Issue: Volume XV No. 14 - October 20, 2008

Genome Sequencing Promises to be Disruptive

EVERYONE SHOULD CAREFULLY READ OUR LEAD STORY ON THE FACING PAGE. Titled “Rapid Gene Sequencing Predicted by Mid-2009,” it is a revealing look at the declaration of California-based Complete Genetics that, in less than eight months, it will begin delivering full human genome sequences priced at $5,000 each to interested customers at a cost of …

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ICD-10 Conversion Costs Underestimated by HHS

CEO SUMMARY: Criticism of the October 1, 2011 implementation date for ICD-10 is building. Last week, a new study was released that highlights how federal officials underestimated the costs and time required to implement the complex new codes for ICD-10. One large national laboratory company estimates it will spend at least $40 million to prepare …

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Hospital Labs Have New Options for Molecular Dx

CEO SUMMARY: Laboratories that offer molecular assays continue to see strong growth in four areas: oncology, hematopathology, infectious diseases, and personalized medicine. Further, a new generation of molecular testing systems and analyzers is coming to market which will make it easier for even smaller community hospital laboratories to establish and perform molecular tests that are …

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LabCorp’s Ovarian Cancer Test Generates FDA Warning Letter

WHEN THE FOOD AND DRUG ADMINISTRATION (FDA) sent Laboratory Corporation of America a letter in September declaring its marketing of the Ovasure test for ovarian cancer was a violation of the law, the news was widely reported. Because Ovasure is a test that is being marketed as a home brew test, the fact that the …

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Siemens, BioImagene, Clarient University of Pennsylvania, Mayo Clinic

SIEMENS INVESTS IN DIGITAL PATHOLOGY, BUYS STAKE IN BIOIMAGENE IMAGING AND RADIOLOGY GIANT SIEMENS just made an interesting investment in digital pathology systems. On October 16, Siemens Venture Capital (SVC) revealed that it had purchased a stake in BioImagene Inc. (www.bioimagene.com) of Cupertino, California. The amount of the investment was not disclosed. The timing of …

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Pathology Boot Camp to Address Three Trends

CEO SUMMARY: Anatomic pathology groups across the nation must develop effective strategies to address challenges in pricing, intensifying competition, and expensive new technologies. That’s the assertion of three pathology practice administrators who have organized a boot camp in Dallas next month specifically to train other practice administrators and managers. This event will provide administrators from …

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Dark Daily

October 20, 2008 “Intelligence: Late Breaking Lab News”

Once again, laboratory test unbundling is on the radar screen of federal regulators. Included in the 2009 work plan for the federal Office of Inspector General (OIG) is a review of laboratory test unbundling and a review of the extent of variation in laboratory test payment rates among Medicare contractors. OIG will determine if clinical …

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