Final Thoughts

Published: January 16, 2013
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Approval Trends for Biomarker-Based IVDs

Approval trends for biomarker-based IVDs are among the best objective measures of progress in advancing personalized medicine.


By: John Audette

The basic promise of personalized medicine is predicated in large part on the expanding availability of biomarker-based testing, and FDA-approved tests offer the broadest market for any biomarker that is to be developed into an IVD. Approval trends for biomarker-based IVDs are thus among the best objective measures of progress in advancing personalized medicine.
A new report that reviews trends in approvals of 510(k) and premarket approved molecular IVDs shows an appreciable decline in the number of tests approved annually since 2008. FDA approved a total of 82 new biomarker-based IVDs in 2008 while just 52 are projected to be approved this year (44 having already been approved by the end of October 2012). The decline also has been relatively steady over the period.
This trend exists even as overall approvals of IVDs have remained consistent over the period, and while the number of new biomarkers described in the literature has grown considerably. The road to clinical utility remains “long and uncertain” for any newly discovered biomarker, and chief among the rate-limiting variables are technical, reimbursement, and regulatory factors.
Many if not most new protein biomarkers are currently discovered on a different platform than the one preferred for clinical use. Mass spectrometry is the preferred discovery platform for protein biomarkers due to its ability to uncover a large number of candidate biomarkers from a single sample, but until that technology appreciates wider clinical use any newly discovered biomarker will almost certainly have to be verified, qualified, and validated using immunoassays. The often limited availability of suitable antibodies, RUO kits and samples are among the technical factors that work against rapid advancement of candidate biomarkers, along with the fundamental challenge of simply reproducing a mass spec discovery with an immunoassay.
Nucleic acid biomarkers face less of a discovery-to-deployment gap, but tests that measure such analytes must still confront the requirement for large-scale clinical studies. In part, this is to satisfy FDA, but the endorsement by medical societies is usually an even more important factor. Without such endorsement, a new IVD has far less chance of being reimbursable.
Regulatory review is also becoming increasingly lengthy and costly for test developers. The average review period for a biomarker-based IVD has increased by almost 100 days since 2008. This delays the ability of the test developer to get the IVD on the market and start earning back the development costs; requests from FDA for additional data or product revisions also add to those costs.
Developers of molecular IVDs are faced with long product development timelines combined with development budgets that increase exponentially as the product matures. These efforts culminate in market opportunities that now face growing competition from LDTs and diminishing opportunities for patent protection. It would not be surprising (but would certainly be distressing) if financial incentives are currently insufficient for all but a small number of novel biomarkers to be moving into IVD development pipelines.
The report referenced in this article can be downloaded free of charge.

John Audette is president of Amplion Research (Bend, OR). He can be reached at


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