FAQ

Who can order the test?

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.

MelaPro Dx is new, and physicians may not yet be aware of the test. For more information about MelaPro Dx, physicians are invited to email us at info@newriverlabs.com or call us at (800) 850-5675.

How soon are the test results available?

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.

Is the test FDA approved?

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.

Is the test clinically validated?

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.

What is the diagnostic standard against which the test was clinically validated?

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.

How should the test results be interpreted?

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.

  • Benign: Scores ranging from -10.000 to -0.371
  • Indeterminant: Scores ranging from -0.370 to +0.370
  • Malignant: Scores ranging from +0.371 to +10.000
How is the test area of the targeted melanocytic lesion identified?

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.

How should the test results be used in the diagnosis of melanocytic lesions?

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.

What are the patient specimen requirements?

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.

How is the test paid for?

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 billing@newriverlabs.com.

Does New River Labs comply with CLIA?

Yes. New River Labs, LLC meets the requirements under CLIA to perform high complexity clinical laboratory testing.

Is New River Labs a CAP accredited laboratory?

No. New River Labs, LLC intends to apply for CAP accreditation in 2019.

How do I order a New River Labs test kit?

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.

How do I order a New River Labs test?

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 help@newriverlabs.com if you require assistance setting up or accessing a new portal account.

How do I view the results of a New River Labs test?

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.