Less invasive alternative to colonoscopy set for 2011 clinical trial
December 16th, 2009 by Jennifer Walker-Journey
A Madison, Wis., company is developing a less invasive way of screening for colon cancer that it hopes will take the place of uncomfortable colonoscopies and increase the number of people willing to be screened for colorectal cancers. Exact Sciences Corp., has developed a DNA-based test that can detect colorectal cancer through a stool sample. Even more convenient than a colonoscopy for the patient, the test can be administered at home and sent to a lab for analysis.
The new test can detect more than 50 percent of pre-cancers and 85 percent of cancers, compared to 85 and 90 percent of cancers with a colonoscopy, says Kevin Conroy with Exact Sciences Corp. There is no day-long prep required, as with colonoscopy procedures, and the cost of the test is far less expensive – $300 to $400 compared to $2,500 for a colonoscopy.
The new test is expected to undergo clinical trials in 2011 and be submitted for FDA approval in 2012. While Exact Sciences isn’t the only company working to develop more patient-friendly screenings for colorectal cancers, it is the only one that focuses on stool-based DNA testing for cancers of the colon and rectum.
“We’re taking it through an FDA clinical trial and then we intend to commercialize it broadly throughout the U.S., and then eventually globally,” Conroy said.
Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States, with more than 106,000 new cases of colon cancer and 40,000 new cases of rectal cancer reported in 2009, according to the American Cancer Society. Regular colon screenings are recommended for people beginning at age 50 and earlier for people with a family history of colorectal cancer or who are experiencing symptoms such as blood in the stool.