MelaPro

Dx
The first objective proteomic test to differentiate between malignant melanomas and benign nevi
99%
Accuracy
98%
Sensitivity
99%
Specificity
MelaPro Dx Graphic 2

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Overview

What is MelaPro Dx? 

Each year in the United States, over four million skin biopsies are collected due to suspicion of melanoma.1,2 Up to 14% of these cases are classified as ambiguous based on histopathological evaluation, and even for samples receiving a diagnosis, a high degree of diagnostic variability, uncertainty, and discordance can be observed even among experienced dermatopathologists.3,4,5 MelaPro Dx was developed as an ancillary test to histopathological examination, providing physicians with actionable intelligence when histopathology alone is insufficient for accurate diagnosis of melanocytic lesions.

MelaPro Dx applies histology guided mass spectrometry (HGMS) profiling to evaluate the proteomic contents of melanocytic skin lesions in order to distinguish malignant melanomas from benign nevi.6,7 In contrast to other available tests that simply evaluate the genetic potential for malignancy, MelaPro Dx assesses the proteomic content of a melanocytic lesion and develops a molecular snapshot of the active state of targeted cells. MelaPro Dx proteomic data are statistically analyzed with a clinically validated algorithm to yield a numerical score that classifies lesions as likely benign, indeterminant, or malignant.

Clinical Validation

MelaPro Dx is a clinically validated test for melanocytic skin lesions. The test objectively differentiates between malignant melanomas and benign nevi with a sensitivity of 98% and a specificity of 99%. Clinical validation was performed with 545 cutaneous melanocytic lesion specimens, encompassing seven (7) melanoma subtypes, three (3) benign nevus subtypes, as well as metastatic melanoma. All benign specimens received a definitive clinical diagnosis with a minimum of five (5) years of patient clinical follow up information to confirm the clinical outcome. Malignant specimens required at least two (2) dermatopathologists to concur on a histopathological diagnosis of malignant melanoma. 

Resources:

melapro-clinical-validation_11.28.18

Test Process

Objective, more accurate, less specimen material, faster results

1

Order Test Kit

New River Labs will provide a test kit for each patient’s tissue specimen. Physicians can order test kits online, and test kit orders are usually processed the same day and received by the physician’s requested date.

2

Test Requisition

The MelaPro Dx test can be ordered by submitting the Test Requisition Form through the New River Labs online physician portal. Alternatively, a paper Test Requisition Form may be filled out and submitted with the test kit.

3

Test Kit Submission 

After following the Test Kit Instructions, the physician will send the completed test kit, including three (3) serial tissue sections or one (1) tissue block, to New River Labs for analysis at its clinical reference laboratory.

4

Analysis

Within approximately five (5) business days of test kit receipt, MelaPro Dx testing will be completed and a score will be generated that classifies the specimen as likely benign, indeterminant, or malignant.

5

Results

MelaPro Dx results will be made available to the physician through the New River Labs online physician portal.

Results

Clear Outcomes

MelaPro Dx proteomic data are statistically analyzed with a clinically validated algorithm to yield a numerical score, ranging from -10 to +10, that classifies melanocytic lesions as likely benign, indeterminant, or malignant. Results are reported to the physician via the New River Labs online physician portal. Physicians can easily review and interpret the MelaPro Dx results and, in conjunction with histopathological data, clinical examinations, and other relevant findings, render a final diagnosis.

View Test Result Sample

MelaPro Dx Result Scale - Benign