Navignostics
Navignostics is a Swiss laboratory service that maps up to 50 proteins in a single tumor tissue section using spatial single-cell proteomics, returning a PDF report that helps oncologists and drug developers choose targeted cancer treatments.
What is Navignostics?
Navignostics is a Swiss cancer diagnostics company, spun out of Bernd Bodenmiller's laboratory at the University of Zurich, with its laboratory and headquarters in Horgen near Zurich. It does not sell software: it operates a laboratory service built on spatial single-cell proteomics.
The workflow starts with an ordinary formalin-fixed, paraffin-embedded tumor section on a standard pathology slide, sent in by regular mail courier. Navignostics stains it with panels of up to 50 metal-labeled antibodies, then reads the slide on an imaging mass cytometry system that ablates the tissue with a laser and measures the metal weights by time of flight, in a single step. The result is a high-resolution digital image of the tumor's molecular composition. Proprietary automated computational workflows turn that image into quantified single-cell protein expression, cell types, cellular interactions and multicellular assemblies. The company's seed-round announcement describes the layer above this data as artificial intelligence driven software, and the published team includes a machine learning engineer, a computational manager, data scientists and software engineers.
The deliverable is a customizable electronic report in PDF format, and it serves two audiences. For clinicians, it shows which proteins and drug targets are present on which cells and where, information that standard immunohistochemistry struggles to supply from scarce tissue because it needs a separate section per marker, and that genomic tests indicate only indirectly. For drug developers and trial sponsors, the same analysis supports patient stratification, biomarker discovery and companion diagnostic development; the company notes that more than 90% of clinical trials fail at a late stage because the drug helped too small a segment of the cohort.
Two limits come from Navignostics itself. The analysis is Research Use Only and is not approved as a clinical diagnostic test, with studies supporting CE-IVD submissions still under way. And access runs through specific research programs at partner institutions in Switzerland and Europe, currently most active in lung, colorectal, melanoma and breast cancer. The company holds ISO 13485 certification, publishes the certificate, and states plainly that it neither prescribes treatments nor makes clinical decisions.
What it does
- Detect up to 50 proteins simultaneously in a single FFPE tumor section, at subcellular resolution
- Identify the cell types present, from tumor cells to the surrounding immune cells
- Map where those cells sit and how they interact within the tumor microenvironment
- Quantify single-cell protein expression, cell interactions and multicellular assemblies through automated computational workflows
- Produce a customizable PDF report describing the disease mechanisms at work
- Surface direct drug targets relevant to targeted therapies and immunotherapies
- Identify signatures and biomarkers that preselect likely responders for a clinical trial
When to use Navignostics / When not to
A quick filter to help you decide if Navignostics is the right fit.
When to use Navignostics
- Oncologists treating solid tumors who want protein-level evidence before choosing a targeted therapy or an immunotherapy
- Pathologists and molecular pathology institutes adding a spatial protein layer to conventional histology
- Clinical researchers and trial sponsors who must preselect the patient cohort most likely to respond
- Oncology drug developers working on biomarker discovery and companion diagnostics
- Translational research teams in university hospitals collaborating through partner research programs
When not to use Navignostics
- Patients acting on their own: the analysis can only be initiated by a treating oncologist inside a research program
- Clinicians who need an approved, reimbursable diagnostic test, since the analysis is Research Use Only and is not covered by health insurance
- Teams looking for software, an API or a mobile app, as Navignostics ships nothing to install or integrate
- Organizations outside the partner research programs currently running in Switzerland and Europe
- Buyers who need a published price or a committed turnaround time, neither of which appears anywhere on the site
How to use Navignostics
A typical end-to-end flow, from setup to results.
