Development and production of CE-IVD-certified NGS reagent kits, bioinformatics software, and diagnostic protocols for genetic diagnostics.
4bases SA
Manno, Switzerland · Pavia, ItalyNew on Amplifa
About 4bases
4bases is a Swiss company based in Manno (Tessin) with a production site in Pavia (Italy), founded in 2013 to meet growing medical needs in prevention and precision medicine. The company develops and produces clinically validated and CE-IVD-certified genetic diagnostic solutions: reagent kits for platform-independent Next Generation Sequencing (NGS), compatible with Illumina, Thermo Fisher, and Oxford Nanopore, as well as data analysis software and diagnostic protocols. The portfolio comprises two product families: the amplicon-based Panel Family for high-throughput laboratory routine operations and the capture-based Pro Family with optimized coverage uniformity. Applications include oncology, cardiology, hematology, reproductive medicine/IVF, transplantation medicine, and life sciences. 4bases is ISO 13485 certified and operates according to the European In-vitro Diagnostic Directive.
- Site
- CH-6928 Manno
- Processes
- NGS Reagent Kit Production (CE-IVD/RUO, amplicon-based, 'Panel' Family), NGS Reagent Kit Production (capture-based, 'Pro' Family), Data Analysis Software / Bioinformatics (e.g., KaryoSolver™), Lyophilisierung (dry, room-temperature stable NGS workflows, with Meridian Bioscience), NGS Reagent Kits (Amplicon-based Panel Family, Capture-based Pro Family), Data Analysis Software, Diagnostic Protocols, Platform-independent NGS Kits (Illumina, Thermo Fisher, Oxford Nanopore)
- Materials
- Amplicon-based NGS Kits (Panel Family), Capture-based NGS Kits (Pro Family), Room-temperature stable, lyophilized NGS workflows, Data Analysis Software / Bioinformatics
- Certificates
- ISO 13485:2016, ISO 13485
- Founded
- 2013
- Industries
- Molecular Diagnostics / Genetic Diagnostics, Precision Medicine, Oncology, Cardiology, Hematology, Reproductive Medicine/IVF
- 01
Development of NGS reagent kits and panels
- 02
Production (CE-IVD/RUO, amplicon- and capture-based)
- 03
Bioinformatics / Data Analysis Software
- 04
Diagnostic Protocols
- 05
Distribution to laboratories and healthcare professionals
Technologies and Product Families
Amplicon-based NGS Kits (Panel Family)
Simple NGS workflow for high-throughput laboratory routine operations.
Capture-based NGS Kits (Pro Family)
Targeted capture-based sequencing with optimized coverage uniformity per sample.
Room-temperature stable, lyophilized NGS workflows
Dry, stable workflows developed in cooperation with Meridian Bioscience for global availability.
Data Analysis Software / Bioinformatics
Platform for rapid analysis of structural variations (KaryoSolver™).
Sites
Manno
CHSwiss Holding / Headquarters
Pavia
ITSubsidiary / Production Site
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| NGS Reagent Kit Production (CE-IVD/RUO, amplicon-based, 'Panel' Family)Engineering | – | – | – | – | – |
| NGS Reagent Kit Production (capture-based, 'Pro' Family)Engineering | – | – | – | – | – |
| Data Analysis Software / Bioinformatics (e.g., KaryoSolver™)Engineering | – | – | – | – | – |
| Lyophilisierung (dry, room-temperature stable NGS workflows, with Meridian Bioscience)Engineering | – | – | – | – | – |
Additional services
Quality
4bases is ISO 13485 certified; annual audits confirm and renew the certification, which is a prerequisite for the production and distribution of CE-IVD medical devices. Quality assurance continuously works towards compliance with the new EU IVDR requirements.
| Evidence | Manno |
|---|---|
| ISO 13485 |
History
- 2013
Foundations of 4bases to meet growing medical needs in prevention and precision medicine.
- 2020
Confirmation and renewal of ISO 13485 certification (November); Quality assurance working on IVDR compliance (effective from May 2022).
- 2025
Partnership with Platomics for IVDR documentation of laboratory workflows; clinical validation of Oxford Nanopore Long-Read sequencing with 4bases CE-IVD Panels (HEVA pro, CARDIO pro, BRaCA, ClinEX pro).
- 2026
Cooperation agreement with Meridian Bioscience for lyophilized, room-temperature stable NGS workflows and KaryoSolver™.