December 22, 2008 “Intelligence:  Late Breaking Lab News”

Last Thursday, Sunquest Information Systems, Inc. of Tucson, Arizona, announced that it would purchase the “Outreach Advantage Solution” software system developed by Pathology Associates Medical Laborator ies of Spokane, Washington. PAML has spent most of this decade developing a comprehensive, integrated software system designed specifically to give hospital laboratory outreach programs a full service capability to make them competitive with national laboratories. PAML uses the Sunquest LIS, which permitted  Sunquest to participate in supporting the development of Outreach Advantage. PAML has been selling Outreach Advantage to hospitals since 2007.

MORE ON: Sunquest

Outreach Advantage makes it easier for hospital lab outreach programs to establish needed support services. It “provides customer relationship management tools, sales and marketing business intelligence, mobile courier management, and connectivity tools for integrating and interfacing with EMRs, Web, LIS, and other enterprise systems.” Since its acquisition in 2007 by private equity investors, Sunquest has been actively building its product portfolio of solutions for laboratories.

GENENTECH PETITIONS FDA TO REGULATE LDTS

Genentech lobbed a grenade at the clinical laboratory industry earlier this month by submitting a Citizens Petition to the Food and Drug Administration calling for it to regulate predictive “laboratory-developed tests” (LDTs). LDTs are often called home brew tests by the lab industry. Genentech is apparently looking forward to personalized medicine. In its petition, it observes that, were the FDA to assume regulation of these types of in vitro diagnostic tests, this “would allow the FDA to focus its attention on high risk LDTs,” a definition which Genentech described as tests “used in clinical decision making to determine the use of a particular drug or biologic for the treatment of a patient.”

ADD TO: Petition

It didn’t take long for the American Clinical Laboratory Association (ACLA) to respond to this news. Last Friday, ACLA issued a statement, predicting that, if the FDA adopted this position, it “would have a chilling effect on innovation and patient care while stifling the promise of personalized medicine.”

Dark Daily Update

dark_daily_logoHave you caught the latest e-briefings from DARK Daily? If so, then you’d know about…

…management changes at Laboratory Corp. of America on January 1, when Myla Lai-Goldman, M.D., and Brad Smith, retire. This month, Bill Bonello joined LabCorp to manage investor relations.

You can get the free DARK Daily e-briefings by signing up at www.darkdaily.com.

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