Now backed by Roche, can Foundation Medicine continue to innovate in the delivery of molecular information in oncology and outpace the twin threats posed by the commoditization and regulation of genomic data?

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.

Concerns over patents, the anticipated regulatory oversight over complex tests, and reimbursement and evidence development characterized the continued upheaval in the diagnostics industry over the past year. However, genomics tools and technologies continue to be refined and introduced commercially, and companies with a sharp marketplace focus are showing they can still rise to the top.