The US Food and Drug Administration (FDA) has approved the second version of Exact Science’s at-home colorectal cancer (CRC) test, Cologuard Plus, in adults aged 45 years and older.
The approval comes a decade years after the US regulatory agency cleared the original Cologuard. Exact Sciences says that the Cologuard Plus test offers additional biomarkers and has fewer false positives than its predecessor. The company plans to launch Cologuard Plus Medicare coverage across the US in 2025.
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The approval was also well received by Exact Sciences’ investors, the company’s stock was up by 2.9% at market close on 4 October, compared to market close on the previous day.
The FDA approval was based on the positive data from a prospective BLUE-C trial (NCT04144738). The study compared the Cologuard Plus test performance with the faecal immunochemical test (FIT), another non-invasive CRC screening test and consisted of 20,000 participants. The trial met its primary endpoints by demonstrating a 95% overall sensitivity rating and a 92% specificity rating for detecting CRC.
The test showed a 93% sensitivity rating whilst detecting Stage I-III CRC, 75% sensitivity in detecting high-grade dysplasia and a 43% sensitivity in detecting advanced precancerous lesions. The subgroup sensitivity by Cologuard Plus outperformed FIT’s, which showed a 65%, 47% and 23% sensitivity in detecting Stage I-III CRC, high-grade dysplasia and advanced precancerous lesions, respectively.
In its announcement Exact Sciences touted the success of the original Cologuard, noting that the test has been used more than 16 million times in the last decade. The company also noted that the Cologuard test has contributed to 77% of the improvement in CRC screening rates between 2018 and 2021, adding that the early cancer detection through Cologuard has saved over $22bn in health care costs in the US.
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