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Medical Technology  R & D  Story
BioServe, Phenomenome develop cancer diagnostic test

Singapore, August 7, 2007:  BioServe and Phenomenome Discoveries (PDI) 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. Colorectal cancer comprises a tenth of the global cancer burden, and is the third most common malignancy in the world.
 
The new colorectal cancer diagnostic test is currently available in Canada and Japan. The test is also 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 underway.
 
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 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 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 averaged 75 percent, and the specificity averaged 90 percent.  Trials are planned for late 2007 in Canada and Japan, in which healthcare authorities will evaluate the test’s utility as part of a broad-based population screening regimen.
 
Mr John Hyshka, Chief Operating Officer of PDI, said, “Early detection is the single most important factor in improving patient survival. The availability of a simple, serum-based, pre-colonoscopy screening test for CRC will have a positive impact on the low compliance rate of colonoscopy as a screening tool and enable healthcare providers to make more efficient use of the colonoscopy in the management of CRC.”
 
Mr Kevin Krenitsky, Chief Executive Officer, BioServe said, “The development of this new and novel diagnostic test for colorectal cancer showcases how BioServe successfully collaborates with partners to gain insights to disease at the deep molecular level to advance the science of personalized and predictive medicine.”

© BioSpectrum Bureau
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