Signature Diagnostics Presents Positive Colorectal Screening Study Results at the 12th World Congress on Gastrointestinal Cancer in Barcelona
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* Blood-based test, Detector C, detected 90 percent of colorectal cancer cases
and a substantial proportion of precancerous lesions
* Product launch planned by year-end
POTSDAM, Germany, July 8, 2010 - Signature Diagnostics announced today that on
June 30 2010, company CEO, Andre Rosenthal, opened the scientific session of the
European Society for Medical Oncology (ESMO) Conference: 12th World Congress on
Gastrointestinal Cancer, in Barcelona, Spain, by presenting the positive results
of its colorectal cancer screening test. Detector C, an in-vitro diagnostic
blood-based screening product for the early detection of colorectal cancer, has
been shown to detect 90% of all colorectal cancers as well as a substantial
proportion of precancerous lesions known as high-grade adenomas. Using
Affymetrix technology to evaluate the expression of 202 genes that are active in
response to tumor formation and growth, the test has shown a sensitivity of 90
percent for all four cancer stages (including early stages), and a specificity
of 88 percent.
André Rosenthal, founder and CEO of Signature Diagnostics, cited the test's
significance in fulfilling a large unmet clinical need: "Detector C is the
safest and most accurate blood -based screening test available, making it
particularly well suited for population screening. It has the potential to
provide an early warning to hundreds of thousands of individuals with early
stage colorectal cancer, enabling them to begin treatment while their disease is
still curable."
Given the unprecedented accuracy of its test, Signature Diagnostics plans to
launch Detector C by the end of this year.
About Signature Diagnostics AG
Signature Diagnostics AG is a molecular diagnostics company based in Potsdam,
Germany, focusing on the development and commercialization of novel in-vitro
diagnostic (IVD) products for the prognosis and early detection (screening) of
colorectal cancer. Using its state-of-the-art technologies in tissue and blood
sample collection, molecular pathology, genome-wide tumor profiling
technologies, data mining, and biostatistics, the company collaborates with many
clinical and diagnostic partners. Signature Diagnostics sponsors and conducts
large prospective, multicenter clinical trials with more than 25 primary care
hospitals and several dozen colonoscopy centers in Germany to discover and
validate RNA biomarkers in colorectal cancer and colorectal cancer screening.
The company plans to launch both Predictor C and Detector C, by the end of 2010
in its own ISO 15189 certified service lab.
About Detector C
Detector C has been successfully validated using an independent set of 343 blood
samples including 210 samples originating from patients confirmed with all four
stages of colorectal cancer and 133 samples from healthy controls over age 55
undergoing colonoscopy for screening purposes. The prospective validation study
demonstrated a sensitivity of 0.90 (95% CI: 0.851-0.937) and a specificity of
0.88 (95% CI: 0.812-0.930). The sensitivity results by UICC stage are as
follows: stage I: 0.89 (95% CI: 0.774-0.958), stage II: 0.90 (95% CI:
0.788-0.961), stage III: 0.90 (95% CI: 0.805-0.959), and stage IV: 0.93 (95% CI:
0.765-0.991). Detector C also identified high-grade intraepithelial neoplasia
with a sensitivity of 0.66.
About Colorectal Cancer Screening
The EU-5 and US screening population (aged 50 to 79) totals 170 million
individuals. Approximately 5.1 million individuals (3 percent) have an
undetected colorectal cancer (CRC). Only 396,000 CRC cases (7.8 percent) are
presently diagnosed annually (EU-5: 220,000, USA: 176,000). Classical screening
methods, including haemocult II (gFOBT) and colonoscopy, detect only 5 percent
of these 396,000 CRC patients. In 4.7 million individuals affected with CRC, the
asymptomatic cancer remains undetected.
In Germany, 73,000 patients are diagnosed with CRC every year. Due to the risks
and inconvenience associated with CRC colonoscopy screening (bleeding events,
colon perforations), patient participation is low (3-5 percent per year).
Therefore, CRC screening using colonoscopy results in the diagnosis of only
5.400 patients each year. Furthermore, CRC screening, using gFOBT, is declining
due to the test's inaccuracy and the difficulties associated with collecting
stool samples. There is a great need for a non-invasive in-vitro diagnostic
(IVD) that can detect early stage CRC and serve as a reliable screening tool.
For questions, please contact:
Prof. Dr. André Rosenthal, CEO
Signature Diagnostics
Hermannswerder 20A
14473 Potsdam, Germany
Tel: +49-331-2000-208
PR(at)signature-diagnostics.de
[HUG#1430472]
--- End of Message ---
Signature Diagnostics
Hermannswerder 20 A Potsdam Germany
Press release (PDF): http://hugin.info/143237/R/1430472/377243.pdf
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Unternehmensinformation / Kurzprofil:
Datum: 08.07.2010 - 15:01 Uhr
Sprache: Deutsch
News-ID 23652
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