Diagnostics In 2016: From Alere To Zika

No significant trends emerged in diagnostics M&A or financing this past year, which did see the introduction of several government-funded initiatives, elements of which will bolster diagnostics innovation. As in other sectors of health care, the biggest question is how the incoming Trump administration could change US regulatory and funding policies.

IV1701_DX-Trends_1200x675

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 Also, the comment period around a Draft Guidance on the use of next-generation sequencing (NGS) for diagnosing heritable diseases ended in October.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...

More from Innovation

More from In Vivo

Rising Leaders 2025: Doxie Jordan, From UNC Graduate To Global Market Strategist

 
• By 

Bristol Myers Squibb executive Doxie Jordan discusses his path to global commercial leadership and the principles guiding pharmaceutical market strategy

Podcast: Brain+ CEO Discusses “Groundbreaking” Potential Of CST Assistant For Dementia Patients

 

Devika Wood, CEO of Brain+, explains the importance of developing health tech solutions for dementia and the growing need to both raise awareness and improve overall access to nondrug interventions like CST.

Behind The Buyout: Dispatches From The Dealmaking Table

 
• By 

In a challenging funding environment for biopharma, strategic dealmaking has become a critical growth engine. In Vivo explores what it truly takes to navigate high-stakes acquisitions and partnerships, drawing on insights from seasoned industry leaders.