History

INFAI was founded in 1989 by Dr Sitke Aygen at the University Witten-Herdecke.

In 1991 the company transferred from University Witten-Herdecke into the Technology Center, Bochum.

In 1997 INFAI was the first company to receive the European-wide approval of Helicobacter Test INFAI from the European Medicines Authority EMA in London.

In 1998 installation of a production facility with a capacity of 3 million kits per year was finished in the Technology Center Bochum.

In 2000 the Research and Marketing Department was transferred into Technology Center, Cologne. Since then INFAI operates from the facilities in Cologne and Bochum.

Since 2001 the company INFAI is researching and developing a series of non-invasive breath tests such as for example Pancreo-Lip, Gastromotal, Metabo-Test and Lactoin-Test (not yet authorized for marketing).

2002 The marketing authorization of Helicobacter Test INFAI was extended to 30 European countries.

In 2005 a new Helicobacter breath test for patients taking PPIs was developed and filed for EU and US patent. It was granted in 2007.

2006 The US-patent for the new Helicobacter blood test (Heliblue®) received {2007 EU­ patent).

In 2007INFAI 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.

In 2007INFAI received unlimited approval for all European countries for Helicobacter Test INFAI by EMA.

2008INFAI withdrew the application for Gastromotal to perform further clinical trials, as required by the EMA.

2009 The EU patent was received for the new Helicobacter breath test for reflux-patients.

In 2010 an additional clinical trial was started for Gastromotal in order to fulfil the EU registration criteria.

2010 The company INFAI together with their cooperation partner, the company Bruker Biospin received a research grant from ZIM Berlin for the study Urine-Based Newborn Screening Project applying High Resolution NMR-Spectroscopy.

2011 INFAI 

  • starts a study on Gastromotal-1-13C-octanoic acid breath test for the diagnosis and assessment of a therapeutic treatment with patients with gastric complaints and delayed emptying of the stomach.
  • with the University of Nottingham a study on Helicobacter treatment to prevent gastric bleeding with aspirin users: a large single 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 who are taking proton pump inhibitors.

In 2016 the movement of the production from Bochum to Hagen took place as well as the installation of a new state-of-the-art production line.

2017 INFAI has started a new REFEX study. In this study the sensitivity and specificity in Helicobacter pylori positive and negative patients with dyspepsia and GERD, who are taking proton pump inhibitors, is investigated.

2018 for prevention of counterfeit medicines the company INFAI extended their production plant with a serialization system to comply with the EU directives 2011/62/EU.

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