In Vitro Gene Testing Cleared
The FDA granted marketing approval to Affymetrix, Incorporated for the company’s new diagnostic test for in vitro gene expression. Also approved was the Pathwork Tissue of Origin Test, from Pathwork Diagnostics, Incorporated.
The Pathwork system evaluates the gene expression profile of tumors. This information can be used as an adjunct to identify tumors which are difficult to pinpoint.
Extensive clinical testing was completed with the system to support validation, as well as analytic assessment. The system further provides a diagnostic platform to support gene-expression tests developed in the future
The combination of these two systems broadens the array of diagnostics to evaluate hard-to-identify tumors. This is the first time such a system has received clearance from the federal regulatory body.
August 1, 2008 Related topics: Product Approval & Certification, Laboratory, New Technology & Innovation, Laboratory Equipment, Diagnostic, Hematology & Oncology