No. MelaPro Dx is considered a laboratory developed test, as defined by the FDA, and is regulated by CMS under CLIA.
Yes. 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. MelaPro Dx is validated for seven (7) melanoma subtypes (acral lentiginous, desmoplastic, lentigo maligna, nevoid, nodular, Spitzoid, and superficial spreading), three (3) benign nevus subtypes (acral, conventional, and Spitz), and metastatic melanoma.
MelaPro Dx has not been validated for non-cutaneous neoplasms, non-melanocytic neoplasms, re-excision specimens, specimens directly exposed to radiation therapy, or specimens from patients currently, or recently, receiving chemotherapy.
All benign clinical validation 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 clinical validation specimens required at least two (2) dermatopathologists to concur on a histopathological diagnosis of malignant melanoma.
For each patient specimen, a hematoxylin and eosin (H&E) stained slide is evaluated by an experienced, board certified dermatopathologist. The dermatopathologist annotates areas of the melanocytic skin lesion that will be targeted by the mass spectrometer. On average, approximately 20 distinct annotation locations are targeted per patient specimen.
The patient specimen must meet the following requirements. If these requirements are not met, the specimen may be rejected, the test result may be incorrect, and/or the test result may be delayed. The patient specimen must be a cutaneous melanocytic lesion that contains sufficient melanocytic cells for testing. The specimen must be formalin fixed paraffin embedded (FFPE) tissue. The patient specimen may either consist of three (3), 5-micron thick FFPE serial sections or one (1) FFPE block. If submitting serial sections, the middle serial section must be mounted on the plus slide, and each end serial section must be adhered to the etched side of a New River Labs slide. No extra paraffin may be added to the slides.