Medical Devices Today

AHRQ On Genetic Testing Data

Full brief reprinted from "The Gray Sheet" - June 2, 2008

There are over 1,000 gene-based tests in clinical use, and the global market is expected to reach $12.5 billion in 2009, AHRQ says.

FDA Genetic Test Oversight Is On The Rise, But How Far Can It Go?

It looks increasingly likely that FDA will play a larger role in genetic test oversight, though policymakers may soon have to decide just how much more the agency can and should do.

"There is a major gap in the oversight of genetic tests when it comes to the evaluation of clinical validity. ... A truck can drive through that hole," says Reed V. Tuckson, M.D., chief of medical affairs at UnitedHealth Group and chair of a Department of Health and Human Services advisory panel tasked with drafting a better model for genetic test oversight. "We find that to be unacceptable and it needs to be fixed."

Industry and government agency reps are calling for FDA review of all diagnostic tests, including those developed by laboratories, and their proposals are increasingly attracting attention. Currently FDA does not regulate most lab-developed tests, or LDTs, sold as diagnostic services. The agency consistently regulates in vitro diagnostic test kits, sold as packaged products.

"Body Computing" On The Web: An Interview With Cardiologist Leslie Saxon

This Special Bonus Interview is from the November 5, 2007, issue of "The Gray Sheet"

Leslie Saxon says the next big thing in medicine is "body computing."

As the chief of cardiovascular medicine at the University of Southern California's medical school describes it, body computing relies on devices with sensors that transmit information to the Web to be accessed and acted upon not only by doctors but by patients as well.

Medical devices with remote monitoring capabilities (see ¹previous story), already available from firms including Medtronic, St. Jude Medical, Boston Scientific and MedApps in the cardiac rhythm management and diabetes spaces, will be central, though not sufficient to achieve this model, she says.

Siemens' Model For The Future Unites Imaging And In Vitro Diagnostics

From the July 23, 2007, issue of "The Gray Sheet"

The business opportunity in linking in vitro diagnostics to in vivo imaging studies is generating significant buzz, and Siemens believes it is currently the only firm positioned to drive this health care model.

The imaging systems powerhouse created an in vitro diagnostics subsidiary, Siemens Medical Solutions Diagnostics, in January with the $5.3 billion acquisition of Bayer's diagnostics division. The subsidiary also integrates in vitro firm Diagnostics Product Corp., which Siemens bought in June 2006.

According to Siemens Medical Solutions Diagnostics CEO Tony Bihl, Siemens' imaging and in vitro diagnostic capabilities, coupled with the purchase of information technology company SMS in 2000, sets the firm apart in the diagnostics arena.