August 6, 2007 – BioServe and Phenomenome Discoveries Inc. announced that they have developed a novel serum-based diagnostic test for the identification of colorectal cancer (CRC), and pre-cancerous states conducive to the development of CRC, which is currently available in Canada and Japan, as the companies' plan to position the product for entery into the U.S. market in Q4 2007.
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 PDI’s patented non-targeted 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 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 percent sensitive and 90 percent specific in this validation sample set.
The test has now been validated in four independent studies, across which the sensitivity of detection for colorectal cancer positive cases reportedly averaged 75 percent, and the specificity was said to average 90 percent.