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Volume XV No. 14 - October 20, 2008

Genome Sequencing Promises to be Disruptive

Commentary and Opinion by R. Lewis Dark / By

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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Rapid Genome Sequencing Predicted by Mid-2009

Genetic Testing / By

CEO SUMMARY: In the same way that the Human Genome Project was disrupted by the entry of C. Craig Venter and Perkin-Elmer in what was then a 15-year, $3 billion project, now Complete Genetics of Mountain View, California, is disrupting the race to the $1,000 human genome sequence. Developments in this field are moving at …

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ICD-10 Conversion Costs Underestimated by HHS

Laboratory Billing / By

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

Molecular Diagnostics / By

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

Laboratory Compliance / By

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

Clinical Laboratory Trends / By

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

Pathology Trends / By

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

Late Breaking Lab News / By

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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