Cologuard is getting an upgrade after 10 years on the market, as Exact Sciences starts to roll out the new version of its home screening test for colorectal cancer.
The company said the addition of new genetic biomarkers to the stool DNA test has cut its rate of false positives, resulting in fewer referrals to unnecessary colonoscopies, while maintaining its sensitivity in detecting the signs of growing tumors and advanced precancerous polyps.
Cologuard Plus, which was approved by the FDA last October and will be covered by Medicare, will also largely present the same process to users familiar with the original screener—though, via a collaboration with the Mayo Clinic, the new test is better at stabilizing the quality of its samples, which adds extra time for returning the kit to Exact Sciences’ laboratory.
“Cologuard transformed colorectal cancer screening—driving an estimated 77% of the nationwide increase in CRC screening participation from 2018 to 2021 and enabling more than 19 million screenings to date,” Jake Orville, Exact Sciences’ general manager for screening, said in a statement. “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.”
The company estimates that nearly 48 million people in the U.S. still have not been screened for colorectal cancer.
Exact Sciences said the original Cologuard test will still be available during a transition period, while the company works to gather coverage from commercial payers. On the company’s last quarterly earnings call in February, Chief Financial Officer Aaron Bloomer said Cologuard Plus will initially be available to Medicare patients, who represented about 15% of Cologuard sales last year, and would start to impact revenues in the latter half of 2025.