2013: The Year In Diagnostics
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.
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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.
Genetic testing firm 23andMe has stopped providing its genetic tests to consumers, following a warning letter from FDA. The agency has reached a $1.25 million settlement with Johnson & Johnson’s Advanced Sterilization Products group. HHS agencies announced delay in health IT meaningful use implementation. More news.
The agency tells direct-to-consumer genetic testing company 23andMe in a strongly-worded warning letter that it should immediately stop marketing its Personal Genome Service until it can gain clearance. The firm says it will address the agency’s concerns.