Exact Sciences Launches the Cologuard Plus™ Test, Transforming Colorectal Cancer Screening

MADISON, Wis.--(BUSINESS WIRE)--Mar 31, 2025--

Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the launch of Cologuard Plus ™, the most accurate noninvasive colorectal cancer screening (CRC) test reported in studies to date.* FDA-approved for average-risk patients 45+ and covered by Medicare, the Cologuard Plus test detects 95% of colorectal cancers at 94% specificity in the U.S. screening population. 1† This performance means fewer unnecessary follow-up colonoscopies—up to a 40% reduction compared to the original Cologuard ® test 2 —and greater confidence in results.

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Building on the trust and success of Cologuard—used for more than 19 million screenings over the past decade—Cologuard Plus delivers even greater performance while maintaining the convenience of at-home collection. Backed by pivotal data from the 20,000+ person BLUE-C study published in the New England Journal of Medicine, the Cologuard Plus test sets a new standard for noninvasive CRC screening:

“Cologuard Plus builds on the proven performance of Cologuard,” said Jake Orville, Executive Vice President and General Manager, Screening. “Cologuard transformed colorectal cancer screening—driving an estimated 77% of the nationwide increase in CRC screening participation from 2018 to 2021 3 and enabling more than 19 million screenings to date. Cologuard Plus delivers key enhancements to help improve patient care and streamline health care delivery, bringing us closer to eradicating this highly preventable and treatable disease.”

Driving Better Outcomes Through Early Detection and Adherence

Colorectal cancer is highly treatable when caught early—survivable in about 90% of cases. ‡ Yet, nearly 48 million Americans remain unscreened. 4 Routine screening not only detects colorectal cancer when it’s most treatable but also prevents it by identifying precancerous growths so they can be removed. 5

“Early detection helps save lives, and clinicians need highly accurate tests that their patients will complete,” said Dr. Paul Limburg, Chief Medical Officer, Screening. “Cologuard Plus delivers unprecedented performance in a noninvasive test—detecting more cancers while significantly reducing false positives. Combined with strong patient adherence, it gives health care providers confidence that more patients will get screened and receive accurate results to drive better outcomes.”

Effective screening depends on patient adherence, and Cologuard Plus is designed to remove barriers to testing. A large national sample of Cologuard orders shows that 71% of patients complete their test within an average of 28 days, 6 significantly outperforming adherence rates seen in separate meta-analyses for FIT (42%) or colonoscopy referrals (38%). 7

Follow-up adherence is also strong—79% of patients who receive a positive Cologuard result complete a colonoscopy, and 83% of patients complete repeat screening three years later. 8,9 These adherence rates are critical in detecting cancer early and ensuring patients get the care they need.

Like the original Cologuard test, the Cologuard Plus test is shipped directly to a patient’s home and integrates with the ExactNexus ™ technology platform. This platform simplifies ordering, result delivery, and patient navigation—a feature proven to improve test completion rates. 10 As Exact Sciences works to expand patient access to the Cologuard Plus test, the original Cologuard test will remain available. Nationwide, more than 96% of patients aged 45 and older have no out-of-pocket costs for screening with the Cologuard test. 11§

* Based on relative comparison to published reports; not direct evidence from head-to-head comparisons with all other screening tests.
† 94% specificity was determined for adults with no colorectal neoplasia age-weighted to the U.S. population
‡ Based on 5-year survival.
§ Exact Sciences estimate based on historical patient billing as of November 2024. Exceptions for coverage may apply; only patients’ insurers can confirm how the Cologuard test would be covered.

References

About the Cologuard® and Cologuard Plus™ tests

Developed in collaboration with Mayo Clinic, the Cologuard® and Cologuard Plus™ tests are first-line, noninvasive colorectal cancer (CRC) screening options for adults aged 45 or older who are at average risk for the disease. The Cologuard test revolutionized CRC screening by detecting specific DNA markers and blood in stool associated with cancer and precancer, allowing patients to complete the test at home without special preparation or time off. It is included in national screening guidelines from the American Cancer Society (2018) and the U.S. Preventive Services Task Force (2021). Since its inception in 2014, Cologuard has been used to screen for more CRC 19 million times.

Building on this success, the FDA-approved Cologuard Plus test raises the performance bar even further and features novel biomarkers, improved laboratory processes, and enhanced sample stability. The Cologuard Plus test is expected to reduce false positives by more than 40% compared to the original Cologuard test, helping minimize unnecessary follow-up colonoscopies. Both tests demonstrate Exact Sciences’ commitment to improving CRC screening access and outcomes.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard ® and Oncotype ® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

NOTE: Exact Sciences, Cologuard, and Cologuard Plus are trademarks of Exact Sciences Corporation. The Cologuard test and Cologuard Plus test are only available in the U.S.

Forward-Looking Statement

This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated.

Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements regarding the development and commercialization of the Cologuard Plus test and the performance characteristics and health care benefits of the Cologuard Plus test in a commercial setting, as well as statements regarding the development and commercialization of Exact Sciences’ pipeline tests. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Cologuard Plus Box

ACERRA, Italy (AP) — Pope Leo XIV on Saturday greeted one by one families who lost loved ones to illegal toxic dumping in an area near Naples, tied to a multi-billion criminal racket run by the mafia.

