Signature Diagnostics Announces Positive Study Results for Detector C, Its Non-Invasive, Blood-Based IVD Screening Test for Early Detection of Colorectal Cancer
(Thomson Reuters ONE) -
* Study data to be presented on June 6 at the Annual American Society of
Clinical Oncology (ASCO)
* Product Launch planned for Q4 2010 - Q1 2011
POTSDAM, Germany, June 4, 2010 - Signature Diagnostics AG announced today
positive results from its prospective, multi-center clinical study validating
Detector C, its in-vitro diagnostic screening product. Detector C is a
non-invasive, blood-based screening test for the early detection of colorectal
cancer. The test uses Affymetrix technology to evaluate the expression of 202
genes that are active in white blood cells in response to tumor formation and
growth. The test showed a consistently high sensitivity of 90 percent for all
four cancer stages (including early stages), and a specificity of 88 percent.
The company will present the complete study data at the American Society of
Clinical Oncology (ASCO) on June 6, between 2:00 - 6:00 PM, in Hall A2 (Abstract
No: 3580).
"Detector C is the safest and most accurate blood-based screening test
available, making it particularly well suited for population screening. The
unprecedented low number of false negatives warrants its use prior to
colonoscopy and as an alternative to inaccurate haemocult II tests," said André
Rosenthal, CEO of Signature Diagnostics AG. "Detector C 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."
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.
Multivariate analysis showed no significant effect in relation to stage, age,
gender, tumor localization, or RNA quality on correct prediction. Detector C
showed an extremely low false negative rate of only one in 872 tested
individuals, which is four times lower than the false negative rates of other
blood-based tests. In comparison to Haemocult II (gFGOBT), Detector C has a
seven times lower rate of false negatives.
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's first products, Predictor C and Detector C, will be launched by
the end of 2010 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 (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:
Jana Frömke
Corporate Communications
Signature Diagnostics
Hermannswerder 20A
14473 Potsdam, Germany
Tel: +49-331-2000-208
PR(at)signature-diagnostics.de
[HUG#1421631]
Press release (PDF): http://hugin.info/143237/R/1421631/370915.pdf
Unternehmensinformation / Kurzprofil:
Datum: 04.06.2010 - 10:09 Uhr
Sprache: Deutsch
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