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Scientific evidence
Appropriate statistical methods to assess cross-study diagnostic 23-gene expression profile test performance for cutaneous melanocytic neoplasms
Aug 2024
MyPath Melanoma has been well studied over the past nine years in various independent and company-sponsored studies. This publication re-analyzes data from multiple previous performance studies of MyPath Melanoma using a rigorous, standardized method for statistical analysis across studies. Goldberg et al. use a mathematical bootstrapping technique to correct for small, imbalanced, and inconsistent cohort sizes across studies allowing for direct comparison between all studies. The resulting analysis not only found consistently high sensitivity, specificity, positive predictive value, and negative predictive value, but also found no statistically significant difference in performance across both independent and company-sponsored studies.
Publication: American Journal of Dermatopathology
Diagnostic discordance among histopathological reviewers of melanocytic lesions
May 2024
The management of patient with melanocytic lesions is dependent on the diagnosis with guidelines defining treatment protocols for benign nevi and malignant melanomas. Even though diagnostic discordance and diagnostic ambiguity have been previously established, the real-world impact on patient management is not well understood.Using an exhaustive review process by multiple dermatopathologists and a simulated patient treatment model, this study reveals that diagnostic discordance and ambiguity may be more common that previously reported and identifies significant variation in patient treatment in these lesions.
Publication: Journal of Cutaneous Pathology
A clinical impact study of dermatologists' use of diagnostic gene expression profile testing to guide patient management
Apr 2024
Diagnostic GEP tests help guide clinical decision-making in a variety of diagnostically ambiguous or clinicopathologically discordant scenarios.
Publication: Future Medicine
23-gene expression profile (GEP) testing for diagnosis of cutaneous melanocytic lesions in a Medicare-eligible population
Mar 2024
The high accuracy and clinical utility of the 23-GEP test demonstrated across multiple prior studies are applicable to the Medicare-eligible population.
Publication: Poster, presented at the 2023 College of American Pathologist (CAP) Annual Meeting
Diagnostic discordance among histopathological reviewers for difficult-to- diagnose melanocytic lesions
Jan 2024
Publication: Poster, presented at the 2024 Winter Clinical Dermatology Conference - Hawaii®, Honolulu, Hawaii, January 12-17, 2024
Diagnostic utility of the 23-gene expression profile test for an atypical intradermal melanocytic proliferation
Dec 2023
A case report describing how MyPath GEP testing leads to diagnostic clarity in a histopathologically ambiguous melanocytic lesion on the face of a 34-year-old man.
Publication: Future Medicine
A physician’s guide to the use of gene expression profile ancillary diagnostic testing for cutaneous melanocytic neoplasms
Dec 2023
A real-world assessment of common use scenarios of MyPath GEP testing by dermatopathologists and dermatologists to achieve definitive diagnoses and personalized patient management plans.
Publication: Journal of Clinical and Aesthetic Dermatology
Performance of the 23-gene expression profile (23-GEP) test by histopathological evaluation in an independent, multi-center performance cohort of cutaneous melanocytic neoplasms
Nov 2023
Accuracy data in an independent, multi-center cohort of 2512 melanocytic lesions
Publication: Skin
Performance of the 23-gene expression profile (23-GEP) test by histopathological evaluation in an independent, multi center performance cohort of cutaneous melanocytic neoplasms
Oct 2023
Publication: Poster, presented at the 2023 ASDP Annual Meeting
Multi-colored lesion with uncertain malignant potential
Jun 2023
Conflicting clinical and histopathological findings are resolved with the use of GEP test results.
Irregular papule with atypical histopathological findings and borderline/uncertain diagnosis
Jun 2023
Definitive diagnosis cannot be reached in an irregular, raised papule on the dorsal foot.
Atypical melanocytic proliferation on sensitive preauricular check
Jun 2023
Histopathological assessment of a melanocytic lesion on the check could not definitively rule out melanoma leading to the use of GEP prior to determining surgical management.