Diagnostics In 2015: Past Trends Coalesce, New Roads Open

The introduction of Apple’s ResearchKit is our top story of the year. Mobile apps and the increasing ability to take measurements of vital signs, gather information on habits and collect other phenotypic measures is rapidly changing thinking about clinical trials design.

Many of the fundamental trends and issues we’ve spotted in the past several years – the degree of leverage the diagnostics industry can gain from the integration of companion diagnostics into pharma’s development planning, the regulation of laboratory-developed tests, and the infiltration of next-generation genome sequencing on just about every level of drug/diagnostics development, for example – coalecsed in 2015, much as they had started to do last year when we titled our year-in-review piece “More of the Same.” (See Also see "Diagnostics In 2014: More Of The Same" - In Vivo, 21 January, 2015..) This past year may be thought of as one of acceptance, or consolidation of thought. These matters are now well-trod turf. But much new territory was also claimed during the year, most notably in the areas of digital health, data acquisition and analytics.

Call it the ascendance of the app, and no story carries more weight than the introduction of Apple’s ResearchKit, announced...

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