Dive Brief:
- Labcorp has made the colorectal cancer screening test ColoSense available nationwide, boosting access to a challenger to Exact Sciences’ Cologuard.
- The nationwide rollout, which Labcorp disclosed Monday, comes weeks after the Centers for Medicare and Medicaid Services approved coverage for ColoSense, and the American Cancer Society named the test as a preferred option in its colorectal cancer screening guidelines.
- Labcorp secured the right to distribute the test from Geneoscopy in 2023. The Food and Drug Administration approved the test in 2024 and authorized a collection kit in 2025.
Dive Insight:
Like Cologuard, which the FDA approved in 2014, ColoSense is a stool-based screening test for colorectal cancer. Cologuard detects abnormal DNA and blood, while ColoSense tests for RNA markers and blood. A Geneoscopy-sponsored clinical trial found ColoSense and Cologuard had comparable levels of sensitivity for colorectal cancer and advanced adenomas.
Geneoscopy has identified the stool sample collection process as a way to differentiate ColoSense from Cologuard. Exact Sciences, now part of Abbott, requires Cologuard users to scrape the surface of their stool with a probe. Users ship the probe and the stool sample in separate containers.
The ColoSense collection kit eliminates the need to scrape the stool. Users only collect and ship their stool samples. A Labcorp survey found that 41% of at-home screening test users were uncomfortable preparing the sample, and 34% said the process felt messy. ColoSense offers a cleaner, simplified collection process that minimizes sample handling to lower barriers to screening, Labcorp said.
Exact Sciences has continued to grow Cologuard in the face of competition from ColoSense. Screening sales, which primarily include laboratory service revenue from Cologuard and PreventionGenetics tests, increased roughly 20% to $2.53 billion last year.
In 2023, Exact Sciences filed a lawsuit against Geneoscopy, alleging patent infringement. Geneoscopy hailed a win in the legal battle in February, claiming that a decision removed the last patent hurdle in the way of ColoSense. The Patent Trial and Appeal Board has invalidated all patent claims asserted by Exact Sciences in the litigation, according to Geneoscopy.
