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Bringing the Ovarian Cancer Test to Market

An ovarian cancer assay based on protein pattern analysis is arousing excitement in a field all too often met with disappointment. Given initial excitement over the test and protein pattern analysis in general, business activity is likely to follow shortly. The NCI, FDA and a start-up, Correlogic Systems, are developing the test and taking it to large clinical trials this summer. Correlogic claims to have broad patents on pattern analysis for diagnostic purposes, a contention that is sure to lead to controversy, given the apparently high stakes.

The use of protein pattern arrays to detect early-stage cancer is one of the most intriguing recent advances in cancer diagnostics. In preliminary clinical studies, a series of tests aimed at early detection of a variety of cancers seem to demonstrate the approach's high specificity and sensitivity. Arousing particular excitement in a field all too often met with disappointment and false promises is an ovarian cancer assay, whose results were published in the February issue of The Lancet. A study of roughly 100 high-risk women found the test picked up normally undetectable early-stage ovarian cancer in 100% of patients. (See "Overcoming Skepticism in Cancer Diagnostics," START-UP, May 2002 Also see "Overcoming Skepticism About Cancer Diagnostics" - Medtech Insight, 1 May, 2002..)

Given the compelling clinical aspects, business activity certainly won't be far behind. If protein patterns turn out to have as...

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