Today, we launched our first clinically validated test, MelaPro Dx™. This test utilizes our proprietary histology guided mass spectrometry (HGMS) profiling technology. MelaPro Dx employs proteomic profiling and machine learning to differentiate between challenging cutaneous melanocytic lesions and classify a lesion as either benign or malignant.
MelaPro Dx is the product of a long-standing collaboration between Dr. Rossitza Lazova, now of California Skin Institute and formerly of Yale University, and myself. This test expands on our earlier work focused on atypical Spitzoid neoplasms. We began applying HGMS technology to melanocytic lesions nearly 10 years ago, and we are proud to see this work transition from a research interest to a clinical test that can help patients exhibiting histopathologically challenging melanocytic lesions.
MelaPro Dx was developed using a training set of 211 cutaneous melanocytic lesions and validated using an independent cohort of 545 cutaneous melanocytic lesions. Test development and validation included seven melnaoma subtypes (e.g., acral lentiginous, desmoplastic, lentigo maligna, nevoid, nodular, Spitzoid, and superficial spreading), three benign nevus subtypes (e.g., acral, conventional, and Spitz), as well as metastatic melanoma. Clinical validation resulted in sensitivity of 98%, specificity of 99%, and overall accuracy of 99%. An indeterminant rate of less than 5% was observed, and these specimens were excluded from the sensitivity and specificity calculations.
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A major advantage of MelaPro Dx over existing melanoma tests is that it evaluates the proteomic, as opposed to genomic, contents of melanocytic cells and does so in a highly targeted manner. We believe that by studying the expressed proteins within the melanocytic cells, we can better understand the disease state and classify a histopathologically ambiguous lesion. This contrasts with genetic expression profiling (GEP), which analyzes the genetic information present in the cells. In order for phenotypic changes to be observed, DNA must be translated into RNA and then transcribed into proteins, so measurement of genes may not provide an accurate representation of the biology. In short, HGMS focuses on expressed proteins that represent the active state of melanocytic cells, whereas GEP simply focuses on the potential for biological change to occur.
MelaPro Dx is now available to physicians throughout the country, although it is not yet currently available in CA, MD, NY, PA, and RI. Physicians can order test kits through our website and submit Test Requisition Forms through our online physician portal.
We look forward to engaging with physicians in the coming months to discuss the benefits of MelaPro Dx, listen to feedback, and answer questions. If you would like to learn more about MelaPro Dx, please email us at email@example.com or call us at (800) 850-5675.