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.

FoundationOne CDx (Foundation Medicine Inc.)

According to the testing laboratory, the FoundationOne CDx (F1CDx) is a companion diagnostic test used to identify patients who may benefit from treatment with Food and Drug Administration (FDA)-approved targeted therapies. Additionally, the test is intended to provide tumor mutation profiling that includes the screening of biomarkers without companion diagnostic claims. This…

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AmniSure ROM Test for Detection of Fetal Membrane Rupture

Health Problem: During pregnancy, the fetal membranes contain the developing fetus and amniotic fluid and provide protection from infection. Although the membranes normally rupture during labor, in approximately 10% of pregnancies, rupture occurs before initiation of labor. Premature rupture of membranes (PROM) must be diagnosed accurately an…

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EndoPredict (Myriad Genetics)

Breast cancer is the most common cancer in American women, with 1 in 8 women developing breast cancer during their lifetime in the United States. It is 1 of the most common forms of cancer, representing 14.6% of all new cancer cases in the United States, with an estimated 246,660 new cases of breast cancer diagno…

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