1. In Vivo

Diagnostics In 2014: More Of The Same

In many ways, the year in diagnostics can be characterized as “more of the same.” The biggest newsmaker was FDA’s finally taking steps toward establishing an oversight framework for the regulation of laboratory-developed tests.

The long-time biases held by investors in potentially high-value diagnostics persist: that companies don’t have all that much pricing power; and those that succeed in technology development often balk – certainly early on – at investing in the kinds of studies that would prove the technology should be practice-changing. Little happened to alter that view during the year.

If anything, the biggest newsmaker in 2014 heightened concerns over the business model. The US Food and Drug Administration finally took steps toward establishing an oversight framework for the regulation...

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