Blood-Based Test May Help Detect CRC in Average-Risk Population

By providing a more convenient option, Freenome's blood test for the early detection of CRC has the potential to boost screening adherence rates and improve accessibility for people in all communities,” according to Aasma Shaukat, MD, MPH.

The observational PREEMPT CRC trial (NCT04369053) met the primary end points of sensitivity and specificity of colorectal cancer (CRC) as detected by the Freenome test, according to a press release from Freenome.¹

The trial was designed to assess a blood-based test to determine early detection of CRC for average-risk adults. The prespecified analysis determined a 79.2% sensitivity for CRC screening. This helped to detect CRC by stage with 57.1% for stage I, 100% for stage II, 82.4% for stage III, and 100% for stage IV disease. Additionally, there was a 91.5% specificity for those with non-advanced colorectal neoplasia.

Of note, there was a 12.5% specificity in detecting advanced adenomas (AA), with 29% for AA with high-grade dysplasia. All end points highlighted were powered at 96% or higher. The Centers for Medicare and Medicaid Services National Coverage Determination found the specificity cutoff to be 90% with a corresponding increase of 14.8% for AA in maintaining CRC sensitivity. Additionally, when proteins were considered, investigators reported an improved sensitivity for AA and CRC by 16.4% vs 80.5%, respectively, were noted at the 90% cutoff.

The investigators noted that these findings will be presented at an upcoming scientific meeting.

"These results advance our early cancer detection programs toward mainstream clinical use, and we are grateful to the participants, partners and communities who helped accomplish this study," Lance Baldo, MD, chief medical officer at Freenome, said in the press release. "PREEMPT CRC was designed and executed with high scientific rigor and generated valuable data and insights that enable near- and long-term test improvements. These clinical performance metrics set a standard from which Freenome will continue to innovate, including the evaluation of prespecified test versioning."

The PREEMPT CRC trial was conducted at 200 sites and enrolled 48,995 patients who were asymptomatic or average risk, between 45 and 85 years old, and were scheduled to undergo a colonoscopy. After a predetermined cutoff date, 27,010 eligible patients enrolled consecutively on the study, with samples from them and 16,000 additional patients that were not utilized in this analysis.

The study focused on underserved communities and used a hybrid model for traditional and virtual recruiting. The participants included patients from 48 states to ensure a representative population. Real-world data were also collected for use during this trial.

The Freenome test was designed to use machine learning to identify those with cell-free biomarkers in the blood to detect cancer early.²

"While physicians have screening tools available for [CRC], the associated inconvenience and discomfort of these methods deter many from getting recommended screenings. By providing a more convenient option, Freenome's blood test for the early detection of CRC has the potential to boost screening adherence rates and improve accessibility for people in all communities,” said Aasma Shaukat, MD, MPH, professor of medicine at NYU Grossman School of Medicine and a principal investigator for the PREEMPT CRC study.¹

Patients were eligible for treatment if they met the age requirement, would undergo a colonoscopy, could provide a blood sample, and give informed consent.² If patients had a known hereditary gastrointestinal cancer syndrome, a personal history of various gastrointestinal-related ailments, a medical condition that could prevent enrollment, or were enrolled on another clinical trial receiving experimental treatment, they would be excluded from the trial.

"We built Freenome to be able to integrate many analytes and computational methods into one test to implement a ‘staircase’ of increasing performance for the benefit of patient care. The performance of this initial version establishes a strong foundation and we expect to broaden it to other cancers. Our platform uniquely enables our team to efficiently iterate as we consistently push to achieve what is possible for patients,” concluded Mike Nolan, chief executive officer at Freenome.¹

References

1. Freenome announces topline results for PREEMPT CRC® to validate the first version of its blood-based test for the early detection of colorectal cancer. News release. Freenome. April 2, 2024. Accessed April 3, 2024. https://shorturl.at/uCN46
2. Prevention of colorectal cancer through multiomics blood testing (PREEMPT CRC). ClinicalTrials.gov. Accessed April 3, 2024. https://shorturl.at/EJTX6