Exact Sciences has unveiled Cologuard Plus, a non-invasive colorectal cancer (CRC) screening test intended for average-risk patients aged 45 years and above.
Approved by the US Food and Drug Administration (FDA) and covered by Medicare, Cologuard Plus shows 95% sensitivity in detecting colorectal cancers.
It also shows 94% specificity, promising fewer unnecessary follow-up colonoscopies in the US screening population.
Cologuard Plus builds on the success of the original Cologuard test, which has been used in over 19 million screenings over the past decade.
The new test offers enhanced performance while retaining the convenience of at-home sample collection, thereby setting a new standard for non-invasive CRC screening.
Exact Sciences screening executive vice president and general manager Jake Orville said: 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.
“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.”
Based on the BLUE-C study in 20,000 participants, Cologuard Plus features 95% sensitivity for CRC detection, compared to 71% with the faecal immunochemical test (FIT).
It also achieves a 40% reduction in false positives compared to the original Cologuard test.
The test also shows high sensitivity in precancerous lesions, with 43% sensitivity for advanced lesions and 74% for high-grade dysplasia.
A negative result from Cologuard Plus provides a 99.98% assurance that the patient does not have colorectal cancer, offering peace of mind to patients and clinicians alike.
Cologuard Plus is covered by Medicare and is recommended by the US Preventive Services Taskforce as a stool-based screening option.
It also satisfies three years of colorectal cancer screening quality measure credit, aiding healthcare professionals in meeting screening goals and improving patient outcomes.
The test is shipped directly to patients’ homes and integrates with the ExactNexus technology platform, which facilitates ordering, result delivery, and patient navigation.
Exact Sciences will continue offering the original Cologuard test, expanding Cologuard Plus, with over 96% of patients aged 45 and older facing no out-of-pocket costs for screening.
Exact Sciences screening chief medical officer Paul Limburg said: “Early detection helps save lives, and clinicians need highly accurate tests that their patients will complete.
“Cologuard Plus delivers unprecedented performance in a non-invasive 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.”
