This report evaluates the analytical validity, clinical validity, and clinical utility of the Afirma Genomic Sequencing Classifier (Veracyte Inc.) test.
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.
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…
EndoPredict (Myriad Genetics Laboratories Inc.)
This report evaluates the analytical validity, clinical validity, and clinical utility of the EndoPredict (Myriad Genetics Laboratories Inc.) test.
ChemoFx Assay (Helomics)
This report evaluates the analytical validity, clinical validity, and clinical utility of the ChemoFx test, an in vitro patient tumor–derived cell culture assay that determines how cancer cells may respond to chemotherapeutic agents in order to help guide physicians’ treatment decisions in patients with gynecologic cancer.
Breast Cancer Index (BioTheranostics Inc.) for Lymph Node–Positive (1-3) Patients
This report evaluates the analytical validity, clinical validity, and clinical utility of the Breast Cancer Index test (BioTheranostics Inc.) for lymph node–positive (1-3) patients.
Breast Cancer Index (BioTheranostics Inc.) for Lymph Node–Negative Patients
This report evaluates the analytical validity, clinical validity, and clinical utility of the Breast Cancer Index test (BioTheranostics Inc.) for lymph node–negative patients.
Epi proColon (Epigenomics Inc.)
Focus of the Report: This report evaluates the analytical validity, clinical validity, and clinical utility of the Food and Drug Administration–approved Epi proColon blood-based liquid biopsy test, for the detection of methylated Septin 9 (SEPT9) as cell-free circulating DNA, that is intended to screen for colorectal cancer (CRC) in average-ris…
FirstSightCRC (CellMax Life)
The report evaluates the analytical validity, clinical validity, and clinical utility of the FirstSightCRC test, a liquid biopsy test that detects and analyzes circulating tumor cells (CTCs) and is intended to predict the likelihood of having precancerous adenomatous polyps or colorectal cancer (CRC) in patients eligible for CRC screening.
DecisionDx-UM (Castle Biosciences Inc.)
This report evaluates the analytical validity, clinical validity, and clinical utility of the DecisionDx-UM test.
ColonSentry (Stage Zero Life Sciences)
The report evaluates the analytical validity, clinical validity, and clinical utility of the ColonSentry liquid biopsy test, a gene expression assay intended to estimate the current relative risk of having colorectal cancer (CRC) for patients eligible for CRC screening.