Sensitivity averaged 75%, and specificity averaged 90%.

BioServe and Phenomenome Discoveries (PDI) have developed a serum-based diagnostic test for the identification of colorectal cancer (CRC) and precancerous states conducive to the development of CRC.

This test is currently available in Canada and Japan. Both companies anticipate that it will be available for distribution in the U.S. in Q4 2007. The test is also currently available for use by researchers worldwide as a fee-for-service research tool that allows research-use-only applications. Further plans for broad commercialization to physicians and patients are under way.

In developing the test, BioServe identified a large number of patient tissue and serum samples from its Global Repository® exhibiting CRC across a spectrum of stages as well as matched healthy controls. Using its patented nontargeted metabolomics platform, PDI discovered that a series of novel metabolites were significantly decreased in serum samples collected from colorectal cancer patients compared to controls.

From these results, PDI developed a two-minute high-throughput screening method capable of simultaneously measuring a key subset of these molecules. BioServe provided a second independent population of 189 CRC samples and 287 controls, and the rapid test was found to be 78% sensitive and 90% specific, the companies report.

The test has now been validated in four independent studies, across which the sensitivity of detection for colorectal cancer positive cases averaged 75% and the specificity averaged 90%, the firms add. Trials, in which healthcare authorities will evaluate the test’s utility as part of a broad-based population screening regimen, are planned for late 2007 in Canada and Japan.

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