Freenome's Next-Generation Colorectal Cancer Blood Test Achieves Clinical Success, Triggering a $70 Million Milestone Payment from Abbott
Enhanced Performance and Clinical Significance of the Next-Generation Blood Diagnostic Technology, SimpleScreen CRC
Freenome has released pivotal clinical data for its next-generation colorectal cancer (CRC) blood screening test, 'SimpleScreen CRC.' This updated version demonstrates improved performance compared to the first-generation test, achieving a sensitivity of 80.4% and a specificity of 90% in detecting colorectal cancer. The sensitivity for detecting advanced precancerous lesions (APL), a key factor in early detection, has also significantly improved from 12.5% to 18.2%, further validating its value in early diagnosis. This represents a strong non-invasive alternative to invasive colonoscopies or inconvenient stool tests, potentially revolutionizing patient compliance and significantly improving early survival rates for colorectal cancer.
Strengthened Commercialization Partnership with Abbott and $70 Million Milestone Trigger
This clinical success reinforces the commercialization partnership between Freenome and Abbott Laboratories (ABT). According to the commercialization agreement signed on August 2025, the release of this pivotal data triggers a $70 million milestone payment. This milestone will be paid upon completion of the final approval from the U.S. Food and Drug Administration (FDA) and the technology transfer. While the originally agreed-upon maximum milestone of $100 million was based on achieving an APL sensitivity of 19% and a CRC sensitivity of 83%, the actual figures were slightly lower, resulting in a $70 million payment. However, this does not diminish its importance as a key driver for significantly strengthening Abbott's diagnostics portfolio.
Shifting Market Dynamics with Guardant Health and Exact Sciences
SimpleScreen CRC directly competes with Guardant Health's (GH) approved blood-based test, 'Shield,' and Exact Sciences' (EXAS) 'Cologuard,' which dominates the stool DNA multitarget stool DNA test market. Guardant Health's Shield, which received FDA approval in July 2024, has a CRC sensitivity of 83% and an APL sensitivity of 13%. In contrast, Freenome's next-generation test demonstrates a CRC sensitivity of 80.4%, slightly lower, but an APL sensitivity of 18.2%, proving its screening capabilities at the pre-cancer stage. Although it does not yet match Cologuard's higher APL sensitivity (42-43%) achieved in 2025 with annual revenues of $2.53 billion, Freenome has established a unique and superior performance among blood-based liquid biopsy tests.
FDA Approval Roadmap and Future Prospects for the Colorectal Cancer Screening Market
Freenome has already submitted a premarket approval (PMA) application for the first-generation SimpleScreen CRC test in August 2025 and expects to receive final regulatory approval by mid-2026. The company plans to accelerate its market entry by subsequently submitting a supplemental PMA for the next-generation version once the first generation receives approval. The U.S. colorectal cancer screening market is currently estimated at $11.2 billion and is expected to grow rapidly due to the aging population and the lowering of screening age to 45. The blood-based liquid biopsy market also has the potential to capture a significant share, worth billions of dollars. With Abbott's strong global distribution network and marketing capabilities, significant market share shifts can be expected after regulatory approval.
Freenome's next-generation SimpleScreen CRC clinical results achieved a colorectal cancer sensitivity of 80.4% and an advanced precancerous lesion (APL) sensitivity of 18.2%, surpassing the APL sensitivity of 13% of Guardant Health's Shield. This clinical success triggered a $70 million milestone payment under the commercialization agreement with partner Abbott, to be finalized upon FDA PMA approval and technology transfer, expected by mid-2026. This suggests that blood-based liquid biopsies can penetrate the $11.2 billion U.S. colorectal cancer screening market, currently dominated by Exact Sciences' Cologuard, which generates $2.53 billion in annual revenue. In the short term, market penetration through Abbott's sales network is expected after FDA approval, and in the medium to long term, blood-based diagnostics are expected to be included as a guideline recommendation. This achievement demonstrates the clinical potential of liquid biopsies to effectively diagnose not only early screening but also pre-cancerous stages, including high-grade dysplasia (HGD) with a sensitivity of 41.9%.
Source: BioPharma Dive (rss)