Diagnostic Testing & Technology Report
September 2008
FDA Clears Pathwork Diagnostics Tumor Origin Test
The United States Food and Drug Administration (FDA) has cleared the Pathwork Tissue of Origin test for use in determining the origin of certain tumors, Pathwork Diagnostics (Sunnyvale, Calif.) announced on July 31. The molecular diagnostics company will sell the test to clinical laboratories as an in vitro diagnostic (IVD) kit, as well as continue to offer it as a service through Pathwork’s CLIA-certified laboratory.
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September 2008 - Table of Contents
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