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Onconome Announces Results Of Blood Test For Colorectal Cancer; Further Trials Underway
Date:9/14/2012

REDMOND, Wash., Sept 14, 2012 /PRNewswire/ -- Onconome, Inc. today reported the results of studies on 431 patients based upon the blood test it has developed to determine an individual's probability of having colorectal cancer (CRC). The results of the studies have been published in the September issue of the "American Journal of Cancer Research" and demonstrate that Onconome's test is highly sensitive (93.75%) and specific (82.89%) to CRC and has a Negative Predictive Value of 99.9775% (NPV), meaning that a negative test result indicates an extremely low probability of a given patient having CRC. Onconome also reported that two additional clinical trials are now underway at three independent sites to further validate the test's efficacy as a CRC pre-screening tool.

The first of these trials (ONC04) is designed to evaluate blood samples from subjects who are 50 to 80 years old and therefore considered to be at elevated risk of CRC and who are scheduled for colonoscopy. Their samples will then be compared to their colonoscopy results to validate the test's sensitivity, specificity and NPV. The second trial (ONC05) includes patients who have already been diagnosed with CRC or pre-cancerous adenomas via colonoscopy or sigmoidoscopy and are scheduled for surgery. The endpoint of this trial is to establish the test's efficacy in detecting dangerous pre-cancerous conditions in the colon. Both trials are expected to be completed in 2013.

"It's an established fact that nearly half of adults age 50 or older have not had a colonoscopy in the past ten years and that relatively few use fecal occult blood test home kits," said Ray Cairncross, chief executive officer of Onconome. "A simple blood test which addresses these low compliance rates and provides both patients and their clinicians with an accurate assessment of an individual's risk of CRC would be an important tool in deciding whether to have a colonoscopy or sigmoidoscopy."

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