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Volume IX No. 9 - June 24, 2002

Specialty Lab’s Woes Trigger Big Market Shift

Commentary and Opinion by R. Lewis Dark / By

IT’S THE UNPUBLICIZED STORY BEHIND THE STORY. Most of the laboratory industry knows that Specialty Laboratories, Inc. is the target of sanctions issued by both federal and state laboratory regulators. But the impact of this development has yet to be recognized across the industry. Published federal statutes and regulations do not clearly address Specialty Lab’s …

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Specialty Labs Struggles To Maintain Operations

Laboratory Compliance / By

CEO SUMMARY: In April, Specialty Laboratories, Inc. disclosed that state and federal regulators had placed sanctions on the esoteric testing company, including revocation of its CLIA-88 license, subject to legal appeal. One main source of concern is the fact that, over the past 10 weeks, a sizeable number of Specialty Labs’ customers have begun redirecting …

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Marketing Approved Kits Against “Home Brews”

Pathology Trends / By

CEO SUMMARY: In past years, it was customary for laboratories to shift away from performing or ordering “home brew” tests in favor of FDA-approved test kits as they became available. However, new marketing models for diagnostic testing are shifting this long-standing practice. HIV resistance testing is one type of testing where this battle between “home …

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Employers Ready To Push Hospitals, Docs On Quality

Laboratory Management / By

FOR THE SECOND TIME THIS YEAR, an influential group of large employers has publicly declared its intent to push hospitals and physicians to do more to improve the cost and quality of healthcare. On June 10, the Midwest Business Group declared that it was time for companies to “crack down on medical costs through the …

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Military Labs Creating Global Lab Test Data Pool With LOINC

Laboratory Information Systems / By

CEO SUMMARY: It’s a laboratory regionalization project without precedent because of its worldwide scale. Within the Armed Forces, laboratorians are working to seamlessly integrate laboratory test data generated by laboratories within the Army, Navy, Air Force, and Veterans Administration. LOINC is the tool used to link participating laboratories. The eventual goal is to create a …

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Hospitalwide ISO-9002 Status Stimulates Gains In Laboratory

Laboratory Management / By

AFTER 181-bed St. Charles Medical Center became one of a handful of hospitals in the United States to earn its certification as an ISO-9000 facility three years ago, interaction between nursing and the laboratory has improved in unexpected ways. Located in the central Oregon community of Bend, 181-bed St. Charles is one of less than …

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Myriad Genetics, LabCorp, Abbott Labs, OraSure,TheraSense

Clinical Laboratory / By

DIRECT-TO-CONSUMER ADS FROM MYRIAD GENETICS TO START THIS FALL FOLLOWING THE EXAMPLE of the pharmaceutical industry in using direct-to consumer advertising to build drug sales, Myriad Genetics, Inc. is about to launch an advertising campaign for its predictive genetics tests. Beginning this fall, consumers in Denver and Atlanta will see a television, print, and radio …

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“June 24, 2002 Intelligence: Late Breaking Lab News”

Late Breaking Lab News / By

Competition for HPV testing just got more intense with the announcement that Roche Diagnostics has obtained rights to the Human Papillomavirus (HPV) patent portfolio owned by Institut Pasteur in France. It intends to develop an HPV test that would compete with Digene Corporation’s HPV test. Digene currently holds a strong market position because it owns …

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