Contact Information: Contacts: Kevin Krenitsky Chief Executive Officer BioServe 301-470-3362 Alix Hayden Director, Business Development Phenomenome Discoveries Inc. 306-244-8233 Constantine Theodoropulos Boston Communications 617-619-9801
BioServe and Phenomenome Discoveries Develop Novel Diagnostic Test for Colorectal Cancer
| Source: BioServe
LAUREL, MD and SASKATOON, SK--(Marketwire - August 6, 2007) - 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."
About Phenomenome Discoveries Inc.
Phenomenome Discoveries Inc. (PDI) is a privately owned company located in
Saskatoon, Saskatchewan, Canada. Using its patented non-targeted small
molecule biomarker discovery and development platform, PDI conducts human
health research focused on the biochemical characterization of disease and
restoration of metabolic balance. Key areas of focus include cancer and
mental health research. PDI offers contract biomarker discovery solutions
and personalized metabolic health monitoring. www.phenomenome.com.
About BioServe
BioServe is a leader in the processing, development, and validation of
diagnostic tests for the practice of personalized, predictive and
preventive medicine. Leading pharma, biotech and diagnostic firms
collaborate with BioServe to identify and validate markers that cause
disease while correlating clinical and molecular data to develop new
diagnostic tests promoting wellness around the world. BioServe offers the
Global Repository®, a growing library of over 600,000 human DNA,
tissue and serum samples linked to detailed clinical and demographic data
from 140,000 consented and anonymized patients from four continents.
Leveraging BioServe's robust genomic analytical services, technology,
Global Repository and CLIA-certified laboratory, collaborators gain a
complete, highly efficient platform for processing diagnostic test results
and identifying genomic markers for powerful new assays. BioServe has
headquarters in Laurel, MD and Hyderabad, India. For more information
please visit www.bioserve.com or call 301-470-3362.
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