Many paused to share photographs and other mementos of children and young people who have died or are battling cancer because of the pollution.

Leo's visit to the so-called Terra dei Fuochi, or Land of Fires, came on the eve of the 11th anniversary of Pope Francis’ big ecological encyclical Laudato Si (Praised Be), and indicates Leo’s commitment to carry on his predecessor’s environmental agenda.

“I have come first of all to gather the tears of those who have lost loved ones, killed by environmental pollution caused by unscrupulous people and organizations who for too long were able to act with impunity,” Leo said in remarks to family members and local clergy inside Acerra's cathedral.

The pontiff recalled that the area now dubbed the Land of Fires was once called “Campania felix,” Latin for blessed or fruitful countryside, "capable for enchanting for its fertility, its produce and its culture, like a hymn to life.

"And yet — here is death, of the land and of men,'' the pope said.

The European Court of Human Rights last year validated a generation of residents’ complaints that mafia dumping, burial and burning of toxic waste led to an increased rate of cancer and other ailments in the area of 90 municipalities around Caserta and Naples, encompassing a population of 2.9 million people.

The court found Italian authorities had known since 1988 about the toxic pollution, blamed on the Camorra crime syndicate that controls waste disposal, but failed to take necessary steps to protect the residents. The binding ruling gave Italy two years to set up a database about the toxic waste and verified health risks associated with living there.

Bishop Antonio Di Donna estimated 150 young people had died in the city of some 58,000 over the past three decades — emphasizing in his opening remarks that the number didn't take into account adults and victims in other municipalities.

He urged the pope to admonish those who continue to pollute, noting that the dumping of tons of toxic waste was reported a day earlier near Castera. Di Donna said that Italian officials had identified dozens more human-caused contamination sites throughout the country, including the Venetian port of Marghera, and the leaching of PFAS forever chemicals into groundwater near Vicenza.

"We say to those brothers of ours ensnared in evil and seized by a mirage of fabulous earnings: Convert, change your ways, because what you are doing is not only a crime, it is a sin that cries out to God for vengeance,'' the bishop said.

The pope later greeted the mayors of the 90 communities impacted by the toxic dumping, and greeted thousands of people waving yellow flags and chanting “Papa Leone” along the route of his popemobile and in a central piazza.

The victims include Maria Venturato, who died of cancer in 2016 at the age of 25. Her father, Angelo, said he hopes to speak with the pope to explain their reality, “not for me … for the next generation.”

“I’d like to give these young people a future, so I’m asking for the pope’s help with this. That is, I’m making a strong appeal to him to go to those in power and say, ‘Look, let’s heal this land of fires,’" he said on the eve of the pope's visit.

Inside the cathedral, Filomena Carolla presented the pope with a book containing memories from the life of her daughter, Tina De Angelis, who died of cancer at the age of 24.

“I’m just angry at the people who poisoned the soil, because what did our children have to do with it? What did they have to do with it, so young,” Carolla told The Associated Press on Friday.

Francis' plans to visit the area in 2020 were canceled due to the pandemic.

A man presents a pizza with the portrait of Pope Leo XIV during his a one-day pastoral visit in Acerra, Italy, Saturday, May 23, 2026. (AP Photo/Salvatore Laporta)

Pope Leo XIV delivers his speech during his meeting with clergy, religious and families of victims of environmental pollution in the Saint Mary of the Assumption Cathedral in Acerra, near Naples, Italy, Saturday, May 23, 2026. (AP Photo/Andrew Medichini)

Pope Leo XIV rides on his popemobile during his one-day pastoral visit in Acerra, Italy, Saturday, May 23, 2026. (AP Photo/Salvatore Laporta)

A man enters a grocery store with posters of Pope Leo XIV ahead of his visit to the southern Italian town of Acerra in the Terra dei Fuochi, or Land of Fires, Friday, May 22, 2026. (AP Photo/Andrew Medichini)

Acerra bishop Antonio Di Donna speaks during an interview with the Associated Press ahead of Pope Leo XIV's visit to the southern Italian town of Acerra in the Terra dei Fuochi, or Land of Fires, an area scarred by decades of pollution from illegal waste dumping and burning, much of it linked to organized criminal groups, Friday, May 22, 2026. (AP Photo/Andrew Medichini)

Illegal waste is seen on the side of a road in the outskirts of the southern Italian town of Acerra in the Terra dei Fuochi, or Land of Fires, an area scarred by decades of pollution from illegal waste dumping and burning, much of it linked to organized criminal groups, Friday, May 22, 2026, a day ahead of Pope Leo XIV's visit. (AP Photo/Andrew Medichini)

Illegal waste is seen on the side of a road in the outskirts of the southern Italian town of Acerra in the Terra dei Fuochi, or Land of Fires, an area scarred by decades of pollution from illegal waste dumping and burning, much of it linked to organized criminal groups, Friday, May 22, 2026, a day ahead of Pope Leo XIV's visit. (AP Photo/Andrew Medichini)

Angelo Venturato talks during an interview with the Associated Press next to photos of his daughter Maria who died at the age of 25 of a cancer he claims to be connected to decades of pollution from illegal waste dumping and burning, much of it linked to organized criminal groups, in the southern town of Acerra, Friday, May 22, 2026. (AP Photo/Andrew Medichini)