Key points
- Navignostics built a fully digital cancer diagnostics lab from the outset, bypassing the paper-to-digital transition that burdens most clinical labs.
- Lionetti said the company’s spatial single-cell proteomics platform analyzes 40-plus proteins per tissue slide and targets a sub-48-hour turnaround from sample intake to clinical report.
- By treating lab informatics as a core product rather than an IT tool, the company aimed for end-to-end traceability across lab execution, data capture and reporting.
- Real-time API integration connects wet lab workflows directly to machine learning pipelines, supporting automated outputs with a consistent, auditable data trail.
At SapioCon 2026, Federico Lionetti, software systems lead at Navignostics, laid out a deceptively simple overview of what the company has built.
“We’ve built the kind of lab that big pharma is still trying to digitize. Starting fresh and starting digital made that possible.”
It’s a pointed claim, but the challenge he described is familiar.
A standard method for analyzing proteins on tumor tissue still relies on narrow measurements and stepwise manual work. Lionetti argued that this bottleneck limits not only throughput but also the clinical usefulness of diagnostics, constraining decisions to what labs can measure and return quickly enough to inform treatment selection.
Navignostics was built to change that.
A diagnostic gap with a technical answer
Navignostics’ spatial single-cell proteomics platform analyzes more than 40 proteins on a single standard pathology slide at single-cell resolution, Lionetti said. That level of detail, he argued, allows clinicians to map the tumor microenvironment well enough to support targeted therapy decisions rather than defaulting to generalized paths. Navignostics targets a sub-48-hour turnaround from sample intake to a treatment-informing report, he added.
Lionetti described building Navignostics’ digital backbone on Sapio Sciences’ unified platform so lab execution, data capture and clinical reporting could run off the same governed record rather than being stitched together after the fact.
“We didn’t transition from paper to digital. We started digital from day one.”
That meant treating the informatics backbone not as an IT layer but as a core product. Lionetti described building Navignostics’ digital backbone on Sapio Sciences’ unified platform so lab execution, data capture and clinical reporting could run off the same governed record rather than being stitched together after the fact.
Three things that changed
Restructuring around a single data model did more than improve efficiency. It changed what the lab could trust, reuse, and act on, because the wet lab, data pipeline, and clinical output no longer needed reconciling afterward.
First, the lab gained end-to-end continuity. Samples, reagents and instruments are tracked from intake through to the final report within the same environment, reducing the reconciliation work between the bench, the data team and the reporting layer.
Second, quality control became a workflow mechanism rather than a manual checkpoint. Lionetti described QC outcomes triggering conditional routing, with samples moving forward when they meet requirements and exceptions flagged when they do not. The intent is to reduce points where transcription or workarounds introduce variability, particularly in processes where consistency is a clinical and regulatory requirement.
Third, instrument output was designed to flow directly into machine learning pipelines. When a run completes, data moves via API into downstream analysis and reporting rather than being exported and rebuilt later. Lionetti also described instrument management living alongside the workflow, including approved equipment lists, maintenance records, qualification logs and issue tracking, so operational status and analytical outputs do not have to be reconciled as separate worlds.
Aligning the people behind the platform
The infrastructure was one challenge. Aligning the teams behind it was another. Wet lab operators, data scientists, QA personnel and software engineers each bring different constraints. Lionetti said he tackled this through structured cross-functional workshops, not to build consensus for its own sake, but to make sure each team understood what the platform needed to do for the others.
“The LIMS is the foundation of our lab, not just another tool,”
That framing mattered because it changed how different functions related to the system and to each other.
What a digital-native lab enables
Lionetti described Navignostics as ISO 13485-certified and built to scale without needing to be rebuilt. He said the company is expanding into areas including temperature monitoring and supplier management, with an AI-powered patient-matching engine on the roadmap that would link new cases to previously successful treatment profiles.
The distinction between “starting digital” and “going digital” is worth holding onto. Organizations undertaking digital transformation inherit constraints: legacy data structures, disconnected tools and accumulated workarounds. Starting from scratch changes what the foundation can support, and it changes how quickly teams can standardize, trace and reuse what they learn.
Federico Lionetti presented at SapioCon 2026. Navignostics runs on Sapio Sciences’ unified lab informatics platform, which connects their LIMS, ELN, and clinical reporting into a single data model.
