Precision Oncology Consulting | Published 28 October 2026
European access to new oncology diagnostics continues to depend less on regulatory clearance itself than on what happens after it: national reimbursement decisions, commercial build-out and the broader portfolio strategies of the companies involved. Colorectal cancer (CRC) screening illustrates the first of these dynamics directly, as an updated version of an established US stool-DNA test gains a formal route into European markets without yet securing the funding decisions that would make it broadly available. Elsewhere in precision oncology, the commercial infrastructure behind diagnostics, from licensed real-world data to testing portfolios, continues to shift through a parallel set of agreements and divestitures. Tempus AI’s expanded data-licensing arrangement with Bristol Myers Squibb and Myriad Genetics’ decision to sell its prenatal testing business both show diagnostics companies directing data assets and capital toward oncology. A fourth development, a firm shareholder vote date for Tempus’s pending acquisition of Personalis, moves forward a deal designed to bring Personalis’ ultra-sensitive, tumour-informed molecular residual disease (MRD) testing into Tempus’ precision oncology portfolio. Taken together, these developments span regulatory access, data commercialisation and company strategy, each carrying its own implications for how precision oncology diagnostics reach European patients and clinicians.
Abbott’s Cologuard Plus receives CE marking under the EU’s IVDR
Abbott’s Cologuard Plus, a non-invasive, stool-DNA-based test for colorectal cancer (CRC) screening, received CE marking under the EU’s In Vitro Diagnostic Regulation (IVDR) on 20 October, the company announced [1]. The clearance brings a test approved by the US Food and Drug Administration (FDA) in 2024 into the European market for the first time, with Abbott planning a phased rollout in “select European markets” and no specific country or launch date yet named [1][2]. In the pivotal BLUE-C study, which enrolled more than 20,000 participants in the US population, the updated test demonstrated 95% sensitivity for CRC detection at 94% specificity, and detected advanced precancerous lesions with 43% sensitivity (74% for lesions with high-grade dysplasia). Additionally, updated biomarkers and laboratory methods cut false-positive results by up to 40% relative to the original Cologuard test [1][2]. Abbott described the CE mark as “an important step” toward making the test available in Europe, while Jake Orville, senior vice-president of Abbott’s cancer diagnostics business, stressed that screening only works when people complete it [1]; Abbott’s Cancer Diagnostics segment, which now includes the Cologuard franchise following its March 2026 acquisition of Exact Sciences, reported $968 million in revenue for the third quarter of 2026, up 13.8% on a comparable basis [3].
CE marking establishes regulatory eligibility rather than guaranteed access: coverage will still depend on country-by-country health technology assessment (HTA) and reimbursement decisions that Abbott has not yet disclosed, each following its own evidentiary and procedural timeline. Organisations monitoring the rollout may find it useful to track which national screening programme is first to evaluate Cologuard Plus alongside existing faecal immunochemical test (FIT) pathways, since that decision is likely to set a reference point for later submissions in other European markets.
Tempus AI expands real-world data licensing agreement with Bristol Myers Squibb
Tempus AI announced an expanded, multi-year strategic collaboration with Bristol Myers Squibb (BMS) on 23 October, under which BMS licenses multimodal, de-identified real-world oncology data from Tempus through 2031 and becomes one of Tempus’s largest data licensors [4]. The agreement also gives BMS access to Tempus’s Lens Platform, an agentic artificial-intelligence (AI) environment with graphics-processing-unit (GPU) compute access, to train and run models for drug discovery, building on an existing relationship already applied to oncology and neuroscience trial design [4][5]. The press release did not include financial terms, but a same-day filing with the US Securities and Exchange Commission (SEC) shows that BMS will pay Tempus $137.5 million in fixed payments through 31 December 2031 for oncology data access, Lens software and related services [5].
Licensing arrangements of this kind do not themselves change European regulatory or reimbursement status, but the underlying real-world data assets increasingly feed the clinical and health-economic evidence that European HTA bodies request from sponsors when assessing new oncology therapies and companion diagnostics. Organisations building European evidence packages may want to monitor how data-licensing relationships such as this one shape the real-world datasets later cited in regulatory and reimbursement submissions.
