July 22, 2025

The alarming trend of early-onset colorectal cancer has prompted a surge in the quest for more accessible screening methods. Recently, the average age of individuals diagnosed with colorectal cancer in the U.S. has dropped significantly, spurring hospitals like MD Anderson to initiate specialized programs for younger patients. Despite these efforts, the preferred screening method, colonoscopy, remains recommended primarily for those 45 and older unless risk factors dictate otherwise.
As the public grapples with the invasive nature of colonoscopies, the market has responded. Cologuard, a non-invasive at-home test developed by Exact Sciences, has provided a less daunting option, generating substantial revenue and broadening screening participation since its FDA approval in 2014. However, this innovation has not come without its share of legal strife.
Exact Sciences has taken aggressive steps to protect its lucrative product with numerous patents, but the entrance of ColoSense, a new competitor from Geneoscopy, has sparked a fierce patent infringement lawsuit. As Geneoscopy prepares to launch ColoSense in collaboration with Labcorp, the legal battles have intensified, with a key patent belonging to Exact being invalidated by the Patent Trial and Appeal Board (PTAB) in July 2025. This decision came after the PTAB found no nexus between the commercial success of Cologuard and the claims of the patent, dealing a significant blow to Exact Sciences.
This legal turmoil underscores a larger issue within the medical and patent fields—how intellectual property rights are balanced against the need for medical advancements. As companies like Exact and Geneoscopy vie for dominance in the colorectal cancer screening market, the ultimate hope is that competition will lead to better and more affordable options for patients. This is especially critical as the incidence of colorectal cancer in younger populations continues to rise, underscoring the urgent need for accessible and effective screening methods.
As the case progresses towards a trial set for November 2026, the medical community and potential patients await further developments. The outcome could have significant implications for how new medical technologies are protected and challenged in the market, potentially influencing how quickly and affordably new innovations can reach those in need. With patient lives at stake, the resolution of this legal battle will be closely watched by many, hopeful for a future where effective screening tools are within easy reach of everyone at risk.