Tethis
Updating the operating model
- Biotechnology
- January 2026
A4BEE prepared this analysis from publicly available sources. It reflects our own reading of Tethis's published strategy and is not endorsed by, or produced in cooperation with, Tethis. Company website
Strategic priorities
Tethis operates across 4 stated priorities, with the most concrete near-term plan anchored on standardized sample preparation.
Delivering reproducible, automated liquid biopsy sample processing through the See.d instrument to eliminate variability across global clinical sites
Developing comprehensive cellular and molecular analyses combining CTC capture with plasma genomics for oncology decision support
Transitioning from laboratory prototyping to high-volume manufacturing of nanocoated SBS slides and See.d instruments
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01
Standardized Sample Preparation
Delivering reproducible, automated liquid biopsy sample processing through the See.d instrument to eliminate variability across global clinical sites
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02
AI-Powered Precision Diagnostics
Developing comprehensive cellular and molecular analyses combining CTC capture with plasma genomics for oncology decision support
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03
Commercial Scale-Up
Transitioning from laboratory prototyping to high-volume manufacturing of nanocoated SBS slides and See.d instruments
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04
IVDR Regulatory Compliance
Preparing diagnostic platform for European market entry by meeting post-market surveillance, data integrity, and validation requirements
Challenges we see
- Operations Manufacturing
Nanomanufacturing Yield Variability
SBS slide production involves depositing nanostructured titanium dioxide onto glass substrates, a process highly sensitive to environmental fluctuations including temperature, humidity, and particulate matter.
Scaling from small R&D batches to commercial volumes introduces yield inconsistency, threatening clinical trial validity and regulatory submissions.
- Digital Integration
See.d Instrument Connectivity Gap
The See.d instrument processes blood samples in hospital pathology labs but hospital IT environments are notoriously restrictive, creating barriers to smooth LIMS integration.
Without standardized IT/OT connectivity, the instrument cannot associate physical samples with digital patient IDs, breaking the diagnostic workflow and limiting adoption.
- Digital Operations
Joining records across systems
Tethis generates three distinct data types: process logs from See.d instruments, high-resolution imaging data from SBS slides, and NGS genomic data from plasma analysis, each residing in separate systems.
Manual correlation of instrument performance with image quality slows AI algorithm training and holds back end-to-end patient analysis.
- Compliance Regulatory
RUO to IVDR Regulatory Transition
The See.d platform and SBS slides are currently Research Use Only but the company targets commercialization under the new EU IVDR, which imposes drastically higher standards for clinical evidence and post-market surveillance.
Without automated compliance infrastructure, the regulatory pathway will consume excessive resources and delay market entry.
- Digital Operations
IP Security for Connected Manufacturing
Tethis holds proprietary nanocoating technologies and microfluidics IP that represent the company's core competitive advantage.
As manufacturing equipment connects to cloud systems for data analysis, the risk of IP theft through cyberattack rises significantly.
Opportunities, by urgency and business impact
Each bubble is one opportunity, numbered to match the list below. Further right means it bites sooner; higher means a bigger effect on the business. A bigger bubble means a bigger implementation effort.
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Manufacturing Process Digitalization
The current R&D-focused manufacturing relies on manual assembly, paper-based batch records, and tribal knowledge, creating quality risks as production scales up.
Implementing IIoT sensor arrays and digital batch records to correlate environmental parameters with slide quality, enabling a "Golden Batch" model for predictive quality control.
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Connected Medical Device Infrastructure
The See.d instrument lacks durable connectivity layers to integrate with hospital LIMS and transmit secure, bidirectional data between OT and IT systems.
Deploying IT/OT convergence solutions with OPC UA and HL7/FHIR protocols to make See.d a plug-and-play device in any hospital environment.
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Unified Data Platform for AI Development
Process data, imaging data, and genomic data reside in disconnected silos, preventing the training of end-to-end AI models and slowing diagnostic development.
Building a centralized Industrial Data Platform that creates a "Digital Patient Twin" for each sample, enabling comprehensive AI training on unified datasets.
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Automated IVDR Compliance System
IVDR requires manufacturers to proactively collect field performance data and maintain ALCOA+ data integrity, overwhelming small teams with documentation burden.
Configuring See.d instruments to automatically report post-market surveillance data and implementing validated electronic batch records to satisfy regulatory requirements with minimal human intervention.
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Cybersecurity for OT Assets
Connecting proprietary manufacturing equipment and the See.d instrument fleet to cloud systems exposes critical IP and patient data to security threats.
