In a continuing effort to refresh the content of our research report, Commercial Trends for Biomarker-Based IVD Tests, we have begun to look at the companies that had tests cleared by 510(k) or approved by PMA during 2013.
Roche led all companies in total number of tests released during 2013, when combining the output of its Diagnostics division and its subsidiary Ventana Medical Systems.
Thirty companies in all released new tests during 2013, with an average of two tests released per company.
Click image to enlarge. This figure lists the total number of biomarker-based tests that were cleared by 510(k) or approved by PMA during 2013, by the companies that developed them.
Roche clearly remains bullish on IVDs, and its IVD pipeline reflects this confidence.