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

CARACAS, Venezuela (AP) — Venezuela’s acting President Delcy Rodríguez on Thursday asked lawmakers to approve reforms to the oil industry that would open the doors to greater foreign investment during her first state of the union speech less than two weeks after its longtime leader was toppled by the United States.

Rodríguez, who has been under pressure by the Trump administration to fall in line with its vision for the oil-rich nation, said sales of Venezuelan oil would go to bolster crisis-stricken health services, economic development and other infrastructure projects.

She outlined a distinct vision for the future, straying from her predecessors, who have long railed against American intervention in Venezeula. “Let us not be afraid of diplomacy” with the U.S., said Rodriguez, the former vice president who must now navigate competing pressures from the Trump administration and a government loyal to former President Nicolás Maduro.

The speech, which was broadcast on a delay in Venezuela, came one day after Rodríguez said her government would continue releasing prisoners detained under Maduro in what she described as “a new political moment” since his ouster.

On Thursday, Trump met at the White House with Venezuelan opposition leader María Corina Machado, whose political party is widely considered to have won 2024 elections rejected by Maduro. But in endorsing Rodríguez, who served as Maduro’s vice president since 2018, Trump has sidelined Machado.

Rodríguez, who had a call with Trump earlier this week, said Wednesday evening on state television that her government would use “every dollar” earned from oil sales to overhaul the nation’s public health care system. Hospitals and other health care facilities across the country have long been crumbling, and patients are asked to provide practically all supplies needed for their care, from syringes to surgical screws.

The acting president must walk a tightrope, balancing pressures from both Washington and top Venezuelan officials who hold sway over Venezuela's security forces and strongly oppose the U.S. Her recent public speeches reflect those tensions — vacillating from conciliatory calls for cooperation with the U.S., to defiant rants echoing the anti-imperialist rhetoric of her toppled predecessor.

American authorities have long railed against a government they describe as a “dictatorship,” while Venezuela’s government has built a powerful populist ethos sharply opposed to U.S. meddling in its affairs.

For the foreseeable future, Rodríguez's government has been effectively relieved of having to hold elections. That's because when Venezuela’s high court granted Rodríguez presidential powers on an acting basis, it cited a provision of the constitution that allows the vice president to take over for a renewable period of 90 days.

Trump enlisted Rodríguez to help secure U.S. control over Venezuela’s oil sales despite sanctioning her for human rights violations during his first term. To ensure she does his bidding, Trump threatened Rodríguez earlier this month with a “situation probably worse than Maduro.”

Maduro, who is being held in a Brooklyn jail, has pleaded not guilty to drug-trafficking charges.

Before Rodríguez’s speech on Thursday, a group of government supporters was allowed into the presidential palace, where they chanted for Maduro, who the government insists remains the country’s president. “Maduro, resist, the people are rising,” they shouted.

Follow AP’s coverage of Latin America and the Caribbean at https://apnews.com/hub/latin-america

Venezuela's acting President Delcy Rodriguez makes a statement to the press at Miraflores presidential palace in Caracas, Venezuela, Wednesday, Jan. 14, 2026. (AP Photo/Ariana Cubillos)

Venezuela's acting President Delcy Rodriguez, center, smiles flanked by Interior Minister Diosdado Cabello, right, and National Assembly President Jorge Rodriguez after making a statement to the press at Miraflores presidential palace in Caracas, Venezuela, Wednesday, Jan. 14, 2026. (AP Photo/Ariana Cubillos)