FDA approves expansion of Cologuard, at-home colon cancer screening test

Exact Sciences Corp., a molecular diagnostics company that focuses on early detection and prevention of colorectal cancer, on Monday gained U.S. Food and Drug Administration (FDA) approval for its noninvasive colorectal cancer screening test, Cologuard, for use in Americans ages 45 to 49.

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“It's exciting for Americans age 45 to 49 because the screening age is now five years earlier,” Exact Sciences CEO Kevin Conroy told FOX Business’ Maria Bartiromo during an exclusive interview. “There are 20 million Americans who need to get screened for colon cancer.”

Exact Sciences worked with the Mayo Clinic to develop the test, which is non-invasive, and can be done in the privacy of your own home.

“It's accurate,” said Conroy adding that “It’s a really easy way to get screened.”

The incidence rate of colon cancer has doubled for people under 50, however no one knows why, he said, which is why regular screening is critical.


Colon cancer is known as the most preventable, yet least prevented of all the cancers, he said, and is the second deadliest cancer in the U.S.

“If you find a precancerous polyp and remove it, you can actually prevent cancer. And then if you detect it early nine out of 10 people Stage 1 and 2 cancers early cancers survive versus one out of 10 if detected late.”

According to Conroy Cologuard detects 94 percent of early stage colon cancers.