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RECENT WORK

From Diagnostics Intelligence, March 2007:

"Officials with the U.S. Food & Drug Administration (FDA) certainly got an earful February 8 in a packed hotel ballroom. The event was a public forum on the agency's draft guidance about "in vitro diagnostic multivariate index assays," or IVDMIAs. Some 30 people, mostly representatives of molecular testing companies and industry groups, addressed the FDA panel, while another 350 sat in rapt attention. A few of the comments were supportive of the draft guidance, but most were critical -- some subtle, others verging on hostile. In short, most private diagnostic labs speaking up at the meeting are extremely unhappy with the prospect of FDA regulating their activities.

"How the FDA's new approach to regulation plays out could have a huge impact on the introduction of many new genetic and proteomic tests, and even the continued availability of some tests now offered to patients. As some companies have already found out, it can mean lengthy delays and investor pullouts on the road to market.

"At issue is a draft guidance document issued in September, in which FDA revealed plans to require premarket approval for certain types of diagnostic tests. These would include some "home-brew" molecular tests and others that previously were not subject to FDA oversight at all.

"Needless to say, many labs and test developers saw numerous red flags in the guidance, and they made sure the FDA panel members at the February meeting knew it...."