#United States #Brisbane #Colorectal Cancer #Blood Test #Freenome

Freenome's Revolutionary Step in Colorectal Cancer Detection

Freenome, a pioneering biotechnology company specializing in early cancer detection, recently announced the publication of significant results from its pivotal PREEMPT CRC study in JAMA. This study marks a crucial development in the fight against colorectal cancer through a groundbreaking blood-based screening test. The research involved an extensive cohort of nearly 49,000 individuals aged between 45 and 85, emphasizing its potential impact on improving early detection rates and access to screening.

Key Findings of the PREEMPT CRC Study

The PREEMPT CRC study represents the largest prospectively conducted examination of a blood-based screening test for colorectal cancer, including detailed analyses involving 48,995 average-risk adults. This comprehensive study's findings are vital as they met all primary efficacy goals while surpassing coverage requirements set forth by the Centers for Medicare and Medicaid Services (CMS), particularly regarding sensitivity and specificity.

The analysis revealed that among 27,010 participants who met the eligibility criteria, the test demonstrated:

• - Overall CRC sensitivity: 79.2%
• - Stage I sensitivity: 57.1%
• - Stage II sensitivity: 100%
• - Stage III sensitivity: 82.4%
• - Stage IV sensitivity: 100%
• - Specificity for Advanced Colorectal Neoplasia (ACN): 91.5%
• - Sensitivity for High-Grade Dysplasia and Carcinoma in Situ: 29.1%

These findings provide crucial insights, particularly concerning the potential for the test to identify colorectal cancer at earlier stages, which is vital for effective intervention and treatment.

Dr. Aasma Shaukat, a leading investigator in the study, highlights the profound implications these results hold for colorectal cancer screening across various demographics. Although there are clear guidelines for screening, many eligible individuals do not undergo testing due to barriers related to access, discomfort, or preparation. This study aims to address the issue, particularly demonstrating that for younger adults (ages 45-49), who are newly recommended for screening, the test achieved 100% sensitivity.

Expanding Access to Screening

Significantly, the PREEMPT CRC study followed a hybrid recruitment model designed to enhance accessibility and diversity. Conducted at more than 200 clinical locations, the research included participants from all over the continental United States, with over 11% identifying as Black or African American and an equal percentage as Hispanic or Latino. This effort underscores Freenome's commitment to ensuring that its cancer detection tools are applicable in real-world scenarios and cater to diverse populations.

Dr. Aaron Elliott, Freenome's CEO, emphasized the real-world applications of the study, stating that the design closely mimicked actual healthcare practices and indicated remarkable performance in both early-stage cancers and advanced precancerous lesions. The study results suggest that utilizing this screening test could significantly improve adherence to colorectal cancer screening guidelines and enhance the early detection of malignancies when they are most treatable.

Future Directions

Freenome is currently preparing for a premarket approval submission to the U.S. Food and Drug Administration (FDA) for this innovative colorectal cancer screening test with an expected completion by mid-2025. The organization is also consistently working on enhancing assay and algorithm performance to further improve detection rates for colorectal cancer as well as advanced precancerous lesions.

This evolution in colorectal cancer screening via blood testing could pave the way for similar innovations in detecting other types of cancer, with Freenome eyeing expansion into lung cancer screening among other indications.

As the full manuscript detailing the PREEMPT CRC study is now accessible in JAMA, it opens up channels for further discussion and analysis in the medical community regarding effective cancer screening methods. Freenome's mission to empower early cancer detection and provide accessible screening options to all is both commendable and vital in the evolving cancer care landscape.

To read the full study, visit JAMA Network.