Diagnostics In 2016: From Alere To Zika

By the end of 2016, the US Food and Drug Administration’s long march toward issuing a Final Guidance on the regulation of laboratory-developed tests had stalled yet again, as a new Congress and a de-regulation focused administration prepare to take office. (Also see "FDA Puts Lab-Developed Test Oversight Plans On Hold" - Medtech Insight, 18 November, 2016.) Also, the comment period around a Draft Guidance on the use of next-generation sequencing (NGS) for diagnosing heritable diseases ended in October. (Also see "Industry: Next-Gen Sequencing Draft Guidances Have Good Ideas But Need Tweaks" - Medtech Insight, 17 October, 2016.) Whether these regulatory actions, aimed at providing clarity to industry, will see the light of day under the Trump administration is anyone’s guess, especially as a potential hiring freeze at FDA could derail efforts to bulk up staff needed to make informed judgments about the introduction and classification of new technologies.

The outgoing US Congress did approve, and President Obama signed, the 21st Century Cures Act and extended the reach of the Cancer Moonshot Program. The Cures legislation includes $1.4 billion...