Diagnostic innovation in oncology continues to outpace the European regulatory and reimbursement frameworks built to absorb it, a pattern visible across early detection, screening and the infrastructure meant to support both. Blood-based screening for colorectal cancer has moved from a theoretical alternative to stool- and endoscopy-based pathways to a commercially available option in the United States, and two companies advancing that category, Freenome and Guardant Health, published updated US performance and real-world data at the same conference, the American College of Gastroenterology (ACG)’s 2026 Annual Meeting. A separate development, NeoGenomics’ expanded digital pathology partnership, illustrates a related but distinct dynamic: the regulatory groundwork for AI-driven diagnostics in Europe can be in place well before the specific tests built to run on it. Taken together, these three developments outline where US diagnostic innovation is currently advancing fastest, and where Europe’s own regulatory and reimbursement pathways still have ground to cover.
Freenome reports sharper detection of precancerous colorectal lesions
Freenome’s updated SimpleScreen colorectal cancer (CRC) screening test detected 18.2% of advanced precancerous lesions (APLs), up from 13.7% for the first-generation version, in validation data presented as a late-breaking oral presentation at ACG 2026 Annual Meeting [1]. Detection of lesions with high-grade dysplasia specifically rose from 30.5% to 41.9%, while sensitivity for CRC itself held at 80.4% and specificity remained at 90% [1][2]. The figures are drawn from previously unevaluated samples within the 48,995-patient PREEMPT CRC registrational study, combined with the test’s original validation cohort, and extend a topline readout Freenome first disclosed in July 2026 [3]. Freenome’s own modelling analysis projects that the update would prevent an additional 9.5% of CRC cases and deaths over three-yearly screening of 100,000 average-risk adults aged 45 to 75, compared with the original version of the test [1].
Freenome’s first-generation SimpleScreen test received FDA approval in July 2026, and Abbott began commercialising it in the United States in late September under an exclusive agreement, giving the updated performance data a route into an existing US distribution channel rather than a standalone launch. No CE-marking or IVDR filing has been disclosed for the updated test, and Aasma Shaukat, the investigator who presented the late-breaking data, described blood-based tests as additive to colonoscopy and stool-based screening, not a replacement for either [2]. European payers assessing a future submission for a blood-based colorectal screening test are likely to expect comparative data against the faecal immunochemical test (FIT) benchmarks already embedded in national screening programmes, data this presentation does not include.
Guardant Health reports real-world adherence data for its Shield screening test
Guardant Health’s Shield blood test showed a 99% screening-adherence rate in a real-world implementation study across two rural South Carolina clinics, according to the company’s 15 October release tied to its ACG 2026 presentation [4]. In this study, a lifetime-modelling analysis projected 12 CRC deaths averted per 1,000 people screened with Shield, against 9 for multi-target stool DNA testing and 6 for FIT, as well as more than 90% real-world adherence across over 200,000 Shield tests performed to date, compared with a published range of 28-71% for CRC screening generally [4]. The release does not disclose the modelling study’s full methodology or assumptions, and the figures have not yet been corroborated by an independent source.
The comparison is US-only, and Guardant Health has not disclosed a European regulatory filing or launch plan for Shield alongside this data. For European market-access teams, the adherence and deaths-averted figures build a useful reference case for the argument that blood-based screening raises participation relative to stool-based alternatives, but comparable adherence or cost-effectiveness data for Shield within European screening pathways is not yet available, leaving the comparison without a direct European analogue for now.
NeoGenomics expands AI-powered digital pathology infrastructure already cleared for Europe
NeoGenomics expanded its partnership with Indica Labs on 15 October, adopting Indica’s HALO AP platform as vendor-neutral, cloud-based infrastructure for its digital pathology operations and for future AI-based diagnostic tools, including anticipated applications tied to the growing antibody-drug conjugate (ADC) treatment pipeline [5]. HALO AP is CE-marked under the In Vitro Diagnostic Regulation (IVDR) for in vitro diagnostic use in the EU, the UK and Switzerland, though it remains research-use-only and is not yet FDA-cleared in the US. NeoGenomics operates a CAP-accredited laboratory in Cambridge, England, though the release does not state whether that site will run on HALO AP, and no financial terms, deployment timeline or performance data were disclosed [5].
Unlike the two screening tests above, this is an infrastructure and readiness move rather than a new test or regulatory filing, and it is the one development here with a genuine European angle already in place. The underlying platform’s existing CE-IVDR marking across the EU, UK and Switzerland means the regulatory groundwork for European AI-pathology deployment already exists, even though NeoGenomics has not disclosed plans to extend the partnership beyond its Cambridge site.
Concluding remarks
The three developments covered here sit at different points on the same curve: Freenome and Guardant Health are refining the clinical and real-world performance case for blood-based CRC screening within an established US regulatory and commercial framework, with no corresponding European filing yet disclosed for either test, while NeoGenomics’ choice of an already CE-IVDR marked pathology platform shows that the regulatory infrastructure for AI-driven diagnostics in Europe can precede the specific tests built to use it. Whether, and on what timeline, a comparable pathway opens for blood-based CRC screening in Europe is likely to depend on how the IVDR framework ultimately treats screening assays that sit outside the companion-diagnostic category, a question that remains unresolved even as the underlying evidence, on both the clinical and infrastructure sides, continues to mature.
This analysis is drawn from Precision Oncology Consulting’s ongoing monitoring of precision oncology diagnostics, liquid biopsy, MRD and European market access. Subscribe to receive new analysis in your inbox – free, no spam, unsubscribe anytime.
References
- Freenome, “Freenome to Present New Validation Data for Next-Generation CRC Screening Test in Late-Breaking Oral Presentation at ACG 2026” (11 Oct 2026)
- HCPLive, “Updated SimpleScreen CRC Blood Test Improves Precancerous Lesion Detection” (14 Oct 2026)
- Freenome, “Freenome Reports Top-Line Readout of Updated SimpleScreen CRC Colorectal Cancer Screening Blood Test — Met All Primary and Secondary Endpoints” (9 Jul 2026)
- Guardant Health, “Guardant Health Shield Blood Test Demonstrates Leading Screening Adherence and CRC Deaths Averted Compared to Stool-Based Tests” (15 Oct 2026)
- NeoGenomics, “NeoGenomics Expands Indica Labs Partnership to Scale AI-Powered Digital Pathology” (15 Oct 2026)
