Molecular Test Assessments

Molecular Test Assessments are comprehensive health technology assessments of molecular tests across a range of conditions and applications. Each report provides a clear, objective view of the science behind a specific molecular test, the clinical evidence supporting the test, the manufacturer, an explanation of how the test is used in clinical practice, and appropriate patient selection criteria.

These reports include the Hayes Rating to indicate the overall strength and direction of the body of evidence for the molecular test. Molecular Test Assessments provide evidence-based support for the development of coverage policy, utilization management, and evidence-based clinical practices. Reports are reviewed annually up to 5 years post publication to determine if there is new literature or evidence that would impact a change in rating and warrant an updated report.

PrismRA (Scipher Medicine)

This report evaluates the analytical validity, clinical validity, and clinical utility of the PrismRA test. According to the laboratory, the PrismRA molecular signature test identifies which patients with rheumatoid arthritis (RA) are unlikely to respond to tumor necrosis factor-ɑ inhibitor (TNFi) therapies to help guide …

DecisionDx-Melanoma

This report evaluates the analytical validity, clinical validity, and clinical utility of the DecisionDx-Melanoma test.

AlloSure Kidney (CareDx Inc.)

This report evaluates the AlloSure Kidney test for acute and chronic kidney transplant rejection (antibody-mediated and/or T-cell mediated) in patients for either surveillance or for-cause evaluation.

Nodify XL2 (Biodesix Inc.)

This report evaluates the analytical validity, clinical validity, and clinical utility of the Nodify XL2 test.

Nodify CDT (Biodesix Inc.)

This report evaluates the analytical validity, clinical validity, and clinical utility of the Nodify CDT test.

Prospera (Natera Inc.)

This report evaluates the analytical validity, clinical validity, and clinical utility of the Prospera test.