Signature Diagnostics Announces Positive Study Results Using Predictor C to Predict Disease Progression and Therapeutic Risk in Colorectal Cancer Patients
* 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 international, prospective, multi-center performance
evaluation study showing the diagnostic ability of Predictor C to distinguish
between high-risk and low-risk disease progression. Predictor C, a prognostic
tissue test for UICC stage II / III colorectal cancer, uses Affymetrix
technology to evaluate the expression of 32 genes that are involved in the
disease's progression. 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: 3612).
"Predictor C will have a significant impact on both the diagnosis and treatment
of stage II and III colorectal cancer patients. Our multi-gene test enables
physicians to predict colorectal cancer progression and thereby provide their
patients with a more specific treatment following surgery," said André
Rosenthal, CEO of Signature Diagnostics AG. "The ability of this test to predict
colorectal cancer recurrence and the development of metastases fulfills a large
unmet clinical need."
Predictor C has been successfully validated using an independent set of frozen
tumor tissue from 164 UICC stage II and III colorectal cancer patients. Within
the five-year observation period, 72 patients experienced disease progression
while no progression was seen in 92 patients. The validation study demonstrated
a sensitivity (S+) of 64 percent; a specificity (S-) of 63 percent; a positive
predictive value (PPV) of 58 percent; and a negative predicted value (NPV) of
69 percent.
In particular, the PPV of 58 percent underpins Predictor C's clinical utility
and justifies adjuvant treatment for high-risk patients. Predictor C identifies
51 percent of all stage II / III patients having a high-risk of disease
progression.
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
Colorectal cancer (CRC) is the third most common cancer worldwide. In the five
major European countries and the USA, approximately 400.000 individuals are
diagnosed with CRC every year. Of these, 280.000 patients are diagnosed with
stage II and stage III CRC. Approximately 30 percent of the patients with stage
II and roughly 50 percent of those with stage III experience disease progression
including distant metastasis of the liver and lung or local recurrence within
three to five years after surgery. If the cancer spreads to distant organs, the
five years survival rate is only 8 percent. Presently, there are no validated
clinical parameters or biomarkers in use to identify patients with a high-risk
of disease progression. If this risk could be determined, a substantial number
of patients with stage II / III disease would benefit from adjuvant chemotherapy
in addition to surgery.
For questions, please contact:
Jana Frömke
Corporate Communications
Signature Diagnostics
Hermannswerder 20A
14473 Potsdam, Germany
Tel: +49-331-2000-208
PR@signature-diagnostics.de
[HUG#1421183]
Press release (PDF): http://hugin.info/143237/R/1421183/370514.pdf
