Exiqon said this week that it has presented data showing its blood plasma-based microRNA PCR test for the early detection of colorectal cancer can achieve 82 percent sensitivity for detection of the cancer at 89 percent specificity.
Additional validation studies are expected to wrap up by year end, with data available for publication by the end of the first quarter of 2012. Exiqon added that it will begin a “large prospective validation study based on several thousands of individuals” early next year.
The new data are based on 156 blood samples from five hospitals, Exiqon said. The test requires 100 microliters of plasma collected under standard clinical conditions, and can be completed in a few hours, it added.
“This represents a great breakthrough for Exiqon,” President and CEO Lars Kongsbak said in a statement. “We have developed our proprietary MiRcury LNA Universal RT microRNA PCR system for ... miRNA profiling of blood samples, and we can now demonstrate how this platform may be used to address a large unmet diagnostic need. The technology and procedures may be applied not only for early detection of colorectal cancer, but also for other diagnostic applications in the field of oncology and beyond.”
Earlier this year, Exiqon said that the colorectal cancer test could reach the market by 2014, but this timeline depends on the company finding a partner (GSN 3/10/2011).