| Summary: | The objective of this report was to systematically review the available evidence on the association of a positive factor V Leiden (FVL) or prothrombin gene (PG) test with a first, unprovoked venous thromboembolism (VTE) (suspected thrombophilia), and the risks and benefits resulting from test use. The report focused on patients presenting with a first episode of unprovoked VTE. The cost implications of FVL and PG testing in Canada were also assessed. The following research questions were addressed: 1. What is the clinical validity of factor V Leiden and prothrombin mutation tests in patients presenting with a first episode of unprovoked (i.e., idiopathic) VTE? 2. What is the clinical utility of testing for factor V Leiden and prothrombin mutations compared to no testing of patients presenting with a first episode of unprovoked (i.e., idiopathic) VTE? 3. What is the cost-effectiveness of testing for factor V Leiden and prothrombin mutation compared to no testing of patients presenting with a first episode of unprovoked (i.e., idiopathic) VTE?
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