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27 Nov 2012

Report reveals fall in biomarker approval volumes

Amplion Research's latest report looks at approval trends for biomarker-based IVD tests in the US.

There has been a decline in the number of approvals of new biomarker-based in vitro diagnostic (IVD) tests, according to a new report by Amplion Research.

The research firm's latest publication, entitled 'Approval Trends for Biomarker-Based IVD Tests: Realizing the Promise of Personalized Medicine', reveals that annual approvals have fallen over the last five years, despite widespread interest in biomarker-based testing.

Amplion Research gives a number of contributing factors for the trend, such as the lengthy and ever-growing FDA review periods for these tests.

In addition, the validation process for biomarkers for commercial use is long and costly, while some tests are not reviewed by the FDA as they are marketed as services.

John Audette, president of Amplion Research, observed: "The FDA has difficult and often competing mandates in maintaining public safety while facilitating advancements in healthcare.

"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 personalised medicine."

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