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Technology

Through the use of histology guided mass spectrometry profiling and machine learning algorithms, we are able to evaluate the proteomic contents of targeted cells and develop a spectral fingerprint for disease diagnosis and treatment response. Our tests provide actionable intelligence, enabling physicians to develop personalized treatment plans and improve patient outcomes. 

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For Patients

Our tests provide physicians with accurate and objective results that enable physicians to better develop treatment plans for patients. We provide physicians with an improved ability to more accurately diagnose a patient’s condition and predict whether a treatment or surgical procedure will be effective or necessary.

 

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For Providers

Our tests provide actionable intelligence, enabling physicians to develop personalized treatment plans and improve patient care. By targeting patient misdiagnosis, mistreatment, and overtreatment, we seek to help physicians improve patient outcomes and positively impact overall healthcare spending.

 

FAQ

1

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.

2

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.

3

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.