“February 23, 2004 Intelligence: Late Breaking Lab News”

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There’s a new player offering clinical diagnostic services in oncology. Genomic Health, Inc., based in Redwood City, California, is now accepting specimens. Last month, its laboratory received all the regulatory clearances required to conduct business. The company’s proprietary technology is incorporated in a test it calls Oncotype DX™ . This clinically-validated diagnostic assay provides a quantitative assessment of the likelihood of distant breast cancer recurrence. The test analyzes RNA using a technique called real-time RT-PCR.

There’s consolidation activity among the group purchasing organizations (GPOs). Healthcare Purchasing Partners International (HPPI) of Irving, Texas agreed to purchase the group purchasing assets of Healthcare Services of New England, based in Quincy, Massachusetts. HPPI is owned by VHA and University HealthSystem Consortium, which also jointly own Novation.

C-REACTIVE PROTEIN MAY HAVE VALUE IN COLON CANCER TESTING

High levels of C-reactive Protein (CRP) are considered a sign of increased risk of heart attacks. Now comes a new study that says elevated levels of CRP in blood may also be an early warning sign of colon cancer. Researchers at Johns Hopkins Medical Institute in Baltimore, Maryland studied 22,887 adults. They determined that those with the highest levels of CRP were twice as likely to develop colon cancer as those with the lowest levels of CRP. This was true even when other risk factors, such as family history, age, smoking, and being overweight were considered. The records examined were mostly white adults in Washington County, Maryland, who were participating in another clinical study.

ADD TO: Colon Cancer

In the study, 131 people were diagnosed with colon cancer. Fifty of those diagnosed had CRP levels in the highest range while 20 of the diagnosed patients had CRP in the lowest range. Researchers noted that more study is needed before CRP might be used to improve current screening methods. It is unclear whether high CRP levels result from early colon cancer or represent a risk factor for later development of cancer. For laboratory directors and pathologists, the results of this new study demonstrate how the still-nascent field of proteomics may generate new markers for either early detection of cancer or increased risk of cancer.

P.S. ON PROTEOMICS:

Protein chip developer Ciphergen Biosystems, Inc. announced that long-time lab industry executive Gail Page has joined the company. She is President of its newly-formed Protein Molecular Diagnostics division. Page held executive positions at Luminex Corporation, Laboratory Corporation of America, and Roche Bio- Medical Laboratories. Ciphergen, based in Fremont, California, is developing diagnostic tests which use multiple markers.

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