Freenome Announces JAMA Publication of Data from Pivotal Study of its Blood-Based Test for Colorectal Cancer

– PREEMPT CRC, the largest prospective study of its kind, met all primary efficacy endpoints and surpassed CMS coverage requirements for sensitivity and specificity in the intended use population – 

– FDA premarket approval submission is underway, with completion anticipated mid-2025 – 

BRISBANE, Calif., June 2, 2025 /PRNewswire/ -- Freenome, a biotechnology company pioneering an early cancer detection platform, today announced the publication of detailed results from the pivotal PREEMPT CRC study in JAMA.¹ The publication presents findings from the largest prospective study of a blood-based screening test for colorectal cancer (CRC), involving 48,995 average-risk adults aged 45 to 85 who underwent a routine colonoscopy following a blood draw.

Based on data from the 27,010 eligible participants who enrolled consecutively in the study after a predetermined cut-off date, the test met all prespecified primary acceptance criteria. The publication also includes a pre-specified analysis that weighted test performance to match the sex and age distribution of the U.S. population, a method used by the U.S. Food and Drug Administration (FDA) for other CRC screening products.² 

"Despite clear guidelines, many communities still face barriers that lead to fewer people getting screened for colorectal cancer," said Aasma Shaukat, M.D., M.P.H., professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study. "The study's rigor and scale provide confidence in the test's performance. Its high sensitivity means it can detect most cancers, while high specificity helps avoid false alarms. Both are critical to making screening effective and efficient, as well as easier for patients and providers."

More than two out of five U.S. adults of screening age are not current with recommended CRC screening. Barriers such as discomfort, preparation or access often lead to low adoption rates. Importantly, among adults aged 45–49, who are newly recommended for screening and of whom only 20% are up to date, the test showed 100% sensitivity for CRC and 94.8% specificity for ACN in the primary analysis.

"By enrolling a diverse, average-risk population and analyzing samples consecutively, the PREEMPT study mirrored real-world use," said Aaron Elliott, Ph.D., chief executive officer at Freenome. "The test showed strong performance in Stage I cancer and high-risk pre-cancers and among younger adults, compared to FDA-approved CRC blood tests. This highlights the potential of the Freenome test to expand adherence to CRC screening recommendations and detect cancer earlier."

PREEMPT CRC was conducted at more than 200 clinical sites using a hybrid recruitment strategy with the end goal of increasing trial accessibility and diversity. This approach made participation possible from every state in the continental U.S. More than 11% of participants identified as Black or African American, and over 11% as Hispanic or Latino.

"We need more tools that meet people where they are, which includes offering noninvasive screening options that are simple to complete," Dr. Shaukat added. "This test has the potential to increase screening uptake, especially among people who might otherwise delay or avoid screening."

To pursue its vision of personalized early cancer detection, Freenome developed a multiomics platform that analyzes genomic, epigenomic, and proteomic biomarkers to detect cancer-specific signals in the bloodstream, including those derived from circulating tumor DNA (ctDNA). The company's CRC screening blood test was built on this platform and applies an AI/ML-based model to detect specific methylation signatures in ctDNA at a base level. Designed for use with a standard blood draw, the test integrates into routine clinical workflows, leveraging Freenome's software.

The company is advancing the premarket approval submission for its CRC screening blood test to the FDA, with all modules expected to be completed in mid-2025. Freenome also continues to advance a test versioning strategy focused on assay and algorithm improvements to enhance CRC and APL detection, as well as pursue expansion into additional indications, including lung cancer.

The full manuscript is now available online in JAMA. To access the paper, visit https://jamanetwork.com/journals/jama/article-abstract/2834891.  

About PREEMPT CRC

PREEMPT CRC (NCT04369053) was a prospective, registrational clinical study designed to validate Freenome's blood test for the early detection of colorectal cancer (CRC) among average-risk adults. Initiated in 2020, the study was conducted at more than 200 sites and enrolled 48,995 asymptomatic, average-risk participants between the ages of 45 and 85 scheduled to undergo a screening colonoscopy. Freenome and the U.S. Food and Drug Administration agreed upon a predetermined cut-off date for the period most affected by the COVID-19 pandemic. The study analyzed the 27,010 participants who enrolled consecutively or after the predetermined cut-off date.

The study leveraged a novel hybrid model involving virtual and traditional recruitment methods to reach underserved communities and ensure a representative population. The decentralized recruitment strategy underscores Freenome's commitment to promoting equity and diversity in clinical studies, ensuring its tests are designed for everyone.

Freenome's partners in PREEMPT CRC included the Colorectal Cancer Alliance, Dia de la Mujer Latina, the Intercultural Center for Health Research and Wellness, and historically Black colleges and universities (HBCUs), including Morehouse School of Medicine. Freenome also worked with CVS Health Clinical Trial Services to help drive study enrollment through coordinated communication efforts targeting patients with already scheduled colonoscopies.

About Freenome

Freenome is breaking barriers to early cancer detection with a suite of blood tests built on its multiomics platform. The company recognizes that no single technology can identify every cancer due to the disease's inherent heterogeneity. Freenome's multimodal approach combines molecular biology and assays with computational biology, machine learning and multiple data types to tune into cancer's subtlest cues, even at the earliest stages of the disease.

With the convenience of a standard blood draw, Freenome aims to empower everyone to access recommended cancer screenings. The company is partnering with healthcare organizations and population health decision-makers to integrate its technology and software platform, making cancer detection easier and more accessible. Freenome is headquartered in Brisbane, California. Find out more at www.freenome.com and visit us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the PREEMPT CRC, the use of information from that study, and Freenome's plans and expectations regarding its FDA submission, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts, and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. The forward-looking statements in this press release are based on information available to Freenome as of the date hereof, and Freenome disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Freenome's views as of any date subsequent to the date of this press release.

References

1. Shaukat A, Burke CA, Chan AT, et al. Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer. JAMA. Published online June 2, 2025. doi: 10.1001/jama.2025.7515.

2. U.S. Food and Drug Administration. Summary of safety and effectiveness data [Guardant Shield]. Published July 26, 2024. Accessed May 27, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230009B.pdf

3. Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA: A Cancer J for Clinicians. 2023;73(3):233-254. doi:10.3322/caac.21772.

4. Piscitello A, Edwards DK. Estimating the screening-eligible population size, ages 45–74, at average risk to develop colorectal cancer in the United States. Cancer Prevention Research. 2020;13(5):443-448. doi:10.1158/1940-6207.CAPR-19-0527.

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SOURCE Freenome Holdings, Inc.