MON AM News: FDA approves upgraded version of Exact Sciences’ Cologuard test

October 6, 2024

— The FDA has approved an upgraded version of Exact Sciences’ Cologuard test, the Madison-based diagnostics and screening company announced.

Kevin Conroy, chairman and CEO of Exact Sciences, says the Cologuard Plus test “sets a new performance standard” for non-invasive colorectal cancer screening.

“Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30 percent,” Conroy said Friday in a statement. “This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening.”

The federal agency’s approval was based on results of the BLUE-C study, which had almost 19,000 average-risk participants. It found the Cologuard Plus test “significantly outperformed” an independent fecal immunochemical test on a number of measures, the release shows.

Cologuard Plus, which was developed in partnership with Mayo Clinic, is now approved for adults aged 45 years or older that are at average risk for developing colorectal cancer, according to the announcement. The company says it plans to launch the test with Medicare coverage and U.S. Preventive Services Taskforce guideline inclusion next year.

Dr. Thomas Imperiale, professor of medicine at the Indiana University School of Medicine, is the principal investigator for the BLUE-C study. He says he’s confident the test will help improve the outlook for patients with colorectal cancer, also noting its low risk for false positive results.

“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early – when it is most treatable — and find advanced precancers, which can prevent cases of this cancer,” he said, calling Cologuard Plus a “strong option for first-line screening of average risk patients.”

The original Cologuard test has been used more than 17 million times since being approved by the FDA in 2014, and Exact Sciences says it has “helped meaningfully improve” national colorectal cancer screening rates.

See more in the release.

Top headlines from the Health Care Report…

— A recent survey of manufacturers in Wisconsin finds 85% of those providing health insurance to employees expect their health care costs to rise this year, a substantial increase from previous surveys.

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— An engineering professor at Marquette University is getting $2 million in funding to develop a new naval fuel combustion system that can operate with various types of fuels.

Adam Dempsey, an assistant professor of mechanical engineering, is getting the funding from the U.S. Office of Naval Research, the Milwaukee-based university announced recently. The system he’s developing is meant to operate with a “wide range” of fuels with lower carbon intensity, with a goal of reducing greenhouse gas emissions.

The engines he’s focused on operate on a form of diesel fuel, and Demsey’s research team aims to develop a system that can run on jet fuel, sustainable aviation fuel, hydrogen and others, the release shows, while still being able to use the current standard naval F76 diesel fuel.

Dempsey will be working with Casey Allen, an associate professor of mechanical engineering at Marquette, alongside others at UW-Madison and a Connecticut business called Precision Combustion, Inc.

He highlights the “imminent need” to limit greenhouse gas emissions across transportation and power generation sectors, including naval marine vessels.

“The most pragmatic and impactful way to decarbonize is by using low carbon intensity fuels,” Dempsey said in the release. “The commercial maritime industry is moving quickly to decarbonize their internal combustion engines, but they are either dual fuel and not capable of operating solely on a low carbon fuel, or are designed around a single low carbon fuel and are not fuel flexible.”

See more in the release.

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