Myriad Genetics sells its prenatal testing business to Labcorp
Myriad Genetics announced a definitive agreement on 20 October to sell its Prenatal Health testing business to Labcorp for $210 million in cash plus inventory value at closing [6]. Myriad described the sale as the outcome of a “disciplined strategic review” intended to sharpen its portfolio, adding that the proceeds strengthen its balance sheet for continued investment in strategic priorities tied to “the cancer care continuum”; the company said it would comment further on the transaction during its 4 November 2026 earnings call [6]. The transaction is expected to close by early 2027, subject to regulatory clearance and customary closing conditions [6].
No European detail was disclosed alongside the announcement, and the divestiture does not itself introduce any new oncology-testing capability; its relevance for European market-access planning lies in the signal it sends about where Myriad intends to commit capital next: its cancer-focused portfolio rather than reproductive health.
Personalis shareholders set a date to vote on the Tempus acquisition
Personalis filed a definitive merger proxy statement on 21 October confirming that its shareholders will vote on Tempus AI’s pending $1.5 billion acquisition of the company at a virtual special meeting on 30 November 2026, with a record date of 15 October [7][8]. The outside date for completing the transaction is 20 April 2027, extendable under specified conditions to October 2027 and, in some circumstances, April 2028; MSD (Merck Sharp & Dohme), holding roughly 13% of Personalis shares, and Tempus itself, holding roughly 12%, have each agreed to vote in favour [7].
A firm vote date moves the deal a step closer to bringing Personalis’ NeXT Personal MRD test, which Tempus has commercialised since the companies’ partnership began in November 2023, fully into Tempus’ portfolio. Tempus has said the acquisition extends its support for patients from diagnosis and treatment selection through to recurrence and monitoring, and describes MRD as a $20 billion market opportunity [9]. European customers and partners of either organisation may want to confirm how existing contracts, data-sharing terms or distribution arrangements for MRD testing would be affected should the acquisition close on its current timeline.
Concluding remarks
Taken together, these four developments touch separate levers of how precision oncology diagnostics reach European patients and the organisations that pay for them: regulatory clearance, data commercialisation and corporate portfolio strategy. Abbott’s newly CE-marked Cologuard Plus opens a regulatory route to CRC screening in Europe with a stool-DNA test, a different technology from the blood-based screening options covered in an earlier analysis on this blog. Tempus AI’s expanded data-licensing relationship with Bristol Myers Squibb and Myriad Genetics’ divestiture of its prenatal business both illustrate diagnostics companies continuing to reallocate data assets and capital toward oncology specifically, while the newly fixed Personalis shareholder vote date moves Tempus closer to bringing ultra-sensitive MRD testing into its precision oncology portfolio. Across all four, the regulatory or corporate milestone itself typically arrives well before the reimbursement, data-sharing or integration decisions that ultimately determine access for European patients and clinicians.
References
- Abbott / PRNewswire, “Abbott’s Cologuard Plus Receives CE Mark for Colorectal Cancer Screening in Europe” (20 Oct 2026)
- MassDevice, “Abbott’s Cologuard Plus screening test receives CE Mark, Europe approval” (20 Oct 2026)
- Abbott, Q3 2026 results, SEC Form 8-K (21 Oct 2026)
- Tempus AI, “Tempus Expands Strategic Collaboration with Bristol Myers Squibb” (23 Oct 2026)
- Tempus AI, SEC Form 8-K filing index (23 Oct 2026)
- Myriad Genetics, investor news release, Prenatal Health divestiture to Labcorp (20 Oct 2026)
- Personalis, Form DEFM14A, definitive merger proxy statement (21 Oct 2026)
- Tempus / Personalis merger proxy, SEC Form 424B3 (21 Oct 2026)
- Tempus AI, “Tempus to Acquire Personalis, More Tightly Integrating Molecular Residual Disease (MRD) into Its AI-Enabled Precision Oncology Platform” (20 Jul 2026)
