TEST:

Cologuard Plus™

''Exact Sciences Corp...today announced new data being presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place October 24–29, 2025, at the Phoenix Convention Center in Phoenix, Arizona. The company’s research showcases leadership in advancing colorectal cancer (CRC) screening through high-quality science, real-world evidence, and innovations that improve screening adherence and access across diverse patient populations.''

''Exact Sciences Corp...today announced the publication of “Comparing Benefit-to-Burden Ratios of Endorsed and Emerging Colorectal Cancer Screening Strategies” in the Journal of the National Cancer Institute. The modeling study found that Cologuard Plus™, a triennial next-generation multitarget stool DNA (mt-sDNA) test, was the only noninvasive screening option shown to be efficient at guideline-recommended intervals and age ranges.''

"Exact Sciences Corp...today announced an expanded partnership with Humana Inc. to enhance access to colorectal cancer (CRC) screening...Through the partnership, the Cologuard Plus™ test will be available as an in-network service for eligible Humana Medicare Advantage members nationwide beginning in August 2025. Humana, the fourth largest private insurer in the United States, has approximately 5.8 million Medicare Advantage members."

FIT was the most cost-effective strategy for preventing CRC cases and deaths. At real-world adherence of 60%, mt-sRNA demonstrated the greatest clinical benefit and was more cost-effective than other molecular strategies.

"Exact Sciences Corp...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."

"Exact Sciences Corp...will present 11 abstracts at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) meeting January 23-25, 2025, in San Francisco."

"Exact Sciences Corp...announced the U.S. Food and Drug Administration (FDA) approved the Cologuard Plus test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC). FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening."

"Exact Sciences Corp...announced today the company will present six abstracts on strategies and advancements for improving colorectal cancer screening rates and outcomes during Digestive Disease Week (DDW) 2024, May 18-21 in Washington, D.C. This includes data on Cologuard, the best-in-class non-invasive screening test for colorectal cancer in patients 45 and older at average risk, and the next-generation Cologuard test in development, Cologuard Plus."

P=Obs | N=23,494 | BLUE-C (NCT04144751) | Sponsor: Exact Sciences Corporation | "Exact Sciences...announced online publication of the BLUE-C study results in The New England Journal of Medicine....Cologuard Plus met all BLUE-C study endpoints, demonstrating 94% sensitivity for CRC at 91% specificity including non-advanced findings, and 93% specificity including no findings. Specificity was even better in younger age groups, at 96% in 45-54 year olds. Cologuard Plus will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test. Results from BLUE-C also show Cologuard Plus significantly outperformed an independent FIT for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity."