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
NEW YORK (AP) — Hunched over a sewing machine, Kil Bae is hemming a dress inside his Manhattan tailor shop when a new customer stops by with a vintage Tommy Hilfiger jacket he wants taken in.
The modeling agent paid $20 at a thrift store for his reversible bomber style that's plaid on one side and red on the other. He's willing to spend $280 to have it slimmed down. Alteration requests with such a price disparity would have seemed odd a few years ago, the tailor says, but are helping to keep the bobbins bobbing at his one-man shop, 85 Custom Tailor.
Bae carefully examines the cotton jacket before moving in to pin it, circling the customer like a sculptor with a chisel. He started training as a tailor at age 17, in his native South Korea. Now 63, he's part of a shrinking breed in the U.S., where professional sewers, dressmakers and tailors are aging out of the workforce as their services find fresh demand.
Shoppers who grew up on disposable fast fashion are enlisting tailors and seamstresses to give off-the-rack purchases a custom fit or personal flair, to revive secondhand finds or to extend the lives of their wardrobes, according to fashion industry experts. Weight-loss drugs like Zepbound and Wegovy mean more Americans are seeking adjusted waistbands, tapered sleeves and other types of resizing, Bae said.
“I recommend this job to young people because this one cannot be AI’d,” Bae said, noting artificial intelligence is automating pattern making but so far can't replicate a tailor's handiwork. “Different bodies. Different shape. They cannot copy like this. If I close this door, I can go out and find another one.”
But like engraving, repairing musical instruments and many other skilled trades, creating and fitting garments to individual specifications hasn't attracted enough entry-level workers over the years to replace the professionals retiring their pincushions after decades of performing their craft.
The U.S. Bureau of Labor Statistics estimated almost two years ago there were fewer than 17,000 tailors, custom sewers and dressmakers working in business establishments nationwide, a 30% decline from a decade earlier.
Including self-employed individuals and people working in private households, the median age for all sewers, dressmakers and tailors was 54 last year, 12 years older than the median for the entire employed population, according to the bureau.
The income that a proficiency with needle and thread commands relative to the skills needed and the physical toll of bending over detailed work for hours likely discourages teenagers and young adults from heeding Bae's advice, fashion industry experts said.
The mean annual wage tailors, dressmakers and custom sewers earned as of May 2024 was $44,050 a year, compared to $68,000 for all workers, according to BLS calculations.
“Most of fashion training is really aimed at mass production, not spending time in a shop handmaking a garment,” said Scott Carnz, the provost of LIM College, a for-profit college that offers degrees in disciplines from the business side of fashion. “The work is also tedious.”
Online job postings for tailors, dressmakers and sewers have remained fairly stable, according to Cory Stahle, an economist with the research arm of jobs site Indeed. Between February 2020 and the end of the same month this year, advertised openings decreased by roughly 2%, while postings for both marketing and software jobs declined by nearly 30%, he said.
“There is a kind of a craftsmanship ... that I think is an important piece that we can’t ignore,” Stahle, who focuses on the U.S. labor market, said.
Immigrants with and without permanent legal status, refugees and naturalized citizens have powered America's garment industry for well over a century.
An analysis of recent census data by the Migration Policy Institute found about 40% of tailors, dressmakers and sewers were foreign-born, according to Julia Gelatt, associate director of the nonpartisan think tank's U.S. Immigration Policy Program. The biggest shares came from Mexico, South Korea, Vietnam and China, she said.
To address a worsening labor shortage, the fashion industry is looking to create a new generation of master tailors.
Nordstrom, North America’s largest employer of tailors and alteration specialists, teamed up with New York's Fashion Institute of Technology to launch a nine-week program in advanced sewing and alteration techniques.
“Customarily, tailoring has never been part of the American skill set,” said FIT instructor and Broadway costume builder Michael Harrell, who teaches the course.
The fashion institute received 200 applications for the inaugural cohort of 15 students, who started in October and received certificates of completion in February, said Jacqueline Jenkins, the executive director of the school's Center for Continuing and Professional Studies.
The hands-on training was designed to prepare participants to work at Nordstrom. The luxury department store chain employs 1,500 people to provide tailoring and alternations, from hemming jeans and repairing rips to fitting suits and reworking evening gowns.
Ten members of the first class were hired or are in the process of being hired, Marco Esquivel, Nordstrom’s director of alterations, said.
“We owe it to the broader industry to ensure that this is an art form that exists for years and years to come and continues to serve customers both within our walls as well as outside,” Esquivel said.
Meanwhile, other retailers are expanding their tailoring services because of demand.
Brooks Brothers, a luxury brand that has made custom men’s clothes since the 1800s, tested a similar service for women at five stores last year. This year, it expanded bespoke women's tailoring to 40 more stores. Prices start at $165 for shirts and $1,398 for suits, the company said.
Back at 85 Custom Tailor, Bae asked more than once if the customer with the Tommy Hilfiger jacket was certain he wanted to proceed with the alterations. Jonathan Reiss, 33, was sure. He said he planned to wear the jacket often.
“I think I fell victim to buying cheap stuff, and then you realize it just falls apart or shrinks or it just doesn’t last long,” Reiss said.
Bae has a son who's a year older than Reiss. He tried to persuade him to go into tailoring. The son used to work with computers and then opened a bagel shop.
“Young people. They just want to find a job in computers,” Bae said. “I think that’s too boring. I think this is very interesting. Every time, I am drawing in my head. I am like an artist.”
Bae trained under his older sister and brother at their custom apparel shop about 93 miles (150 kilometers) from Seoul. After five years, he moved to South Korea's capital to work on custom orders and samples for various companies. He moved to the New York City area, where he worked as a pattern maker for Ralph Lauren, Donna Karan and other designer brands.
He opened his own shop in Connecticut in 2011, but the COVID-19 pandemic forced him to close after a decade. He reopened in his current location a year later.
He uses three different sewing machines: a basic one, another for for heavy materials like denim and leather, and an overlock machine, which cuts, trims, and finishes fabric edges simultaneously.
Bae said he intends to keep working as long as his hands stay steady enough.
“I'm always learning,” he said.
Tailor Marco Lema, 35, of Ecuador, works on an embroidered shirt at Nordstrom headquarters in New York, Monday, March 23, 2026. (AP Photo/Eduardo Munoz Alvarez)
Tailor Marco Lema, 35, of Ecuador, measures a denim alteration at Nordstrom headquarters in New York, Monday, March 23, 2026. (AP Photo/Eduardo Munoz Alvarez)
Tailor Marco Lema, 35, of Ecuador, works on a denim alteration at Nordstrom headquarters in New York, Monday, March 23, 2026. (AP Photo/Eduardo Munoz Alvarez)
Tailor, Kil Bae, works inside his shop on Friday, March 27, 2026, in New York. (AP Photo/Andres Kudacki)
Tailor, Kil Bae, works inside his shop on Friday, March 27, 2026, in New York. (AP Photo/Andres Kudacki)
Tailor, Kil Bae, poses for a photo inside his shop on Friday, March 27, 2026, in New York. (AP Photo/Andres Kudacki)
