Exact Sciences Debuts Positive Topline Results for Trial of Blood-Based Colorectal Cancer Screening Algorithm

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

_{©Sebastian Kaulitizky/stock.adobe.com}

“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

References

1. Exact Sciences Presents Data Demonstrating Advancement in Blood-based Colorectal Cancer Screening at ESMO 2024. News release. Exact Sciences. September 16, 2024. Accessed September 16, 2024.

2. Halsey G. Next-Generation Cologuard Surpasses FIT for Colorectal Cancer Detection in Pivotal BLUE-C Trial. Patient Care. March 21, 2024. https://www.patientcareonline.com/view/next-generation-cologuard-surpasses-fit-for-colorectal-cancer-detection-in-pivotal-blue-c-trial

3. Ebner DW, Kisiel JB, Fendrick AM, et al. Estimated Average-Risk Colorectal Cancer Screening-Eligible Population in the US. JAMA Netw Open. 2024;7(3):e245537. doi: 10.1001/jamanetworkopen.2024.5537