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The following is a review of diagnostics related medical research worldwide

DEAR READER: Ah, Where did the summer go? Hope ya'll had a wonderful, healthy summer and are ready as I am to roll up those sleeves and get back to work. The following are some events that took place from June to August. Welcome back to StratCom's monthly update.

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Research News for Summer 2001

Genzyme General has been conducting a post-marketing study that adds new evidence that Thyrogen (thyrotropin alfa injection) can help doctors identify those at risk of a recurrence of thyroid cancer. Thyrogen was approved by the FDA in late-1998 as an adjunct to two common thyroid cancer screening tools, serum thyroglobulin (Tg) testing and whole body scanning. It increases the sensitivity of the Tg test while also allowing patients to avoid the side effects of hypothyroidism, such as fatigue, depression and weight gain, associated with whole body scanning.
The preliminary results presented today suggest that Thyrogen can be a useful tool in screening patients who have been treated for thyroid cancer but are in the early stages of disease follow-up, when the risk of recurrence is highest.

Zynx Health Inc., a subsidiary of Cedars-Sinai Health System has developed the Prometheus Decision Model, a non-invasive method to diagnose inflammatory bowel disease (IBD). The model uses a panel of serological markers (ANCA, ASCA IgA, ASCA IgG and OmpC) that have been associated with IBD and shows significant promise as a fast and accurate diagnostic complement to traditional invasive diagnostic strategies. For select patients, the diagnostic strategy described in the model has the potential to decrease the number of unnecessary diagnostic procedures (including colonoscopies and radiographs) currently used to differentiate IBD from other abdominal disorders.

Researchers at the Serono Pharmaceutical Research Institute (SPRI) in Geneva have developed a new procedure that should greatly improve the sensitivity of current tests used to detect abnormal prion proteins. These are believed to cause fatal neurodegenerative diseases such as bovine spongiform encephalopathy (BSE) in cattle, scrapie in sheep and Creutzfeldt-Jakob disease (CJD and nvCJD) in humans. The procedure mimics and amplifies the replication of abnormal prion proteins in the body compressing years of real-life time into a few hours in the laboratory and therefore provides a very sensitive test for BSE and other prion diseases. Current tests are not used to detect BSE in dead animals under 30 months of age or those recently infected, and there are no tests available for live animals or humans.

Genaissance Pharmaceuticals, Inc. has announced that the enrollment goal of 600 patients has been achieved for the largest prospective personalized medicine clinical trial ever conducted. The STRENGTH (Statin Response Examined by Genetic HAP Markers) Study is designed to link specific markers of human genetic variation to clinical response so that physicians can decide which cholesterol lowering drug is best for each patient based on their own DNA. A full analysis of the study is expected to be completed in the first quarter of 2002. The four drugs under study are: Lipitor (atorvastatin), Zocor (simvastatin), Pravachol (pravastatin) and Baycol (cerivastatin).

Immunicon Corporation has received a grant from the Department of Health & Human Services (DHSS), National Institutes of Health (NIH)/ National Cancer Institute (NCI) to support the development of a new technology that enumerates circulating cancer cells in peripheral blood from patients with solid tumor cancers.

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