Precision diagnostics moved decisively from theoretical promise to tangible clinical impact in 2025.
This was the year when liquid biopsy programmes reached national scale, multi-omics integration became realistic rather than aspirational, and AI risk-prediction models demonstrated the ability to forecast disease years before symptoms.
For leaders across healthcare, diagnostics, and biopharma, 2025 marked a shift toward a more proactive, data-driven model of precision care – and set the stage for a transformative 2026.
2025: What Actually Changed?
1. Liquid biopsy stepped into mainstream care
One of the biggest milestones came from the UK, where NHS England launched a national liquid biopsy programme to accelerate access to targeted therapy for lung and breast cancer. This rollout – described as a world-first – cut time-to-treatment by up to two weeks, reduced the need for invasive tissue sampling, and signalled that blood-based diagnostics are ready for real-world pathways, not just trials.
Meanwhile, multi-cancer early detection (MCED) testing continued to mature. Reviews in 2025 underscored its potential to expand screening beyond the handful of cancers for which structured programmes exist today. The UK Galleri study added further momentum, demonstrating around 84% accuracy in detecting more than 50 cancer types from a single blood sample, often identifying cancers missed by traditional diagnostics.
These developments collectively signalled that blood is becoming the new biopsy, reshaping expectations for early detection and targeted intervention.
2. Companion diagnostics became the backbone of precision oncology
2025 also reinforced how essential companion diagnostics (CDx) have become for targeted therapy decision-making. The FDA’s list of approved CDx products continued to expand, reflecting the growing number of therapies that require precise genomic or molecular information before use.
Guardant360 CDx reached its sixth FDA indication, supporting treatment selection for ESR1-mutated breast cancer, while Foundation Medicine surpassed 55 approved indications across its genomic profiling platforms.
In practice, this means precision therapy and precision diagnostics are no longer separate concepts – they are two halves of the same clinical decision.
3. Multi-omics and spatial biology finally gained traction
A notable shift in 2025 was the move from single-modality tests to multi-omics signatures that combine genomics, transcriptomics, proteomics, metabolomics and imaging. European initiatives such as EP PerMed highlighted not just scientific progress, but the increasing need to integrate multi-omics into clinical-grade biomarker discovery and patient stratification.
Multi-omics insights accelerated understanding of complex conditions including neurological disorders, cardiovascular disease, and immune-mediated illnesses – areas where traditional biomarkers have repeatedly fallen short. Spatial biology, too, emerged as a key tool for understanding tumour microenvironments, supporting more refined therapy decisions.
4. AI moved from assistive to predictive
Perhaps the most profound conceptual shift came from AI. Models such as Delphi-2M, trained on hundreds of thousands of UK Biobank records and validated on 2 million Danish patient records, showed that AI can forecast susceptibility to more than 1,000 diseases well in advance – sometimes by decades.
At the same time, AI continued to enhance digital pathology, radiology, and spatial biology, helping clinicians stratify patients more effectively and reduce diagnostic uncertainty. The narrative surrounding AI changed: it’s no longer just about accelerating workflows – it’s about anticipating disease before it manifests.
5. Personalised diagnostics reached the consumer
Consumer adoption accelerated as well. Viome surpassed 500,000 sold at-home kits, leveraging RNA-based multi-omics and AI interpretation to offer personalised health, nutrition, and early-risk insights (including for oral cancer). While debates remain around regulation and clinical validity, the trend is clear: personalised diagnostics are moving into daily life, not just clinical settings.
What 2025 Taught the Industry
Despite varied developments, several lessons stood out:
- Time-to-treatment can be dramatically reduced with liquid biopsy and NGS-based diagnostics.
- Biomarker-driven trial design is becoming standard, enabling more efficient and targeted studies.
- Data strategy is no longer optional – multi-omics, imaging and real-world evidence require robust, interoperable infrastructure.
In short, precision diagnostics isn’t just “future healthcare” – it is reshaping operational, clinical, and regulatory norms right now.
How Organisations Should Prepare
- Healthcare providers should identify where liquid biopsy could reduce diagnostic delays, invest in data infrastructure, and support clinician education in genomics and AI-enabled risk tools.
- Biopharma must treat the drug, diagnostic, and data strategy as a single design problem – not separate functions – and use multi-omics to optimise trial design from the start.
- Diagnostics and health-tech companies should focus on interoperability, workflow integration, and report clarity as key differentiators.
- Payers and policymakers will need reimbursement models that reward early detection and insist on equitable deployment of new tools.
2025 proved that precision diagnostics is no longer an emerging trend – it’s a present-day reality transforming how diseases are detected, predicted, and treated. In 2026, the organisations that gain the most ground will be those that move beyond pilots and begin operationalising precision medicine at scale.