Signature Diagnostics to Present Company's Newest Product in Colorectal Cancer Screening at the 35th ESMO Congress in Milan
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Signature Diagnostics /
Signature Diagnostics to Present Company's Newest Product in Colorectal Cancer
Screening at the 35th ESMO Congress in Milan
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* Blood-based screening test, Detector C/Plus, uses a panel of 1,802 RNA
markers for increased sensitivity and specificity
Potsdam, Germany, October 8, 2010 - Signature Diagnostics announced today that
Andre Rosenthal, CEO, will present the company's newest developments in
colorectal cancer (CRC) screening at the Biomarker Session of the 35(th)
European Society for Medical Oncology (ESMO) Congress in Milan on October
11, 2010. The abstract, entitled "An RNA Gene Signature for Screening of
Colorectal Cancer from Whole Blood with High Sensitivity and a Specificity Close
to that of Colonoscopy," describes Signature Diagnostics' newest product,
Detector C/Plus, which was shown in a multi-center study to further increase the
sensitivity and specificity of CRC screening.
Through the use of 1,802 RNA markers, Detector C/Plus has achieved even greater
specificity for blood-based CRC screening. Using blood samples from a multi-
center clinical study, Signature Diagnostics prospectively validated Detector
C/Plus and achieved overall sensitivity S+ of 87 percent (95 percent CI:
81.8-91.4 percent). The validated specificity S- is 92.5 percent (95 percent CI:
86.6 percent-96.3 percent).
Detector C/Plus is a variant of Signature Diagnostics' Detector C product. To
increase its health economic impact, Detector C/Plus has been further optimized
to achieve a validated high specificity of 92.5 percent.
"The test runs on the Affymetrix GenChip platform and could be priced comparable
to Detector C," André Rosenthal added. "The test's low false positive rate of
7.5 percent is close to that of colonoscopy and ensures that endoscopy resources
in certain major markets will not be exhausted by large-scale use of this blood-
based test."
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 early detection (screening) and prognosis 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 Detector C in early 2011 in its own ISO 15189
certified service lab.
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. Only 360,000 CRC cases (7 percent) are currently
diagnosed annually (EU-5: 220,000, USA: 140,000). Classical screening methods,
including haemocult II (gFOBT) and colonoscopy, detect only 5 percent of these
360,000 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 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 non-invasive, blood-based tests that
can detect individuals with early stage CRC with high accuracy 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#1450277]
--- End of Message ---
Signature Diagnostics
Hermannswerder 20 A Potsdam Germany
Press release (PDF):
http://hugin.info/143237/R/1450277/391760.pdf
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Unternehmensinformation / Kurzprofil:
Datum: 08.10.2010 - 16:03 Uhr
Sprache: Deutsch
News-ID 44764
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contact information:
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