
Freenome develops blood-based cancer screening tests using multiomics and AI.
Freenome's screening approach combines multiple biological signals from a standard blood draw with artificial intelligence and machine learning rather than relying on a single detection technology. The company states that no single technology can identify every cancer, which motivates its multiomics design.
Large clinical studies support its programs, including PREEMPT CRC with more than 40,000 participants and the PROACT LUNG study. Regulatory milestones, including FDA approval of its colorectal screening test and Breakthrough Device Designation for its lung test, anchor its clinical evidence base.
Source: freenome.com
Blood-based cancer screening is positioned as a way to reach adults who do not complete guideline screening, and Freenome's tests are designed for that population. The company's colorectal test targets average-risk adults aged 45 and older who have not completed colonoscopy or stool-based screening.
Its lung test targets adults with significant smoking history who are not participating in recommended low-dose CT screening. Partnerships with Abbott for United States commercialization and Roche for development and commercialization outside the United States shape how the portfolio reaches those markets.
Source: freenome.com
Freenome commercializes its approved colorectal cancer screening test in the United States through a partnership with Abbott, which serves as the exclusive United States commercializer. The company also grants certain international testing rights to Roche.
Partnerships extend the platform's reach without building a direct commercial organization in every market. The United States arrangement covers the screening test approved in 2026.
Source: freenome.com
Freenome's SimpleScreen portfolio offers blood-based cancer screening tests built on a multiomics platform that reads circulating cell-free DNA and other biological signals from a standard blood draw. Its colorectal cancer screening test is FDA approved for average-risk adults aged 45 and older and is commercialized in the United States by Abbott.
The portfolio also includes an investigational blood-based lung cancer screening test for high-risk adults, which has received FDA Breakthrough Device Designation and remains in clinical development. Positive screening results are followed by colonoscopy for the colorectal test and by low-dose CT for the lung test.
Source: freenome.com