MelaPro Dx can only be ordered by a licensed physician or an appropriate healthcare professional. The test is currently available throughout the US, with the exception of California, Maryland, New York, Pennsylvania, and Rhode Island.
Within approximately five (5) business days of test kit receipt, MelaPro Dx testing will be completed, a score will be generated to classify the patient specimen, and the test result will be made available to the physician through the New River Labs online physician portal.
No. MelaPro Dx is considered a laboratory developed test, as defined by the FDA, and is regulated by CMS under CLIA. New River Labs, LLC meets the requirements under CLIA to perform high complexity clinical laboratory testing.
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.
Histology guided mass spectrometry profiling is performed on the patient specimen. The molecular profile of the patient specimen is assigned a score based on a validated algorithm. The assigned score classifies a patient specimen as likely benign, indeterminant, or malignant.
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.
MelaPro Dx was developed as an ancillary test to augment histopathological evaluations, aiding in the accurate diagnosis of melanocytic skin lesions when histopathology alone is insufficient. 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 and more definitive diagnosis.
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.
MelaPro Dx is a new test. Currently, New River Labs accepts all insurance plans. When a New River Labs test is ordered, the physician provides us with the necessary insurance and billing information so that we can work on the patient’s behalf to seek payment coverage from the relevant insurance plan. We will seek pre-authorization approval from, and submit claims to, the insurance provider.
Patient care is our top priority, and we endeavor to make our ancillary diagnostic and prognostic tests available to all patients. If you have questions or need assistance, please contact us at firstname.lastname@example.org.
Yes. New River Labs, LLC meets the requirements under CLIA to perform high complexity clinical laboratory testing.
No. New River Labs, LLC intends to apply for CAP accreditation in 2019.
A physician, or appropriate healthcare professional, may order a New River Labs test kit for each patient’s tissue specimen. Test kits can be ordered through the company’s website, and test kit orders are usually processed the same day and received by the physician’s requested date.
When a physician, or appropriate healthcare professional, orders a test kit for the first time, we will email the physician with login credentials for the New River Labs online physician portal. Portal account access enables the physician to order tests and view test results. The physician may order a test by filling out and submitting a Test Requisition Form through the online physician portal. Please email email@example.com if you require assistance setting up or accessing a new portal account.
The ordering physician will be notified when test results are available. The physician will then be able to view test results via the New River Labs online physician portal.