Freenome Announces Topline Results for PREEMPT CRC® to Validate the First Version of its Blood-Based Test for the Early Detection of Colorectal Cancer

– Study met all primary endpoints, including 79.2% sensitivity for colorectal cancer (CRC) and 91.5% specificity for non-advanced colorectal neoplasia –

– PREEMPT CRC, the largest study of a blood-based test for CRC, enrolled 48,995 participants, which reflects the real-world diversity of average-risk adults in the U.S. –

– As part of its planned test versioning strategy, the company will continue to optimize for CRC sensitivity and advanced adenoma (AA) detection in 2024 to meet guideline and policy milestones –

SOUTH SAN FRANCISCO, Calif., April 2, 2024 /PRNewswire/ -- Freenome, a biotechnology company pioneering an early cancer detection platform, today announced topline results from PREEMPT CRC, a prospective, registrational clinical study to validate its blood-based test for the early detection of colorectal cancer (CRC) among average-risk adults.

In a prespecified analysis, the Freenome blood test for CRC screening demonstrated 79.2% sensitivity in detecting colorectal cancer (Stage I: 57.1%, Stage II: 100%, Stage III: 82.4%, Stage IV: 100%) with 91.5% specificity for non-advanced colorectal neoplasia. The test also showed 12.5% sensitivity in detecting advanced adenomas (AA), with a sensitivity of 29% for AAs with high-grade dysplasia, also referred to as Stage 0. All endpoints were powered at 96% or greater.

When specificity was adjusted to the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) cut-off of 90%, there was a corresponding increase in the sensitivity for AA (14.8%) while maintaining CRC sensitivity. With the addition of proteins, an improved sensitivity for both AA (16.4%) and CRC (80.5%) at the 90% cut-off was observed. Additional study findings will be presented at a future 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,” said Lance Baldo, M.D., chief medical officer at Freenome. “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.”

PREEMPT CRC was a prospective, registrational study designed to validate the Freenome blood test for CRC screening. Conducted at more than 200 sites, the study enrolled 48,995 asymptomatic, average-risk adults between the ages of 45 and 85 scheduled to undergo a screening colonoscopy. The results were based on data from the 27,010 eligible participants who enrolled consecutively in the study after a predetermined cut-off date. The retained samples from these participants, along with samples from over 16,000 additional participants not utilized in the present analysis, remain available to support future test improvements.

The study leveraged a hybrid model involving virtual and traditional recruitment methods to reach underserved communities and ensure a representative population that includes people from all 48 states in the continental U.S. In addition, real-world data (RWD) collection through tokenization was integrated into the trial to complement the molecular data with longitudinal clinical outcomes that can be applied to CRC and other early cancer detection applications as part of the company’s platform and test versioning roadmap.

“While physicians have screening tools available for colorectal cancer, the associated inconvenience and discomfort of these methods deter many from getting recommended screenings,” said Aasma Shaukat, M.D., M.P.H., professor of medicine at the NYU Grossman School of Medicine and a principal investigator for the PREEMPT CRC study. “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.”

“In the PREEMPT CRC study, we brought communities together to confront a common enemy – cancer,” said Mike Nolan, chief executive officer at Freenome. “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.”

About PREEMPT CRC
PREEMPT CRC (NCT04369053) was a prospective, registrational clinical study 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. Of the 48,995 participants enrolled, 27,010 were evaluated.

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 Colorectal Cancer
Though colorectal cancer (CRC) is curable if detected early, sub-optimal screening rates mean CRC is often detected too late for successful treatment, making it the second cause of cancer deaths in the U.S.² Nearly twice as many people under the age of 55 are diagnosed with CRC than a decade ago, and more people are dying from the disease each year.³ In response, the U.S. Preventive Services Task Force lowered the screening guidelines for average-risk adults from 50 to 45 years old.⁴

Following screening guidelines can improve detection rates, and catching CRC early can lead to better outcomes.⁴ Despite the effectiveness of screenings in reducing CRC mortality, only 59% of U.S. adults adhere to screening guidelines.⁵ Recent data show that providing a blood test as a screening option to individuals who previously declined a colonoscopy or stool test increased screening rates.⁶

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 inherent heterogeneity of the disease. 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 South San Francisco, 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 topline results from PREEMPT CRC, the use of information from such study, and Freenome’s plans and expectations regarding future versions of PREEMPT CRC, 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. ^{Xi & Xu. Transl Oncol. 2021;14(10):101174}
2. ^{American Cancer Society. How Common Is Colorectal Cancer? (2023). Cancer.org.}
3. ^{American Cancer Society Colorectal Cancer Statistics, 2023}
4. ^{U.S. Preventive Services Task Force. Colorectal Cancer: Screening (2023) https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening}
5. ^{Colorectal cancer statistics, 2023. Siegel RL et al. CA: A Cancer J for Clinicians. 2023. doi: 10.3322/caac.21772}
6. ^{Liang, Peter S. et al. “Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial.” Clinical Gastroenterology and Hepatology. April 2023}

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SOURCE Freenome Holdings, Inc.