查看更多>>摘要：Derails & Qiagen Takes Itself Out of Play As 2O19 came to a close, the biggest story in DX deal making was the pair of anticipated M&A deals that suddenly seem unlikely to happen. As a result, two major genetic testing companies will apparently continue as stand-alones in the coming year, one because it wants to and the other because it has to.
查看更多>>摘要：For Myriad Genetics, Foundation Medicine and other manufactureps of next-generation sequencing (NGS)-based test panels for early tage cancer risk assessment, the recent announcement of CMS fecision to provide limited Medicare coverage for gemline breast and ovarian cancer looks like positive new But while a lot better than the previous version, the propose National Coverage Determination (NCD) is much less than even the half a loaf it looks like.
查看更多>>摘要：Conspicuous by its absence from the list is the proposed $1.2 billion Illumina takeover of Pacific Biosciences whigh suddenly seems to be in major trouble. (See DX Deals on page x for the details). Here are the 1O-highest value M&A diagnostics deals that did come off in 2O19.
查看更多>>摘要：Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA's enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2O19 after issuing just one such warning letter in all of 2O18.
NSTL