Develops and produces nanofluidic point-of-care diagnostics for the early detection of sepsis from a single drop of blood.
Abionic SA
Epalinges (CH)New on Amplifa
About Abionic
Abionic SA is a medical technology and diagnostics company founded in 2010 as a spin-off of EPFL, headquartered at the Biopôle in Epalinges near Lausanne. The company develops and manufactures the abioSCOPE® point-of-care diagnostic system as well as the accompanying single-use test capsules (IVD CAPSULE), which deliver laboratory-quality results from a drop of blood within minutes using nanofluidics. The core product is the PSP test (Pancreatic Stone Protein) for the early detection of sepsis in emergency departments and intensive care units; the portfolio also includes ferritin, D-dimer and allergy panel tests. Production takes place on an automated, ISO-certified production line at the company's own plant. Abionic is certified according to ISO 13485, its products carry the CE mark or are certified under the EU IVDR; the PSP test received FDA 510(k) clearance in 2024. In 2023, the company was awarded the Swiss Medtech Award.
- Site
- Epalinges
- Processes
- Near-patient rapid diagnostics (abioSCOPE®), PSP biomarker test for early sepsis detection, Ferritin point-of-care test, D-dimer test, Allergy panels
- Materials
- Nanofluidics, Pancreatic Stone Protein (PSP)
- Certificates
- ISO 13485, CE Mark, EU IVDR, FDA 510(k) Clearance (PSP test), CE marking, FDA 510(k) (PSP test)
- Founded
- 2010
- Industries
- Medical technology/diagnostics, Hospitals (emergency department, intensive care unit, ward), Pediatrics/neonatology, Pediatrics/neonatology
- 01
Research & Development (nanofluidics, biomarkers)
- 02
Automated manufacturing of IVD capsules
- 03
ISO-certified quality control
- 04
Regulatory certification (CE, IVDR, FDA 510(k))
- 05
Sales and clinical use at the point of care
Technology & Processes
Nanofluidics
Core process of the abioSCOPE® platform for rapid analysis of biomarkers from a drop of blood.
Pancreatic Stone Protein (PSP)
Blood biomarker for the early detection of sepsis, measured exclusively on the abioSCOPE®.
Location
Epalinges
CHHeadquarters, manufacturing and R&D (Biopôle, Lausanne)
- Materials
- IVD capsules (PSP, ferritin, D-dimer, allergy)
- Automated ISO-certified production line (2016)
Products & Tests
Inside the production
Industries
2 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Automated production line (IVD diagnostics) | – | 1 | – | 2016 | Biopôle, Lausanne / Epalinges, Switzerland |
| Point-of-care diagnostics platform (abioSCOPE®, nanofluidics, own product, not a manufacturing | Abionic abioSCOPE® | – | – | 2020 | Epalinges, Switzerland |
Additional services
Quality & Certification
Quality assurance follows a certified quality management system according to ISO 13485; products are CE-marked or certified under the EU IVDR, and the PSP test carries FDA 510(k) clearance.
| Evidence | Epalinges |
|---|---|
| ISO 13485 | |
| CE marking | |
| EU IVDR | |
| FDA 510(k) (PSP test) |
History
- 2010
Founded as a spin-off of EPFL
- 2012
First technology demonstration, ISO 13485:2003 certification, Series A financing of 3.5 million CHF, Swiss Excellence Product Award
- 2014
Series B financing of 8.2 million CHF
- 2015
First allergy panel prototype completed
- 2016
New premises at the Biopôle Lausanne, automated ISO-certified production line, Ambassador of Health Valley Switzerland
- 2017
Ferritin PoC test and PSP sepsis test CE-marked, first allergy panel registered with the FDA, Series C financing of 25 million CHF
- 2018
ISO 13485:2016 certification, sepsis impact study in 14 intensive care units in 4 EU countries
- 2019
Sepsis study in the USA, abioSCOPE® CE-marked
- 2020
Start of commercialization of the abioSCOPE®
- 2021
Expansion of the PSP test into key markets
- 2022
IVD CAPSULE PSP IVDR-certified (since July 2022), IVD CAPSULE D-DIMER CE-marked
- 2023
Swiss Medtech Award winner
- 2024
Patrick Pestalozzi becomes new CEO, FDA 510(k) clearance for the PSP test