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First Year on the Market; Doctors say Cologuard Offers an Alternative to Skipped Colon Cancer Screenings

Last year we told you about Cologuard, the non-invasive in-home colon cancer screening test.

A year later, is it doing its job?

Dr. Kirk Ludwig, Chief of Colorectal Surgery at Froedtert & the Medical College of Wisconsin Cancer Center Network, said, "I'm not sure I would call it a game changer."

Ludwig says he has not prescribed the test to a single patient, "No I have not. I've talked with patients about it, but we haven't really had anyone that's taken us up on it."

He also said, “There are a number of questions that haven't been completely been answered."

Here's how Cologuard works; a doctor prescribes it, it's sent to your home, you provide a stool sample, and send it through the mail to the lab.

Results are sent to your doctor within two weeks.

Ludwig says there is not enough research showing how effective Cologuard is.

The maker of the product, Madison's Exact Sciences, says Cologuard does have a 13% false positive rate, [a recent study shows that rate could be as low as 7%, which means people then need to have a potentially unneeded colonoscopy.

A company spokesman says Cologuard was never supposed to be a colonoscopy replacement, rather an alternative test for those who may have avoided testing all together.

As of September, more than 20,000 doctors nationwide were ordering the FDA-approved DNA stool test for their patients.

Doctor Paul Hartlaub from Wheaton Franciscan is one of them. He says the product does exactly what it's intended to do, and has helped find polyps for some of his patients. Including one who had several advanced polyps he says were nearing a cancerous stage.

“He would not have had that [polyps removed] done, he wouldn’t have gotten to the colonoscopy had he not had the Cologuard done. So I think it really made a difference.”

Exact Sciences spokesman JP Fielder released this statement, "What's clear from this year is that physicians and patients want Cologuard because it's an effective and easy-to-use colon cancer screening test." 

While everyone agrees more questions may need to be answered, they say Cologuard is better than doing nothing at all.  Ludwig says early detection is still key, and Cologuard is an option for someone who refuses a colonoscopy. “I think the overriding message is how important screening is for reducing mortality rates for colon and rectal cancer." he said.

According to Exact Sciences data, 42% of Cologuard users have never been screened for colon cancer.

Fielder said, “The team at Exact Sciences is focused on one mission: helping eradicate colon cancer through early detection.  With 80 million Americans eligible to use Cologuard, this is an audacious goal and an enormous opportunity.  When our mission is achieved, Wisconsin will be recognized as the innovative state that played a key role in eradicating one of the deadliest forms of cancer.”

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