FDA lengthens review periods for IVD tests that utilize molecular biomarkers

FDA review periods are lengthening for IVD tests that utilize molecular biomarkers, and at a faster rate than for IVDs overall, one of the key findings in a new report published this month by Amplion Research.

“Among the variables that influence review period length, the one with the biggest impact is the selection of the FDA committee conducting the review.”

"Approval and Market Trends for Biomarker-Based IVD Tests (2003-2012)," is a new research report that draws on detailed analyses of every IVD test cleared or approved by the FDA over the last decade. The report can be found at http://www.amplion.com.

While the last decade has seen a boom in the discovery of new molecular biomarkers, the progression of those molecules into new diagnostic tests has been slow. Many factors impact this rate, and one key factor is the FDA review period for tests that enter the market as packaged tests.

"Our analysis uncovered significant variability in review periods, but the overall lengthening trend is clear," said Adam Carroll, Ph.D., Science Director at Amplion Research. "Among the variables that influence review period length, the one with the biggest impact is the selection of the FDA committee conducting the review." Review periods by committee are broken down in the report, as are other factors that could influence review periods, such as the number of targets in a test, and the number of predicate devices cited for a 510(k) test.

Along with the detailed review period analyses, the new report also includes an analysis of the markets for biomarker-based IVDs, including the overall market size, detailed breakdowns of the companies participating, and all mergers and acquisitions among companies that developed biomarker-based IVD tests over the last decade. Geographic breakdowns are also included for all key market data.

Also included in the report is an analysis of the kinds of molecules that are being utilized in new IVD tests, with a special emphasis on the release rates and paths to market for novel molecular targets.

"The report serves users in a variety of roles," said John Audette, Business Director at Amplion Research. "Executives and directors in regulatory, product development, and marketing roles at diagnostics and therapeutics companies will clearly get significant value from this report. But so will professionals involved in technology transfer fields, as well as equity analysts that cover companies in the diagnostics industry."

The heads of NIH and FDA jointly described new diagnostic tests as the keys to advancing personalized medicine. Because this report analyzes release rates for the most advanced new diagnostic tests, it provides direct measurement of progress in implementing personalized medicine. Analysts and policy makers interested in personalized medicine's progress will get essential insights from this report.