FDA approves local company's non-invasive test for colon cancer - WKOW 27: Madison, WI Breaking News, Weather and Sports

FDA approves local company's non-invasive test for colon cancer

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MADISON (WKOW)-- A new alternative for one of the most dreaded medical procedures is about to hit the market. Cologuard is the first ever non-invasive colorectal cancer test that can be taken under the privacy of your own home. The product was created by Madison based company Exact Sciences and was approved by the FDA on Monday.

"In the next several months this is a product that's going to be not just available for sale, but covered by Medicare by the end of this year," Chief Operations Officer Maneesh Arora says.

The new innovation took 20-years to develop. Exact Sciences started in Boston, but never fully took off. In 2009, the company re-launched in Madison with only two employees. The company now employs close to 300 people with 200 of those employees working right here in Madison.

Company executives say their product was created in order to give consumers a safe and accurate alternative to the colonoscopy. The American Cancer Society estimates that the screening rate for colon cancer is less than 60%. The ACS has a goal of increasing that rate to 80% by 2018. Executives at Exact Sciences say that's where their new product comes in.

"There are 80 million Americans across this country that are eligible for screening and half of them have never been screened with a colonoscopy. The market opportunity is absolutely tremendous," Arora says.

All of the samples that are collected nationwide will come here to Exact Sciences new laboratory on Badger Road. The facility has enough space to handle close to a million samples annually. With all of these samples comes an increased number of laboratory workers to analyze them.

"We do anticipate continuing to grow with the success of the company here in Madison, here in Dane County," Arora says.

The Cologuard system comes in a small box that is shipped to your home. Customers can request a kit by talking with their physician. The kit contains a small air tight bucket, some liquid solution, a swabbing test kit and a bracket that can attach to your toilet. Once a stool sample is collected, the kit needs to be sealed up and sent through the mail.

The sample is analyzed by technicians using 11 different bio markers that can show whether or not cancer cells are starting to form in your colon. The product currently has a 94% sensitivity to early stages of cancer. Officials say this sensitivity rate is similar to that of the traditional colonoscopy. Colon experts say the new test won't replace the colonoscopy, but is merely a non-invasive alternative that should help out with the low nationwide testing rates.

"Colon cancer screening rates aren't nearly what they should be. That's why I still think we're really trying to improve access and improve technology to make it easier to get more people screened," UW Health Colon Expert Sam Lubner says.

The Centers for Medicare and Medicaid is proposing nationwide coverage of Cologuard. Health officials are trying to make the product more readily available to consumers. Exact Sciences is currently working with insurance providers to get their product covered under their policies.


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MADISON (WKOW) -- The FDA has approved a non-invasive screening test for colorectal cancer made by Madison-based Exact Science. 

The product, called Cologuard, analyzes stool-based DNA (sDNA) and blood.

The company hopes Cologuard helps improve colorectal cancer screening rates. Currently, more than 60% of Americans 50 and over are not getting tested as recommended. Current tests require medication, dietary restrictions or bowel preparation prior to taking the test.


Gordon Severson will look at the potential benefits of the test and how the FDA-approval will impact the local economy tonight in 27 News at 5 and 6.
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