Guardant Health, Inc. and Fondazione Policlinico Universitario Agostino Gemelli IRCCS have launched FPG 360, an in-house liquid biopsy testing service at the Gemelli hospital campus in Rome, Italy, based on the Guardant360 CDx platform. Announced on December 9, 2025, the collaboration brings Guardant Health’s certified liquid biopsy diagnostics directly into a leading European cancer hospital, bypassing international sample shipping requirements and embedding precision oncology into day-to-day care.

The initiative marks one of the first dedicated hospital-based liquid biopsy labs in Italy and positions Policlinico Gemelli among a small but growing cohort of European cancer centers equipped for in-situ genomic profiling. The launch expands Guardant Health’s footprint in Europe following similar partnerships with Val d’Hebron Institute of Oncology in Barcelona and The Royal Marsden Hospital in London, signaling a move toward deeper integration with public research hospitals.

What Guardant’s Italy partnership reveals about CGP localization in Europe

Despite the availability of pan-cancer liquid biopsy assays across much of the European Union, real-world access remains limited by logistical and reimbursement barriers. By enabling on-site testing, the Gemelli–Guardant partnership removes a major bottleneck in delivering timely comprehensive genomic profiling, particularly for solid tumor patients who are either ineligible for tissue biopsy or urgently need biomarker-informed therapy decisions.

Italy, with approximately 400,000 new cancer cases diagnosed annually, has lagged behind countries like Germany and the Netherlands in routine implementation of CGP in hospital settings. The introduction of the Guardant360 CDx platform within the Gemelli ecosystem has the potential to shift that dynamic. It avoids shipping delays and preserves sample integrity, which is especially relevant in metastatic or refractory cancer cases where therapeutic windows are short and response rates are closely tied to biomarker matching.

Clinicians in Italy may also benefit from broader education and exposure to next-generation sequencing data interpretation, which has been a barrier to uptake in decentralized hospital systems. The operationalization of FPG 360 in a clinical and research setting could allow Italian oncology teams to gain fluency in genomic data use without relying on outsourced expertise, ultimately strengthening national capacity for precision cancer care.

How in-house liquid biopsy changes clinical trial logistics and recruitment

The Gemelli facility plays a dual role as a care provider and a research institute, treating over 50,000 cancer patients each year and hosting a large volume of early- and late-stage clinical trials. The ability to perform blood-based genomic profiling on-site is expected to streamline patient screening for trial eligibility, reduce time to enrollment, and improve cohort stratification.

In rare mutation-driven or biomarker-enriched trials, especially in tumor-agnostic indications, rapid identification of candidates is crucial. Decentralized access to Guardant360 CDx at the point of care could reduce screen failures and unlock trial participation opportunities for patients historically excluded due to the absence of rapid testing infrastructure. This is especially true in lung, breast, and gastrointestinal cancers, where Guardant Health’s assay is already used globally to guide enrollment in targeted therapy studies.

From an institutional standpoint, the ability to link longitudinal blood-based sequencing data with existing electronic health records and trial metadata could enhance the value of real-world evidence generated at Gemelli. Industry observers suggest this model aligns with the European Union’s cancer policy goals, which emphasize reducing disparities in access to innovative diagnostics and improving data interoperability across member states.

Why Guardant’s embedded diagnostics model may matter more than commercial scale

Unlike in the United States, where Guardant Health’s liquid biopsy test is available through national distribution networks and commercial reference labs, the European model is being shaped through site-specific partnerships. This approach has allowed Guardant Health to navigate the fragmented procurement systems and payer environments typical of EU member countries.

Rather than targeting broad uptake through private labs, Guardant Health has opted to build strategic relationships with research-intensive public hospitals capable of adopting and adapting its technology in-house. These partnerships are proving to be mutually reinforcing: the institutions gain cutting-edge diagnostics infrastructure, while Guardant Health gains localized operational proof points that could later inform broader reimbursement negotiations or regulatory engagement.

At Policlinico Gemelli, the move also reflects a commitment to strengthen national genomic medicine capacity rather than relying solely on international diagnostic supply chains. The hospital’s designation as an IRCCS, or Scientific Institute for Hospitalization and Care, along with its Joint Commission International accreditation and recognition as Italy’s top-ranked hospital, makes it a logical site for this kind of advanced deployment.

What barriers still remain for broader EU adoption of in-house CGP

Although the Italian launch is a milestone, challenges remain in expanding this model. Reimbursement for liquid biopsy testing varies significantly across the European Union, with many national health systems yet to formalize payments for CGP in metastatic cancer care. Additionally, staff training, infrastructure readiness, and standardization of reporting remain key obstacles to scale.

Another open question is how data from assays like Guardant360 CDx will be integrated into national cancer registries and used to inform population-level outcomes research. Without clear interoperability standards, many genomic testing initiatives risk becoming siloed within individual institutions rather than contributing to broader public health insights.

Furthermore, the presence of in-house CGP capabilities does not automatically translate to clinical utility unless oncologists are trained and encouraged to incorporate those insights into treatment planning. Cultural inertia and variation in biomarker literacy among clinicians continue to limit the full potential of precision oncology in practice. That said, initiatives like FPG 360 may serve as important catalysts for that cultural shift by embedding molecular insights into the heart of the hospital.

What to watch next as Guardant’s European footprint expands

The partnership at Policlinico Gemelli is part of a broader strategy that could define how liquid biopsy becomes standard in EU-based cancer care. As additional hospitals explore embedding assays like Guardant360 CDx into their workflows, industry analysts will be watching closely to see if this improves time-to-treatment, trial matching rates, and ultimately, patient outcomes.

More broadly, this development raises the question of whether pan-European cancer strategies should move toward encouraging local testing capabilities in national cancer centers as opposed to continuing to rely on centralized testing hubs. The policy implications could be far-reaching, especially as health ministries grapple with balancing cost-containment against innovation adoption.

If the Italian model proves clinically and economically viable, it could create a replicable template for similar public-private partnerships in France, Germany, and the Nordic countries. Success will likely depend on continued demonstration of the clinical value of rapid, decentralized genomic profiling and Guardant Health’s ability to align its business model with the public funding structures that dominate European healthcare.

The Gemelli partnership may not just be another deployment of a platform technology—it could be a foundational shift in how Europe approaches access to personalized cancer diagnostics.

  biomarker testing, cancer diagnostics, clinical trials, genomic profiling, Guardant Health, Guardant360 CDx, Italian cancer care, IVDR, liquid biopsy, Policlinico Gemelli, precision oncology