Exact Sciences moves forward with groundbreaking technology

Success Stories | Madison Region Economic Partnership (MADREP)

One of the top performers in Madison’s bioscience community is Exact Sciences, a company that developed a leading-edge technology for detecting colon cancer in its early, most curable stages.

As a small biotech firm in Boston in the late 1990s, Exact Sciences struggled for 14 years to develop a non-invasive colon cancer screening test. In April 2009 the company overhauled its leadership and moved to Madison. A partnership with Mayo Clinic accelerated the development of Cologuard, the first at-home, noninvasive, stool-based DNA screening test for colon cancer.

Madison-based Exact Sciences developed the first-of-its-kind non-invasive colon cancer screening test.

Madison-based Exact Sciences developed the first-of-its-kind non-invasive colon cancer screening test.

In 2014, Cologuard was approved simultaneously by the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS) for the detection of colon cancer (92 percent sensitive across all four stages of cancer) and even pre-cancers (69 percent sensitive for detecting the polyps most likely to develop into cancer). These approvals made the test immediately available to millions of Medicare patients, with no out-of-pocket cost.

Since then Exact Sciences has experienced consistent quarterly business growth, completing 4,000, 11,000, 21,000 and 34,000 Cologuard tests between Q4 2014 and Q3 2015. To date more than 21,000 physicians have prescribed Cologuard to their patients. When the U.S. Preventive Services Task Force’s draft guidelines recently placed Cologuard in a new category of “alternative” screening tests for colorectal cancer, however, some concerns were expressed by Wall Street. The task force explained it had ranked Cologuard as an “alternative” method because there was “less mature evidence” compared to the “recommended” methods, such as the fecal immunochemical test (FIT), flexible sigmoidoscopy with annual FIT and colonoscopy.

“During the task force’s public-comment period, we requested clarity on the standing of Cologuard and outlined why it should be included as a recommended screening option,” said Kevin Conroy, president and CEO of Exact Sciences. “However, there is limited history of the task force significantly changing its perspective between
the release of draft and final guidelines.”

Over the past six years, Exact Sciences has grown from two employees to more than 700. These roles include research and development, manufacturing, technical and non-technical lab work, marketing and sales, customer care and billing. The company also built its own state-of-the-art laboratory in Madison that is capable of processing more than one million Cologuard tests annually.

Exact Sciences looks forward to continued growth. The company is exploring new ways of using its unique DNA-screening technology to detect other cancers as well. Its research teams have partnerships with Mayo Clinic to develop new tests for esophageal and pancreatic cancers and are working on a blood-based test for lung cancer.

Exact Sciences is also very interested in developing a corporate campus at the University of Wisconsin’s University Research Park
in Madison.

“This would be an excellent opportunity to continue benefitting from the UW System’s world-class talent, while engaging with the region’s top biotech companies in University Research Park,” said Conroy. “The diversity of our research and development functions also gives us the opportunity to hire from a range of skillsets across Wisconsin.”

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One of the top performers in Madison’s bioscience community is Exact Sciences, a company that developed a leading-edge technology for detecting colon cancer in its early, most curable stages.

As a small biotech firm in Boston in the late 1990s, Exact Sciences struggled for 14 years to develop a non-invasive colon cancer screening test. In April 2009 the company overhauled its leadership and moved to Madison. A partnership with Mayo Clinic accelerated the development of Cologuard, the first at-home, noninvasive, stool-based DNA screening test for colon cancer.

Madison-based Exact Sciences developed the first-of-its-kind non-invasive colon cancer screening test.

Madison-based Exact Sciences developed the first-of-its-kind non-invasive colon cancer screening test.

In 2014, Cologuard was approved simultaneously by the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS) for the detection of colon cancer (92 percent sensitive across all four stages of cancer) and even pre-cancers (69 percent sensitive for detecting the polyps most likely to develop into cancer). These approvals made the test immediately available to millions of Medicare patients, with no out-of-pocket cost.

Since then Exact Sciences has experienced consistent quarterly business growth, completing 4,000, 11,000, 21,000 and 34,000 Cologuard tests between Q4 2014 and Q3 2015. To date more than 21,000 physicians have prescribed Cologuard to their patients. When the U.S. Preventive Services Task Force’s draft guidelines recently placed Cologuard in a new category of “alternative” screening tests for colorectal cancer, however, some concerns were expressed by Wall Street. The task force explained it had ranked Cologuard as an “alternative” method because there was “less mature evidence” compared to the “recommended” methods, such as the fecal immunochemical test (FIT), flexible sigmoidoscopy with annual FIT and colonoscopy.

“During the task force’s public-comment period, we requested clarity on the standing of Cologuard and outlined why it should be included as a recommended screening option,” said Kevin Conroy, president and CEO of Exact Sciences. “However, there is limited history of the task force significantly changing its perspective between
the release of draft and final guidelines.”

Over the past six years, Exact Sciences has grown from two employees to more than 700. These roles include research and development, manufacturing, technical and non-technical lab work, marketing and sales, customer care and billing. The company also built its own state-of-the-art laboratory in Madison that is capable of processing more than one million Cologuard tests annually.

Exact Sciences looks forward to continued growth. The company is exploring new ways of using its unique DNA-screening technology to detect other cancers as well. Its research teams have partnerships with Mayo Clinic to develop new tests for esophageal and pancreatic cancers and are working on a blood-based test for lung cancer.

Exact Sciences is also very interested in developing a corporate campus at the University of Wisconsin’s University Research Park
in Madison.

“This would be an excellent opportunity to continue benefitting from the UW System’s world-class talent, while engaging with the region’s top biotech companies in University Research Park,” said Conroy. “The diversity of our research and development functions also gives us the opportunity to hire from a range of skillsets across Wisconsin.”

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