INFAI was founded in 1989 by Dr Sitke Aygen at the University of Witten-Herdecke.
Technology Center Bochum
In 1991, the company moved some research areas to the Technology Center Bochum.
Europe-wide approval for the Helicobacter Test INFAI
Installation of a production line
The installation of a production line with an annual capacity of three million kits in the Bochum Technology Center completed.
Research and Marketing Technology Centre Cologne
Development of non-invasive breath tests
New Helicobacter blood test
In 2002, a new Helicobacter blood test (Heliblue®) was developed and received an EU patent.
New Helicobacter breath test
US patent for Helicobacter blood test (Heliblue®)
In 2006, the new Helicobacter blood test (Heliblue®) was granted a US patent (2007 EU patent).
Gastric emptying test Application for approval
In 2007 INFAI applied for approval for the gastric emptying test Gastromotal at the EMA, London. Also in 2007 INFAI received the unlimited approval for the Helicobacter Test INFAI from the EMA in all EU countries.
Withdrawal of the application for Gastromotal
In 2008, INFAI withdrew the application for Gastromotal in order to conduct further clinical trials as requested by the EMA.
EU patent obtained for Helicobacter breath test
2009 EU patent obtained for modified Helicobacter breath test
Clinical trial for Gastromotal started
In 2010, an additional clinical trial for Gastromotal was started to meet the EU approval criteria.
- a study of the Gastromotal-1-¹³C-octanoic acid breath test for the diagnosis and evaluation of therapeutic treatment in patients with gastric complaints and delayed emptying.
- with the University of Nottingham a study on Helicobacter treatment to prevent gastric bleeding in aspirin users: a large simple randomised controlled trial (The Helicobacter Eradication Aspirin Trial (HEAT))
- a study on the sensitivity and specificity in Helicobacter pylori positive and negative patients with dyspepsia taking proton pump inhibitors (PPI)
The move of the production from Bochum to Hagen
2016 saw the relocation of production from Bochum to Hagen and the installation of a new modern production facility.
INFAI launched the second REFEX study
In 2017 INFAI started the second REFEX study. This study will investigate the sensitivity and specificity in Helicobacter pylori positive and negative patients with dyspepsia and GERD taking proton pump inhibitors.
Clinical study on the effectiveness of various apheresis
In 2018, a clinical study on the effectiveness of various apheresis procedures was conducted using the Cardio Test INFAI.
Production plant with a serialization system
2019 for the prevention of counterfeit medicines INFAI has expanded its production plant with a serialization system to meet the EU Directive 2011/62/EU.
Relocation of research and development to the Bio-Medicine Centre Bochum
The department for research and development was moved to the Bio-Medical Centre in Bochum.