- Get in touch through the contact form on the About us page, by phone, or at the general address published in the imprint
- Establish access: as a clinician, connect with one of the partner research programs running in Switzerland and Europe
- As a patient, ask your treating oncologist to approach Navignostics or a partner institution, since the analysis cannot be ordered directly
- Have the pathology team confirm that enough tumor material remains from the existing biopsy or surgical specimen
- Send one FFPE tissue section on a standard pathology slide by regular mail courier; in most cases no new biopsy is required
- Navignostics measures and analyzes the sample on its imaging mass cytometry system
- Receive the electronic PDF report, addressed to the treating oncologist or pathologist
- Read the findings alongside the rest of the clinical picture, as they are not a clinical recommendation on their own
- As a patient, request a copy of the report through your clinical team
- As a trial sponsor, agree the scope of the collaboration: early translational research, biomarker discovery or a clinical trial
Pros & Cons
Pros
- One tissue section is enough, where standard immunohistochemistry needs a separate section per marker
- Direct protein-level evidence on drug targets, rather than the indirect indication genomic tests give
- Adds the spatial dimension: where cells sit and how they interact, not only what is present
- Backed by more than a decade of translational and clinical research, with company co-authors on papers in Nature, Cell, Nature Methods and Cancer Cell
- ISO 13485 certified quality system, with the certificate published rather than merely claimed
- No new biopsy needed in most cases, and nothing to install or integrate on the customer side
- Institutionally solid: a University of Zurich spin-off funded by Bruker, Zürcher Kantonalbank, Ventura Biomed, the UZH Life Science Fund and Think.Health
Cons
- Research Use Only: not approved as a clinical diagnostic test, and the company declines to forecast when that will change
- Access is limited to research programs at partner institutions in Switzerland and Europe
- No price is published anywhere, and there is no pricing page, no plan and no trial
- Not reimbursed by health insurance, so costs typically fall to research funding
- No turnaround time is published, only a statement that it depends on the analysis and current capacity
- No terms and conditions, no data processing agreement and no named subprocessor list are available online
- Solid tumors only, with activity concentrated on four indications, and some analyses return inconclusive results
Pricing & Plans
Navignostics publishes no prices. There is no pricing page, no list of plans, no permanent free plan and no free trial; probing the site confirms that no pricing page exists. Access is arranged by contacting the company, the recurring calls to action being to get in touch, to become an early-access partner, or to discuss speeding up a clinical trial. The patient FAQ states that analyses are currently conducted within research programs, are not reimbursed through health insurance, and that costs are typically covered by research funding. Pricing should therefore be treated as quotation-based.
Data, GDPR & hosting
A consolidated view of how Navignostics handles your data.
GDPR overview
The Privacy Notice, in force since 13 December 2023, states that it is aligned with both the EU GDPR and the Swiss FADP, while adding that whether and how far either applies depends on the individual case. Concrete references are present: Article 6(1)(a), (b), (c) and (f) are cited as legal bases, transfers to countries without adequate protection rely on the European Commission's revised Standard Contractual Clauses (Decision 2021/914), and Section 10 states that no automated individual decision-making is normally carried out. The patient page adds that data is handled under the revised FADP and, where applicable, the GDPR. Two gaps stand out: no EU representative is designated under Article 27, and no data protection officer is named, requests going to a generic address.
Who owns the data?
Navignostics publishes no terms and conditions, so ownership of the analysis data and of the resulting report is never contractually stated. The only binding document online is the Privacy Notice, which names Navignostics AG, Tödistrasse 46a, 8810 Horgen, as the controller of personal data. It lists broad categories of recipients rather than named subprocessors: IT, cloud and web-hosting providers, accountants, laboratory providers, suppliers, authorities and courts, the media, the public, and potential acquirers of the business. On the clinical side, the site states that any use of patient material beyond the requested analysis requires appropriate consent, and that reports go to the treating oncologist, who releases copies to the patient.
Reuse rights
Because no terms and conditions are published, the site never says whether a clinician, a hospital or a sponsor may reuse the report or the underlying measurements without asking. What the Privacy Notice does grant, to the extent applicable law provides for it, are the usual data-subject rights: access, rectification, erasure, restriction of processing, objection and portability. Exercising them normally requires proving identity with a copy of an ID document, and Navignostics reserves the statutory limits, such as retention duties, overriding interests or the defense of legal claims. Consent given can be withdrawn at any time with effect for the future by writing to info@navignostics.ch. For patient tissue, any use beyond the requested analysis requires separate consent.
