INFAI was founded in 1989 by Dr Sitke Aygen at the University of Witten-Herdecke.
Technology Center Bochum
In 1991, INFAI moved to the Technology Center Bochum.
Since 1992 INFAI worked on various clinical studies in cooperation with several hospitals and universities in order to meet the criteria for approval of ¹³C urea breath tests.
Further clinical trials
In 1994, INFAI started several clinical trials for Astrazeneca, Solvay Pharmaceuticals and Altana. (more information see part Helicobacter Test INFAI and Gastromotal)
Application for approval at EMA
In 1996, INFAI submitted a marketing authorization application to the EMA for the diagnosis of Helicobacter pylori infection using the ¹³C breath test.
Europe-wide approval for the Helicobacter Test INFAI
In 1997, INFAI received as first company Europe-wide approval for all EU countries for the Helicobacter test INFAI by EMA (European Medicines Agency) in London.
Installation of a new production line
In 1998 INFAI installed a new production line with an annual capacity of 3 million kits in the Bochum Technology Centre.
Moving to Technology Centre in Cologne
The department for research, development and marketing moved to the Technology Centre in Cologne. The production remained in Bochum
Development of new non-invasive breath tests
INFAI developed several breath tests (Pancreo-Lip, Gastromotal, Metabo-Test and Lactoin-Test).
New ¹³C-Urea blood test
In 2002 INFAI developed a new ¹³C-Urea blood test for helicobacter infection.
EU patent for Gastromotal
In 2003 INFAI received the EU patent for Gastromotal (Gastric emptying test).
New modified breath test
In 2005 INFAI started clinical trials for modified Helicobacter breath test for patients taking PPI and applied for an EU and US patent.
US patent for ¹³C-Urea blood test (Heliblue)
In 2006 INFAI received an US patent for Heliblue.
Gastromotal new Application for EU approval
In 2007 INFAI submitted an application for Gastromotal (a breath test to determine gastric emptying rate) by EMA (European
Medicines Agency, London). The approval will be valid in all European countries through a centralized procedure.
Unlimited approval for Helicobacter pylori test
2007 INFAI received unlimited approval for all European countries for Helicobacter Test INFAI by EMA.
In 2007 INFAI started a study for treatment of symptoms suggestive for gastroparesis by using Gastromotal (Sponsor: Movetis).
Withdrawal of the application for Gastromotal
In 2008, INFAI withdrew the application for Gastromotal in order to perform further clinical trials as requested by the EMA.
INFAI received EU patent for modified Helicobacter breath test
In 2009, INFAI received EU patent obtained for modified Helicobacter breath test for patient taking PPI.
Urea cycle disorders study
In 2009, INFAI started a Pilot feasibility study in healthy subjects and healthy asymptomatic subjects genetically disposed to urea cycle disorders to evaluate the use of ¹³C isotope ratio measurement (Sponsor: Cytonet).
New Clinical trial for Gastromotal
In 2010, INFAI started a new clinical trial for Gastromotal to meet the EMA approval criteria.
US patent for Pancreo-Lip
INFAI received the US patent for Pancreo-Lip for the determination of exocrine pancreatic insuffiency.
Research Grant by ZIM
In 2010, INFAI and Bruker Biospin received a research grant by ZIM for the Urine Based Newborn Screening Project by using NMR Spectroscopy.
Started INFAI several new studies
A new study with ¹³C-octanoic acid breath test for the diagnosis and evaluation of therapeutic treatment in patients with delayed gastric emptying as requested by EMA
INFAI started a study with the University of Nottingham including 40, 000 patients on “Helicobacter treatment to prevent gastric bleeding in aspirin users: a large simple randomized controlled trial (The Helicobacter Eradication Aspirin Trial (HEAT))”
Second study requested by EMA on sensitivity and specificity in Helicobacter pylori positive and negative patients with dyspepsia taking proton pump inhibitors (PPI).
In 2013 INFAI received the US patent for Method for isolating urea while removing objectionable CO2.
In 2014 INFAI received the EU patent for Method for isolating urea while removing objectionable CO2.
The move of the production from Bochum to Hagen
In 2016, the production moved from Bochum to Hagen and a new, modern production line was installed.
INFAI launched the second PPI study
In 2017 INFAI started the second PPI 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 efficacy of various apheresis methods
In 2018, INFAI started a clinical study on the efficacy of various apheresis procedures using the Cardio Test INFAI (Sponsor: INFAI).
Production plant with a serialization system
In 2019 INFAI expanded its production plant with a serialization system to meet the EU Directive 2011/62/EU for the prevention of counterfeit medicines.
Move of research and development to the Bio-Medicine Centre Bochum
In 2020 the department for research and development of INFAI was moved from Cologne to the Bio-Medicine Centre in Bochum.