Exact Sciences Debuts Positive Topline Results for Trial of Blood-Based Colorectal Cancer Screening Algorithm
Presented at ESMO, the findings reflect “a highly discriminate blood-based panel of methylated DNA markers” as well as a robust new marker class for identifying patients with precancerous lesions.
Performance data for a blood-based colorectal cancer (CRC) screening test under development by Exact Sciences demonstrated an 88.3% sensitivity for CRC and a 31.2% sensitivity for advanced precancerous lesions, the latter at a specificity of 90.1% for negative samples confirmed by colonoscopy, according to a statement from the company.1
The findings were presented September 16 at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain.1
“We took a unique scientific approach to developing this test by combining a novel panel of markers. This led to data that improve upon what we previously thought was possible with a blood-based colorectal cancer screening test,” Kevin Conroy, chairman and CEO, Exact Sciences, said in the statement.1
The results come from the company’s ongoing BLUE-C study—an extensive CRC trial including more than 26 000 adults aged 40 years and older, a cohort based on the 2020 US census.2 The prospective multicenter trial was designed to evaluate the blood-based CRC screening test in addition to the performance of Exact Sciences’ next generation multitarget stool DNA test, CologuardPlus.1
The study that was designed to optimize the blood test’s final algorithm simulated the screening population of the US in order to better predict the real-world performance of the novel screening approach, the company said. Exact Science investigators included more than 3000 blood samples, with 2900 blinded prospectively collected samples from the BLUE-C study.1 Also included were more than 90 advanced precancerous lesions and 60 case-collected CRC samples. The company noted that “performance degradation is expected for the advanced precancerous lesion sensitivity and overall CRC sensitivity.”1
The study yield, Exact Sciences said, is “a highly discriminate blood-based panel of methylated DNA markers” as well as a robust new marker class for identifying patients with precancerous lesions.1
The company anticipates that the BLUE-C results for the blood-based screening test will be available in the first half of 2025 and will serve as the foundation for a new drug application submission to the FDA. Cologuard Plus, meanwhile, has been slated for a commercial launch next year, pending FDA approval.1
In the BLUE-C head-to-head comparison of Cologuard Plus and a standard FIT exam, the FIT sensitivity for precancerous lesions was 23.3% compared with the stool-based multitarget DNA assessment that reached 43.4% sensitivity.2 That study was published earlier this year in the New England Journal of Medicine.
“A blood-based colorectal cancer screening test that can detect advanced precancerous lesions at a level comparable to the FIT test would be a breakthrough in this field,” Paul Limburg, Exact Sciences’ chief medical officer for screening, said in the news release.
“Results from this large, well-designed study show progress toward that goal and move us one step closer toward providing average-risk patients with another non-invasive screening option,” Limburg added.1
According to recent estimates, there are 60 million individuals who are untested and eligible for CRC screening in the US.3