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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250331788957/en/
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
WASHINGTON (AP) — President Donald Trump made new threats to escalate strikes in Iran on Sunday, a day after U.S. forces pulled off a dramatic rescue of an aviator whose plane fell behind enemy lines after Iran had downed it days earlier.
Iran showed no signs of backing down, striking economic and infrastructure targets in neighboring Gulf Arab countries even as Trump demanded Iran reopen the Strait of Hormuz.
In an expletive-laden post Sunday morning, Trump expanded upon earlier threats, promising strikes on Iran’s power plants and bridges. He vowed the “crazy bastards” would be “living in Hell” if the waterway isn’t opened to marine traffic by Tuesday. He ended his post with “Praise be to Allah.”
The U.S. airman's extraction followed a search-and-rescue operation after the Friday crash of the F-15E Strike Eagle, as Iran also promised a reward for anyone who turned in an “enemy pilot.” Trump said the servicemember was injured but in stable condition.
A second crew member was rescued earlier.
The fighter jet was the first American aircraft to have crashed in Iranian territory since the U.S. and Israel launched the war, striking Iran on Feb. 28. Both sides have threatened and hit civilian targets, bringing warnings of possible war crimes. The war has killed thousands, shaken global markets, cut off key shipping routes and spiked fuel prices.
As Iran continues to exert control over the Strait of Hormuz, Trump, in an earlier social media post, threatened to unleash “all Hell” if it isn’t opened by Monday. He has issued such threats before and extended them when mediators have claimed progress toward ending the war on agreeable terms.
The threats came after Trump said last week that the U.S. had “decimated” Iran and would finish the war “very fast.” Two days later, Iran shot down two U.S. military planes, showing the ongoing perils of the bombing campaign and the ability of a degraded Iranian military to continue to hit back.
The other jet to go down was a U.S. A-10 attack aircraft. Neither the status of the crew nor exactly where it crashed was immediately known.
On Sunday, Iran’s state TV aired a video showing what it claimed were parts of American aircraft shot down by Iranian forces, along with a photo of thick, black smoke rising into the air. The broadcaster said Iran had shot down an American transport plane and two helicopters that were part of the rescue operation.
However, a regional intelligence official briefed on the mission told The Associated Press that the U.S. military blew up two transport planes due to a technical malfunction, forcing it to bring in additional aircraft to complete the rescue. The official spoke on condition of anonymity to discuss the covert mission.
Iran’s military joint command on Sunday claimed that four U.S. aircraft were destroyed during the rescue operation and warned of stepping up retaliatory attacks on regional oil and civilian infrastructure if the U.S. and Israel attacked such targets in the Islamic Republic, according to state television.
“We once again repeat: if you commit aggression again and strike civilian facilities, our responses will be more forceful,” a spokesman said in comments run by IRNA news agency.
In Kuwait, Iranian drone attacks caused significant damage to power plants and a petrochemical plant. They also put a water desalination station out of service, according to the Ministry of Electricity. No injuries were reported, the ministry said.
In Bahrain, a drone attack caused a fire at one of the national oil company’s storage facilities and a state-run petrochemical plant, the kingdom’s official news agency said.
In the United Arab Emirates, authorities responded to fires at a petrochemical plant in Ruwais that they said were caused by intercepted debris, halting operations.
The strikes came a day after Israel struck a petrochemical plant in Iran that Prime Minister Benjamin Netanyahu said generated revenue that it had used to fund the war.
The petrochemical industry is a key sector in many Gulf states. Plants in Bahrain, Kuwait, the UAE and Iran convert oil and gas into products like plastics, polymers and fertilizer, bringing in billions in export revenue.
Trump renewed his threats for Iran to open up the Strait of Hormuz by Monday or face consequences, writing Saturday in a social media post: “Remember when I gave Iran ten days to MAKE A DEAL or OPEN UP THE HORMUZ STRAIT. Time is running out — 48 hours before all Hell will reign down on them.”
The waterway is a critical chokepoint for commerical trade, especially oil and gas moving from the Persian Gulf to Europe and Asia. Disruptions there have injected volatility into the market and pushed oil and gas-importing countries to seek alternative sources.
“The doors of hell will be opened to you” if Iran’s infrastructure is attacked, Gen. Ali Abdollahi Aliabadi with the country’s joint military command said late Saturday in response to Trump’s renewed threat, state media reported. In turn, the general threatened all infrastructure used by the U.S. military in the region.