Data retention & training
Hosting summary
Navignostics runs its central laboratory in Switzerland, and its Privacy Notice states that recipients of personal data are generally located there. It also warns that data may go abroad: transfers to countries in the EEA and to the United States are to be expected, because some of the service providers used sit there, Microsoft being the only one named. Where a recipient is in a country without adequate statutory protection, Navignostics contractually obliges it to comply, using the European Commission's revised Standard Contractual Clauses (Decision 2021/914), with the usual derogations for foreign proceedings, overriding public interest, contract performance and explicit consent. Google Analytics runs on the website after consent, with IP addresses shortened by Google in Europe before being forwarded to the USA, and the Data Sharing and Signals options switched off. Beyond this, no data center location, hosting provider or named subprocessor list is published. For the record, the website itself resolves to an address hosted in Zurich, Switzerland, which is a network observation rather than a company statement.
Things to keep in mind
Risks and trade-offs to weigh before adopting Navignostics.
- Research Use Only status: a result must not be read as a regulator-validated diagnosis, and the site itself states the findings are not a clinical recommendation on their own
- Automation bias: a dense report produced by automated computational workflows can carry more weight in a consultation than its research status warrants
- Inconclusive results happen, since not every tumor produces a definitive molecular signal, and an uncertain report may still steer a decision
- Health data is among the most sensitive categories, yet the privacy notice anticipates transfers to the EEA and the United States and can be amended at any time without prior notice
- No terms and conditions are published, leaving ownership of the report and of derived data uncontracted, with no data processing agreement offered and no subprocessor named
- Unequal access: availability depends on a relationship with a partner institution, and the cost is not covered by health insurance
- Patients may over-read a research-context report, which is why the site insists that all treatment decisions remain with the treating oncologist
Setup & Integrations
Technical difficulty
There is nothing technical to set up. No software is installed, no account is created and no integration is required: the clinician sends one FFPE tissue section on a standard pathology slide by regular mail courier, and a PDF report comes back. The site states that no additional clinical procedures are necessary. The real barrier is organizational rather than technical, since access runs through a research program with a partner institution, and the pathology team must first confirm that enough tumor material is available.
Behind Navignostics
Fundraising
Social
Resources
All the official URLs gathered for verification and reference.
Frequently asked questions
What exactly does Navignostics analyze?
What do I receive at the end?
Is a new biopsy needed?
Is this an approved diagnostic test?
Can a patient request the analysis directly?
How much does it cost?
Where is the data processed and stored?
Does Navignostics decide on the treatment?
Is there an API, an app or software to install?
Should you pick Navignostics?
Navignostics occupies a precise niche: it adds a protein and spatial layer on top of conventional pathology and genomic testing, from a single tumor section that would otherwise support only a handful of immunohistochemistry markers. The scientific foundation is unusually solid for a company founded in 2022, a University of Zurich spin-off whose staff co-authored the Nature, Cell, Nature Methods and Cancer Cell papers the site cites, with more than a decade of translational work behind the method and an ISO 13485 certified quality system.
What tempers this is maturity, not credibility. The analysis is Research Use Only, not an approved clinical test, and the company declines to forecast when that will change. Access runs through research programs at partner institutions in Switzerland and Europe rather than a normal ordering channel, so two oncologists facing the same case may not have the same options. Nothing about the commercial terms is public: no price, no plan, no turnaround time, and no terms and conditions at all, only a privacy notice and an imprint. For a service handling health data, the absence of a published data processing agreement, of a named subprocessor list and of an Article 27 EU representative is worth raising before any engagement.
It is also worth being clear about what this is. Navignostics is a laboratory service, not a piece of software: nothing is installed, no API is exposed, and the artificial intelligence claim appears in a funding announcement rather than on the product pages, which speak of advanced data analytics and automated computational workflows. For an oncologist or a trial sponsor with access to a partner program, the offer is substantive and unusually well documented. For anyone expecting a purchasable product, it is not that yet.
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