The diagnostics industry grew an estimated 7% from 2000 to 2001, to more than $20 million, with 8% projected for this year, according to Boston Biomedical Consultants. While in some industries, that figure might be considered lackluster, in diagnostics it is far better than the norm, especially considering that the growth was solid and broad, benefiting most top companies in many product categories.

Roche Diagnostics is the best performing asset at Roche. As the troubled Swiss pharma company suffers through its worst pipeline drought in a decade, Roche Diagnostics is delivering a stellar performance. It is strong across all business segments, from laboratory systems to diabetes to molecular testing. Its challenge: to pull far enough ahead in its traditional businesses to maintain a comfortable lead. Its bigger hurdle, however, is to position itself as a leader in adoption of new genomic and proteomic diagnostic technologies, which is where the industry's future growth lies.

After concerns from the medtech industry that a 2017 final rule requires sponsors with knowledge of off-label use of their product to add it to their label, the US FDA is proposing to delete the confusing text.