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 INFAI developed several non-invasive breath tests, such as Pancreo-Lip, Gastromotal, Metabo-Test and Lactoin-Test. Further approvals for Helicobacter Test INFAI made it available in more than 34 countries worldwide.

During 2002 a new Helicobacter blood test (Heliblue®) was developed which received an EU patent.

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.

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.

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

In 2008 INFAI withdrew the application of Gastromotal in order to continue the clinical program, as recommended by EMA.

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

In 2010 INFAI received a research grant from ZIM Berlin for the Urine-Based Newborn Screening Project applying High Resolution NMR-Spectroscopy.

In 2011 INFAI started a study for the Gastromotal-1-¹³C-Caprylic Acid breath test in the diagnosis and evaluation of therapeutic outcome in patients with dyspeptic symptoms and delayed emptying.

In 2011 INFAI and the University of Nottingham started a study for Helicobacter eradiation to prevent ulcer bleeding in aspirin users: a large simple randomised controlled trial (HEAT).

In 2011 INFAI started a study for the Sensitivity and Specificity in Helicobacter Pylori Positive and Negative Patients with Dypepsia Taking Proton Pump Inhibitors.

In 2012 INFAI and Aptalis initiated a study for efficacy and safety of PYLERA.