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.

Cologuard (Exact Sciences Corp.)

Focus of the Report: This report examines the analytical validity, clinical validity, and clinical utility of the Cologuard stool DNA test for the qualitative detection of colorectal neoplasia‚Äďassociated DNA markers and for the presence of occult hemoglobin in human stool, which may indicate the presence of colorectal cancer (CRC) or advanced a…

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VeriStrat for Prognostic Use in Patients with Advanced NSCLC (Biodesix Inc.)

The report evaluates the analytical validity, clinical validity, and clinical utility of the VeriStrat test, a liquid biopsy-based proteomic test that identifies a chronic inflammatory immune response indicative of aggressive disease in patients with advanced non-small cell lung cancer (NSCLC) and is intended to provide prognostic information to assist physicians with patient…

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