JOHN HORNBERGER 1, MD, AND DARRELL RIGEL 2, MD, STANFORD UNIVERSITY 1, STANFORD, CA AND NEW YORK UNIVERSITY MEDICAL CENTER 2, NEW YORK, NY 

HEALTH ECONOMIC IMPLICATIONS OF A  NONINVASIVE GENE 
EXPRESSION TEST FOR PRIMARY CUTANEOUS MELANOMA 

INTRODUCTION
The majority (>90%) of about 2.5 million surgical biopsies performed in the 
US to rule out melanoma are benign and categorized as neither invasive 
melanomas nor melanomas in situ by histopathology. A recently described 
adhesive patch skin biopsy based non-invasive gene expression test 
(pigmented lesion assay, PLA) demonstrated utility and differentiated 
benign from malignant pigmented skin lesions with a test performance that 
exceeded visual inspection (VI) and a sensitivity that matching the gold 
standard of dermatopathology. 1-4 However, cost and outcome implications 
of using this molecular test versus VI have not been evaluated.

RESULTS
A biopsy ratio reduction from 12.5 for VI to 2.4 for PLA use was observed. 
The number needed to excise (NNE) declined from 2.85 for VI to 1.37 for 
PLA use. The 1.77-fold increase in specificity of PLA over VI also resulted in 
lower costs for initial biopsy ($211), subsequent excisions ($86), surveillance 
management ($77), and management of melanoma ($508). There was $31 
average savings from avoidance of lost work productivity, and improvement 
in patient experience as assessed by quality adjusted life years (gain of 
0.016 years).  Figure 1 depicts the decision diagram.

CONCLUSION
The improved accuracy of PLA use versus VI led to fewer unnecessary 
procedures and office visits, without negative impact on the early detection 
of melanoma. This results in potentially reduced direct medical costs, 
reduced loss of work productivity and improved patient care and experience. 

REFERENCES
Gerami et al., Development and validation of a non-invasive 2-gene molecular 

assay for cutaneous melanoma; JAAD-D-16-00647R1, 2016.

Ferris et al., Utility of a noninvasive 2-gene molecular assay for cutaneous 

melanoma and effect on the decision to biopsy. JAMA Dermatology, 

153(7)675-680, 2107.

Yao et al., Analytical characteristics of a noninvasive gene expression assay for 

pigmented skin lesions. ASSAY and Drug Development Technologies, 

14(6)355-363, 2016.

Yao et al., An adhesive patch-based skin biopsy device for molecular diagnostics 

and skin microbiome studies. Journal of Drugs in Dermatology, 16(10)611-618, 2017.

STUDY AIM, DESIGN AND METHODS 
We set out to determine potential cost savings and impact on outcome of 
PLA use versus VI in patients with pigmented cutaneous lesions suggestive of 
melanoma. 
We performed health economic analyses from average US insurance 
reimbursement values comparing the real-world impact the PLA may have 
with VI. Data sources were from published clinical validation and utility 
studies as well as from routine use of the test in US dermatology practices, 
augmented by fee schedules of CMS. 

Patients with
suspicious lesion

Melanoma

“Supicious”

“Non-suspicious”

No melanoma

“Supicious”

“Non-suspicious”

Bx

Bx

“Positive”

“Negative”

Excision

“Positive”

“Negative”

Excision

“Malignant”

“Malignant”

“Benign”

“Benign”

“Benign”

“Benign”

“Benign”

“Benign”

“Atypia”

Figure 1. Decision DiagramSupported by DermTech, Inc.

1.

2.

3.

4.


	FC17PosterDermTechHornbergerHealthEconomicImplications.pdf