# A Molecular Diagnostic Assay for Accurately Differentiating Melanoma from Benign Lesions

> **NIH NIH R44** · FRONTIER DIAGNOSTICS, LLC · 2020 · $944,492

## Abstract

Abstract.
Melanoma is the third most common form of skin cancer with estimated 87,110 new cases diagnosed in the
United States in the year 2017. Current routine diagnostic approaches utilize microscopic evaluation of thinly
sectioned patient biopsies, but in certain cases diagnosis can be contentious even among experts. The overall
goal of this multi-phase SBIR project is to develop, validate, and commercialize MelanoMap™, Frontier
Diagnostics' patented assay for the diagnosis of melanoma using a matrix-assisted laser desorption/ionization
imaging mass spectrometry (MALDI IMS) platform—and to have this assay available to pathologists in the U.S.
as a laboratory developed test. MALDI IMS is a state-of-the-art technology that generates molecular images of
tens to thousands of biomolecules from tissue sections in a single analysis. The assay uses formalin-fixed
paraffin embedded (FFPE) biopsies used in routine histopathological diagnosis. The proposed assay has
pathologists select regions of skin biopsies for analysis via a remote web interface. The acquired IMS data
from those regions unambiguously identifies malignant melanoma or benign nevus.
 Phase I of this proposal will demonstrate the feasibility of this technology platform to achieve cost-effective
diagnosis of melanoma from patient skin biopsies at sample volumes acceptable for a clinical laboratory.
Specific Aim 1 focuses on the development of a scalable and robust analytical protocol in both sample
preparation and informatics to accurately diagnose melanoma with MALDI IMS. In specific aim 2, we will test
the methodology developed in Specific Aim 1 on a cohort of melanocytic lesions with known clinical outcome
and subsequently validate the classification accuracy of the proposed test
 In Phase II, the protocols developed in Phase I will be integrated into a diagnostic service workflow. This
phase will focus on quality control measures, client facing cloud software, clinical diagnostic reporting, and
completing the analysis of a 500-patient sample set for final assay validation. Specific Aim 3 of this proposal
(initial aim of Phase II) will establish and implement test tissues into standard workflows that will provide
performance metrics for standard operation of a test meeting Clinical Laboratory Improvement Amendments
(CLIA) standards. Protocols will be developed to monitor reagents, the reproducibility of sample preparation,
and mass spectrometer performance on daily basis. Specific Aim 4 will expand software capabilities to include
a secure web interface for clients ordering the test and the laboratory performing the test. The software will
meet regulatory compliance, perform statistical analysis, and generate and communicate reports of the MALDI
IMS analysis. Specific Aim 5 proposes to expand the sample set used in the initial assay from Specific Aim 2 to
include a set of 300 patient samples from our clinical collaborators with 5 or more years follow-up data. The
test will be independe...

## Key facts

- **NIH application ID:** 9926849
- **Project number:** 5R44CA228897-03
- **Recipient organization:** FRONTIER DIAGNOSTICS, LLC
- **Principal Investigator:** DAVID L HACHEY
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $944,492
- **Award type:** 5
- **Project period:** 2018-08-01 → 2021-12-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9926849

## Citation

> US National Institutes of Health, RePORTER application 9926849, A Molecular Diagnostic Assay for Accurately Differentiating Melanoma from Benign Lesions (5R44CA228897-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/9926849. Licensed CC0.

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