Laurel, MD and Saskatoon, SK, Canada – BioServe and Phenomenome Discoveries Inc. (“PDI”) today 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. Colorectal cancer comprises a tenth of the global cancer burden, and is the third most common malignancy in the world. According to the National Cancer Institute, in the United States during 2007 there were an estimated 153,760 new cases of colorectal cancer and 52,180 deaths from the disease.
The new colorectal cancer diagnostic test is currently available in Canada and Japan. Both companies anticipate that the test will be available for distribution in the United States 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 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% sensitive and 90% 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%, and the specificity averaged 90%. 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.
“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,” said John Hyshka, Chief Operating Officer of PDI. “BioServe’s clinical colorectal cancer data and control samples from its vast Global Repository of over 600,000 human DNA, tissue and serum samples were critical to accelerating our research in colon cancer and developing this breakthrough diagnostic test. Based on our success in CRC, we have expanded our collaboration with BioServe to identify serum biomarkers for other forms of cancer as well as multiple sclerosis.”
“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,” said Kevin Krenitsky, Chief Executive Officer, BioServe. “PDI is at the forefront of molecular biomarker research and discovery, and we look forward to the discovery of similar biomarkers in other diseases as a result of our expanded collaboration with PDI and to the development of more ‘wellness’ enhancing diagnostics.”