History

1989

Founded

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

1991

Technology Center Bochum

In 1991, the company moved some research areas to the Technology Center Bochum.

1997

Europe-wide approval for the Helicobacter Test INFAI

In 1997 INFAI received Europe-wide approval for the Helicobacter Test INFAI from the European Medicines Agency EMA, London.

1998

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.

2000

Research and Marketing Technology Centre Cologne

The departments for research and marketing moved to the Technology Center Cologne. The production remained in Bochum.

2001

Development of non-invasive breath tests

Since 2001 INFAI has been researching and developing a range of non-invasive breath tests such as Pancreo-Lip, Gastromotal, Metabo test and Lactoin test (not yet approved).

2002

New Helicobacter blood test

In 2002, a new Helicobacter blood test (Heliblue®) was developed and received an EU patent.

2005

New Helicobacter breath test

In 2005 a new Helicobacter breath test for reflux patients was developed and a patent application was filed in the EU and USA.

2006

US patent for Helicobacter blood test (Heliblue®)

In 2006, the new Helicobacter blood test (Heliblue®) was granted a US patent (2007 EU patent).

2007

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.

2008

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.

2009

EU patent obtained for Helicobacter breath test

2009 EU patent obtained for modified Helicobacter breath test

2010

Clinical trial for Gastromotal started

In 2010, an additional clinical trial for Gastromotal was started to meet the EU approval criteria.

2010

Research Grant

In 2010, INFAI together with its cooperation partner Bruker Biospin received a research grant from INFAI for the Urine Based Newborn Screening Project applying High Resolution NMR Spectroscopy.

2011

Started INFAI

  • 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)

2016

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.

2017

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.

2018

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.

2019

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.

2020

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.