FDA approves local company’s DNA-based colon cancer test

Exact Sciences has received Medicare approval, is working with other carriers

MADISON, Wis. — Madison-based Exact Sciences’ new colon cancer test could be a game changer when it comes to detecting and preventing the nation’s second-most-deadly cancer.

Late Monday, the Food and Drug Administration approved the DNA-based test, called Cologuard. The test is able to detect the blood protein hemoglobin and certain colorectal cancer DNA mutations.

“It tells you with 94 percent accuracy if you have a stage 1 or stage 2 cancer,” Exact Sciences’ Chief Operating Officer Maneesh Arora said. “A 92 percent sensitivity overall. That is absolutely unheard of.”

The colonoscopy has historically been colon cancer’s only available test. However, the preparation, doctor visit and what some patients consider invasive testing has historically meant many do not chose to receive the test.

Now, patients can go to their doctor, request Cologuard and, Arora said, by Sept. 2 have it sent to their homes. When a sample is sent back to the Madison lab, technicians will check for any signs of trouble.

“So, if you test positive on Cologuard, the colonoscopy is the therapeutic,” Arora said. “You go have your colonoscopy, have the precancerous lesion removed.”

The company has already received Medicare approval, and is reportedly in the process of working with other insurance carriers to cover the test’s $599 cost.

The Madison Chamber of Commerce believes Cologuard’s approval could be big business for the city. Exact Sciences currently has 200 employees.