Regulating molecular diagnostic assays: developing a new regulatory structure for a new technology

Abstract

Molecular diagnostics are playing an increasingly important part in the practice of medicine. However, molecular diagnostics have not yet made the clinical impact that many had predicted. Multiple factors affect the uptake and utilization of molecular diagnostics, including government regulation. Current regulatory systems were not developed to optimize regulation of molecular diagnostics. This article recommends areas that should be carefully evaluated and appropriately revised, including risk assessment, review criteria and facilitating product improvements. The adoption of molecular diagnostics will be advanced as regulatory criteria become more predictable and their application becomes more consistent between products and over time.

Keywords::

• diagnostic regulation
• FDA
• Food and Drug Administration
• in vitro diagnostics
• molecular diagnostics
• personalized medicine
• regulatory framework

Financial & competing interests disclosure

Jeffrey N Gibbs and his law firm provide legal and consulting services to companies that manufacture, distribute and provide in vitro diagnostic tests. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.