This report evaluates the clinical validity and clinical utility of the Cologuard test (Exact Sciences Corp.).
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.
ThyroSeq v3 Genomic Classifier (University of Pittsburgh Medical Center and Sonic Healthcare USA)
This report evaluates the clinical validity and clinical utility of the ThyroSeq v3 Genomic Classifier (University of Pittsburgh Medical Center and Sonic Healthcare USA).
Signatera (Natera Inc.)
This report evaluates the clinical validity and clinical utility of the Signatera test.
Prostate Health Index (Beckman Coulter Inc.) for Prebiopsy Triage
This report evaluates the analytical validity, clinical validity, and clinical utility of the Prostate Health Index (phi) (Beckman Coulter Inc.).
PancraGEN (Interpace Diagnostics)
This report evaluates the analytical validity, clinical validity, and clinical utility of the PancraGEN (Interpace Diagnostics) test.
Karius Test (Karius Inc.) to Diagnose Infections in Immunocompromised or Vulnerable Hospitalized Patients
This report evaluates the analytical validity, clinical validity, and clinical utility of the Karius Test (Karius Inc.) to diagnose infections in immunocompromised or vulnerable hospitalized patients.
DCISionRT (Prelude Corp.)
This report evaluates the analytical validity, clinical validity, and clinical utility of the DCISionRT (Prelude Corp.) test.
clonoSEQ (Adaptive Biotechnologies)
This report evaluates the analytical validity, clinical validity, and clinical utility of the clonoSEQ test (Adaptive Biotechnologies) specific to U.S. Food and Drug Administration (FDA)-cleared intended use.
MI Profile (Caris Life Sciences) for the Intended Use as a Broad Molecular Profiling Tool
This report evaluates the clinical utility of the MI Profile test for the intended use as a broad molecular profiling tool.
FoundationOne CDx (Foundation Medicine Inc.) for the Intended Use as a Broad Molecular Profiling Tool
This report evaluates the clinical utility of the FoundationOne CDx test for the intended use as a broad molecular profiling tool.