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.

CANCERPLEX (KEW Inc.)

This report evaluates the analytical validity, clinical validity, and clinical utility of the CANCERPLEX test. According to the laboratory, the test is intended to identify patients who are most likely to respond to immune checkpoint inhibition and detect the presence of human papilloma virus (HPV)/Epstein-Barr virus (EBV) viral integration, which may impact treatment decisio…

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4Kscore Test (OPKO Health Inc.)

This report focuses on the analytical validity, clinical validity, and clinical utility of the 4Kscore Test to aid in prostate cancer biopsy decision making for physician and patient through: (1) estimating a patient’s percentage of risk for aggressive (Gleason ≥ 7) prostate cancer if a prostate biopsy were performed; and (2) providing information on the 10-year likelihood of…

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