Implementing Zero Trust security architecture and closed connectivity solutions to create secure wrappers around OT assets while enabling safe cloud data transmission.
What we'd propose
- Digital CDMO
Smart Factory Implementation for Nanomanufacturing
Deploy IIoT sensor infrastructure and digital twin capabilities on SBS slide production lines to achieve predictive quality control and manufacturing consistency at scale.
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OT/IT convergence
DETAIL
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Batch intelligence
DETAIL
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Production release flow
DETAIL
- Shorter lead time from data capture to decision.
- Records that audit on their own, not on inspection day.
- Scale without adding the same headcount.
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- Digital Lab
Connected Instrument Platform for See.d Fleet
Engineer a secure IT/OT convergence layer enabling the See.d instrument to integrate smooth with hospital IT networks while supporting remote fleet management and predictive maintenance.
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Unified data backbone
DETAIL
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Paperless workflows
DETAIL
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Continuous QC release
DETAIL
- Shorter lead time from data capture to decision.
- Records that audit on their own, not on inspection day.
- Scale without adding the same headcount.
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- Enterprise AI
Unified Data Platform for Multi-Modal Analytics
Design and build an Industrial Data Platform that ingests process, imaging, and genomic data streams into a centralized Data Lake, enabling end-to-end AI model development and regulatory-compliant analytics.
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Ontology layer
DETAIL
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Predictive models
DETAIL
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Decision surfaces
DETAIL
- Shorter lead time from data capture to decision.
- Records that audit on their own, not on inspection day.
- Scale without adding the same headcount.
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- Digital Lab
IVDR Compliance Automation Framework
Implement automated validation workflows, electronic batch records, and post-market surveillance data collection to streamline the regulatory pathway from RUO to full IVDR certification.
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Unified data backbone
DETAIL
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Paperless workflows
DETAIL
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Continuous QC release
DETAIL
- Shorter lead time from data capture to decision.
- Records that audit on their own, not on inspection day.
- Scale without adding the same headcount.
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- Digital CDMO
OT Cybersecurity Architecture
Implement Zero Trust security principles and closed connectivity solutions to protect proprietary nanocoating IP and patient data while enabling secure cloud integration for advanced analytics.
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OT/IT convergence
DETAIL
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Batch intelligence
DETAIL
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Production release flow
DETAIL
- Shorter lead time from data capture to decision.
- Records that audit on their own, not on inspection day.
- Scale without adding the same headcount.
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Digital maturity: today and target
Scored out of 100 across six dimensions. The target is what Tethis's own published ambition implies — not a perfect score.
- Manufacturing Digitalization 30 → 75
- Paper-based batch records and manual assembly; needs IIoT sensors, digital twins, and electronic documentation for scale-up
- Data Integration 25 → 80
- Three separate data silos (process/imaging/genomic); requires unified data platform with ontology-based harmonization
- Instrument Connectivity 35 → 85
- See.d lacks standardized hospital IT integration; needs IT/OT convergence layer with OPC UA/HL7 protocols
- Regulatory Compliance Infrastructure 40 → 90
- Moving from RUO to IVDR requires automated PMS, CSV, and ALCOA+ systems beyond current manual processes
- AI/ML Operations 20 → 70
- Reliance on external partners for AI; needs internal MLOps infrastructure for SaMD-compliant model lifecycle
- Cybersecurity Posture 35 → 80
- IP at risk as systems connect to cloud; requires Zero Trust architecture and secure OT connectivity wrappers
Check this yourself
Our Service Portal has free self-assessments and market comparisons. These are the ones that line up with what we've read above — no sales call required.
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Self-assessment
Electronic Batch Record (eBR) Readiness
Check how far your batch records are from paperless, and what the next step is.
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Self-assessment
Find Your LIMS
Answer a few questions about your lab and get a shortlist of LIMS that fit it.
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Market comparison
European CDMOs Compared
The 2026 landscape: who does what, at what scale.
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Market comparison
Digital Lab: Equipment & Integration Map
Which lab instruments connect to which systems, and where the gaps usually are.
Think we've read this right?
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OPC UA protocol support in embedded systems
OPC Unified Architecture (OPC UA) is a modern standard for data exchange, increasingly used in industrial environments.
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Zero Trust Security Principles
The drive to find new resources for innovation and process improvement in life science companies is becoming more based on technologies.
This is an independent analysis prepared by A4BEE from publicly available information as of January 2026. It reflects A4BEE's own interpretation and opinion, is not affiliated with, endorsed by, or verified with Tethis, and may be incomplete or inaccurate. All company names and trademarks are the property of their respective owners. To request a correction or removal, contact [email protected].