABORATORY DEVELOPED TEST

Device Problems False Positive Result (1227); Product Quality Problem (1506)

Patient Problems Laceration(s) (1946); Scar Tissue (2060)

Event Date 05/22/2023

Event Type  Injury  

Event Description

Dermtech is marketing an "innovative melanoma detection" test as a laboratory developed test (ldt) indicated for: ¿ detection of linc00518, prame, and tert expression (changes in your skin's rna and dna - genomic testing) ¿ testing is performed on a lesion sample of superficial cells using the dermtech smart sticker to "painlessly life cells from the surface of the skin" ¿ so that melanoma may be caught at its earliest stages ¿ it is not indicated for lesions o <5mm or >19 mm size o on ht epalms, soles of feet, mucous membranes o ulcerated or bleeding lesions o patients under 18 years of age ¿ the trifold marketing flyer indicates "false positives and false negatives may occur" ¿ it is prescription use only and the doctor uses the test result to make clinical decisions such as surgical biopsy if a positive result is found for any of the genomic markers tested for more information about the dermtech genomic test see also dermoscopic features associated with 3-gep pla: linc00518, prame, and tert expression in suspicious pigmented 1.21 u.S.Code § 352 - misbranded drugs and devices this product labeling if false or misleading based on the following: a.There is not enough evidence to support linc00518, prame, and tert expression as reasonable and medically necessary testing to screen skin cells for melanoma.The testing is not supported by professional practice guidelines (nccn guidelines) as a screening standard.There is also insufficient peer-reviewed literature to support any clinical decision making based on these tests b.These genomic markers have not been clinically validated in surface skin cells lifted from lesions c.The test is not reasonable or medically necessary nor clinically proven to be safe and effective screening for melanoma d.Enforcement discretion for ldts is premised on tests that have low risk of harm to patients e.The fda has not reviewed the test in a risk/benefit paradigm associated with clinical sensitivity (the ability of a test to correctly identify patients with a disease) or specificity (the ability of a test to correctly identify people without the disease).F.This test result is triaging to biopsy without evidence that the risks of an unnecessary biopsy (pain, wound healing, scarring, patient reported satisfaction, etc.) outweigh the potential benefit of genomic screening not supported as a standard for melanoma screening 2.False claims act (fca), 31 u.S.C.§§ 3729 dermtech is causing false claims submissions to federal and private insurance companies for skin biopsies performed for positive results from a test that is not reasonable or medically necessary.A.Billing the dermtech genomic test to federal and private insurance is fraud given the test a.Has a risk of unnecessary biopsy not reviewed by fda in the context of safety and effectiveness of the test for the intended use "melanoma detection" b.Is not supported as standard for melanoma screening c.Genomic markers are not supported in professional practice guidelines or peer-reviewed literature as standards for melanoma screening d.Is misbranded and falsely labeled b.Billing lesion biopsies to federal and private insurance is fraud when the clinical decision to biopsy a lesion is based on the results of dermtech genomic test that a.Reports genomic test results that have insufficient evidence of correlative value in melanoma screening b.Reports a genomic test result on a sample type (skin cells) that has not been clinically validated appropriate for genomic testing otherwise performed on tissue biopsy samples c.Has not been demonstrated safe and effective in the clinical evaluation of skin lesions to triage suspicious lesions to biopsy i had an unnecessary biopsy as a result of a ldt false positive result.I presented to (b)(6).Using a dermatoscope and the non-contact technique my clinical pa evaluated a sunspot on my right lower extremity and suggest a "sticker test".I agreed to the sticker test but after the fact regretted the decision based on my literature review of the test and it's underwhelming predictive value.I received a phone call from (b)(6) informing me that my sticker test was "prame positive" suggesting i should have a biopsy.On date subsequent to this phone message, i engaged my clinician in a conversation about the questionable validity of the sticker test.I asked for some local practice statistics that the clinician could not report to me.Specifically, while i realize a negative sticker test "rules out" melanoma, i wanted to know how often a sticker test is falsely positive.I asked to know how many sticker positive cases at the practice were actually confirmed to be melanoma and how many positive sticker tests were biopsy negative.I suggested the test is a driver for unnecessary biopsy procedures and indicated that even i was now "obligated" to a biopsy just by the reason of suggested "risk" that ultimately is not a test result with any predictive value for melanoma.My biopsy was benign.The wound from my unnecessary biopsy is healing and likely to scar over time.Marketed as an ldt with a risk profile that is more than low to moderate risk associated with false test results including using the test result to triage to biopsy.

• Brand Name: DERMTECH MELANOMA DETECTION
• Type of Device: LABORATORY DEVELOPED TEST
• Manufacturer (Section D): DERMTECH
• MDR Report Key: 17080401
• MDR Text Key: 316810419
• Report Number: MW5118236
• Device Sequence Number: 1
• Product Code: OQS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White