Signature Diagnostics Presents Positive Colorectal Screening Study Results At The 12th World Congress On Gastrointestinal Cancer In Barcelona

Main Category: Colorectal Cancer
Also Included In: GastroIntestinal / Gastroenterology;  Cancer / Oncology
Article Date: 09 Jul 2010 - 2:00 PDT

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Signature Diagnostics announced 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 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.

Source:
Signature Diagnostics AG

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