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| [November 26, 2012] |
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Biomarker Approval Volume Down but Novelty Up, Says Amplion Research
BEND, Ore. --(Business Wire)--
"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 peiod 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."
About Amplion Research
Amplion Research is a business intelligence company that fuses science
and business information to develop new research tools for understanding
the markets for discovering, developing, and commercializing molecular
biomarkers. Amplion publishes BiomarkerBase™, The Clinical Biomarker
Database (http://www.biomarkerbase.com),
along with custom and syndicated research reports.
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