Pakistan’s Foreign Ministry spokesperson, Tahir Andrabi, told AP that his government’s efforts to broker a ceasefire are “right on track” after Islamabad last week said that it would soon host talks between the U.S. and Iran.
Mediators from Pakistan, Turkey and Egypt were working to bring the U.S. and Iran to the negotiating table, according to two regional officials.
The proposed compromise includes a cessation of hostilities to allow a diplomatic settlement, according to a regional official involved in the efforts and a Gulf diplomat briefed on the matter. They spoke on condition of anonymity to discuss closed-door diplomacy.
More than 1,900 people have been killed in Iran since the war began.
In Gulf Arab states and the occupied West Bank, more than two dozen people have died, while 19 have been reported dead in Israel and 13 U.S. service members have been killed. In Lebanon, more than 1,400 people have been killed and more than 1 million people have been displaced. Ten Israeli soldiers have died there.
This report has been corrected to show that Borealis is an Austrian company, not Australian.
Metz reported from Jerusalem and Magdy from Cairo. Jon Gambrell in Dubai, United Arab Emirates, and Munir Ahmed in Islamabad contributed to this report.
Vehicles and motorcycles move past an anti-U.S. billboard depicting the American aircrafts into the Iranian armed forces fishing net with signs that read in Farsi: "The Strait of Hormuz will remain closed, The entire Persian Gulf is our hunting ground," at the Eqelab-e-Eslami, or Islamic Revolution square in downtown Tehran, Iran, Sunday, April 5, 2026. (AP Photo/Vahid Salemi)
In this image provided by Sepahnews, the Iranian Revolutionary Guard's official website, wreckage is shown at what Iran's state TV claimed was the site of a downed American transport plane and two helicopters involved in a rescue operation, in Isfahan province, Iran, April, 2026. (Sepahnews via AP)
In this image provided by Sepahnews, the Iranian Revolutionary Guard's official website, wreckage is shown at what Iran's state TV claimed was the site of a downed American transport plane and two helicopters involved in a rescue operation, in Isfahan province, Iran, April, 2026. (Sepahnews via AP)
In this image provided by Sepahnews, the Iranian Revolutionary Guard's official website, black smoke rises into the air at what Iran's state TV claimed was the site where an American transport plane and two helicopters involved in a rescue operation were shot down, in Isfahan province, Iran, April, 2026. (Sepahnews via AP)
In this image provided by Sepahnews, the Iranian Revolutionary Guard's official website, wreckage is shown at what Iran's state TV claimed was the site of a downed American transport plane and two helicopters involved in a rescue operation, in Isfahan province, Iran, April, 2026. (Sepahnews via AP)
Members of Lebanon's General Security stand at the Masnaa border crossing in the Bekaa valley, eastern Lebanon, Sunday, April 5, 2026. (AP Photo/Bilal Hussein)
A man, who fled Israeli bombings in southern Lebanon with his family, sleeps in his car used as shelter, along a seaside promenade in downtown Beirut, Lebanon, Sunday, April 5, 2026. (AP Photo/Emilio Morenatti)
Followers of Iraq's Shiite cleric Muqtada al-Sadr chant slogans as they wave national Iraqi flag during a protest against U.S. and Israeli attacks on multiple cities across Iran, in Tahrir Square, Baghdad, Baghdad, Iraq, Saturday, April 4, 2026. (AP Photo/Hadi Mizban)
A bedroom is damaged in a building struck in an Israeli airstrike in the southern port city of Tyre, Lebanon, Saturday, April 4, 2026. (AP Photo/Mohammed Zaatari)
Pedetrians walk by a destroyed building within the Grand Hosseiniyeh, with the mosque visible in the background, which officials at the site say was hit by U.S.-Israeli airstrikes Tuesday, in Zanjan, Iran, Saturday, April 4, 2026. (AP Photo/Francisco Seco)
Police officers and their horses take cover in an underground parking garage as sirens warn of an incoming missile fired from Yemen in Tel Aviv, Israel, Saturday, April 4, 2026. (AP Photo/Maya Levin)
A man looks at a destroyed building within the Grand Hosseiniyeh complex that officials say was hit by U.S.-Israeli airstrikes Tuesday in Zanjan, Iran, Saturday, April 4, 2026. (AP Photo/Francisco Seco)
