POTSDAM, GERMANY--(Marketwire - April 06, 2011) - Signature Diagnostics /
Signature Diagnostics to Present a novel Companion Diagnostic Product
Response to Cetuximab in Colorectal Cancer at the 102nd AACR Meeting in
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Potsdam, Germany, April 6, 2011 - Signature Diagnostics AG announced today
the company was selected to present its novel companion
predicting response to Cetuximab in patients with colorectal cancer (CRC)
stages at the 102nd Annual Meeting of the American Association for
Research (AACR) in Orlando on April 2-6, 2011.
The paper, "BRAF and PIK3CA mutations in addition to KRAS improve
resistance to Cetuximab in a large panel of colon carcinoma
presented at the late breaking poster session on April 5, 8:00am-12:00am.
This innovative proprietary companion diagnostic (CDx-Cetuximab)
detection of the mutation status of PIK3CA and BRAF in addition to KRAS
accurate prediction of response to Cetuximab, an approved anti-EGFR
patients with CRC of all four stages, especially in UICC stage II and
Wild-type PIK3CA, BRAF and KRAS predicts response to Cetuximab
sensitivity of 83% and a specificity of 76%. By addition of the KRAS
35G > A mutation to wild-type PIK3CA, BRAF, and KRAS the CD-Cetuximab
response to Cetuximab with an increased sensitivity of 94%.
"Today, the KRAS mutation status is the only companion diagnostics
predicting response to Cetuximab and Panitumumab in patients with
metastatic colorectal cancer. Both drugs are not approved for treating
with colorectal cancer of UICC stage II and III. Our novel companion
CD-Cetuximab comprises the mutation status of three genes, PIK3CA,
KRAS, and is highly accurate in predicting response to Cetuximab in
with CRC of UICC stage II and III" said Prof. André Rosenthal, CEO of
Diagnostics. "The development of companion diagnostics that predict
Cetuximab in CRC patients of UICC stage II and III, opens the way for
pivotal trials, that may lead to label extension of anti-EGFR antibodies
adjuvant setting of CRC."
About Signature Diagnostics AG
Signature Diagnostics AG is a molecular diagnostics company based in
Germany, focusing on the development and commercialization of novel
oncology diagnostic products for early detection (screening) and
cancer. The company has completed development of its first two
products for colorectal cancer screening ("Detector C/C+") and
("Predictor C"), which will be launched in 2011 in its own ISO 15189
service laboratory. Using its state-of-the-art technologies in tissue and
sample collection, molecular pathology, Xenopatient™ platform,
profiling, data mining, and biostatistics, the company collaborates
clinical, pharmaceutical, and diagnostic partners. Signature
sponsors and conducts large prospective, multicenter clinical trials with
than 33 primary care hospitals and several dozen colonoscopy centers in
to discover and validate biomarkers in oncology.
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Hermannswerder 20 A Potsdam Germany
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