"Approval Trends for Biomarker-Based IVD Tests: Realizing the Promise of Personalized Medicine," a new report published by Amplion Research (Nov. 2012; 21 pages; free download) analyzes annual trends for FDA approvals since 2008 with some interesting findings.
Despite the significant buzz around biomarker-based testing, annual approvals of new biomarker-based IVD tests have actually declined over the last 5 years. On the positive side, there has been recent growth in approvals of tests incorporating novel biomarkers. The report can be downloaded at: http://www.biomarkerbase.com/reports.html.
The report does not propose a single explanation for the overall decline in approvals, but several contributing factors are identified, with FDA review periods among them. For biomarker-based IVD tests, the average FDA review period has increased significantly and consistently since the beginning of 2008. Other factors identified in the report include the large costs and long timelines necessary to validate biomarkers for commercial use, and the growth of tests that are marketed as services and thus typically not reviewed by FDA.
"The FDA has difficult and often competing mandates in maintaining public safety while facilitating advancements in healthcare," said John Audette, president of Amplion Research. "Without further analysis it is impossible to say conclusively what role FDA review periods are having on biomarker-based test approval rates, but ensuring that FDA has adequate resources may indeed be a key factor in advancing personalized medicine."
The positive trend identified in the report, the growth in tests utilizing novel biomarkers, is certainly encouraging to proponents of personalized medicine, and if this trend is sustained it could eventually have a much bigger effect on healthcare advancements over time. Recent years have seen new companion diagnostic tests for important cancer therapies, and it is hoped that the boom in the discovery of new biomarkers will increase the number of biomarkers that find their way to the clinic.
"Clinical biomarkers are the central drivers of personalized medicine," said Audette. "Clinical biomarkers facilitate new molecular diagnostic tests, and molecular diagnostics facilitate personalized medicine."