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Multi-Biomarker Tests Dominated 2013 FDA Clearances

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In last year’s edition of our report, Commercial Trends for Biomarker-Based IVD Tests, we predicted growth in multiplex biomarker tests, and we can now report that tests cleared during 2013 support this prediction.

Over half of all biomarker-based tests cleared by 510(k) during 2013 measure more than one target, and the average number of targets measured was 4. There were also a significant number of tests cleared that measure large numbers of targets, as 13% of cleared tests measure 10 or more targets.