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