Trends In Diagnostics – 2012
Diagnostics industry trends include the increasing adoption of genomics in clinical testing and with it a focus on services and workflow more so than differentiated technology; a slowdown in M&A activity, partly to allow the digestion of assets acquired in 2010-11; and the ongoing uncertainties of regulation and reimbursement of high-value molecular tests.
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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.
The current crop of molecular diagnostics acquisitions – espcially those made by nontraditional buyers – must mature prior to the commencement of additional M&A activity. Historical data suggest this could occur starting in the 2014-2015 timeframe.
Recent moves by CMS have left up in the air an innovative program that gives labs a clearer opportunity to demonstrate clinical utility and test value. It’s therefore unclear whether companies and their backers should expect any greater certainty over the ability to command premium prices for high-value diagnostic tests.