The Balkanized State Of Molecular Diagnostics Reimbursement
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.
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Systems Biology Goes Commercial As Integrated Diagnostics Launches Lung Nodule Test
With the launch of its Xpresys Lung test, Integrated Diagnostics joins the ranks of commercial molecular diagnostics companies offering tests to help physicians characterize suspicious tissue. But unlike other tests on the market and in development, the Xpresys Lung test is designed to be used early in the process – before a biopsy is even ordered.
Device Trends To Watch In 2013
The prospective medical device tax, the continuing decline of venture investing, pricing challenges, austerity measures in Europe, and other headwinds continued to push against the medtech industry in 2012. But emerging clinical and geographic markets, along with an active M&A market, are providing the industry with some momentum going into 2013.
Veracyte: How To Build A Molecular Cytology Company
Veracyte has launched a complex molecular diagnostic test in thyroid in record time and with impressive capital efficiency. It could be a model for high-value diagnostics, especially if the company can successfully adopt its approach in a broader market.