INFAI has launched a clinical study on cardiovascular disease risk assessment in patients with fatty liver disease in collaboration with Bochum University Hospital (this project is sponsored by the „Zentrales Investitionsprogramm Mittelstand (ZIM)“ in Berlin).

Study Title

Development of an NMR spectroscopy-based screening method for serum lipid profiles and urinary metabolites to assess cardiovascular risk and enable the early detection of type 2 diabetes in patients with MASLD.

The aim of the study is to investigate a non-invasive NMR method for the early assessment of cardiovascular disease risk that goes beyond existing diagnostic procedures.

To this end, a precise, NMR-based diagnostic method will be used for the comprehensive analysis of serum lipid profiles and urinary metabolic markers in MASLD patients. Current methods inadequately capture the complex relationships between metabolic disorders and cardiovascular risks, highlighting an urgent need for more advanced diagnostics. Further development of NMR spectroscopy is intended to enable detailed characterization of lipoprotein subfractions and their particle sizes in serum. The project also aims to standardize sample preparation, automate measurement processes, and establish a comprehensive NMR database to improve application in clinical and research settings. The secondary objective is to investigate the potential for early detection of type 2 diabetes mellitus in patients with fatty liver disease.

Current studies

INFAI is currently conducting the following clinical studies

Study Title: Lipo25UR, Start: 2025
Development of an NMR spectroscopy-based screening method for serum lipid profiles and urinary metabolites to assess cardiovascular risk and enable the early detection of type 2 diabetes in patients with MASLD. Sponsor: INFAI

Study PPI; Eudra CT Number: 2017-001369-25
The Sensitivity and Specificity in Helicobacter Pylori Positive and Negative Patients with Dyspesia Taking Proton Pump Inhibitors. Sponsor: INFAI

Study: Gastromotal; Eudra CT Number: 2011-002782-38
Gastromotal 1-¹³C-Caprylic Acid breath test in the diagnosis and evaluation of therapeutic outcome in patients with dyspeptic symptoms and delayed emptying. Sponsor: INFAI

Study HEAT; Eudra CT Number: 2011-003425-96

Helicobacter eradication to prevent ulcer bleeding in aspirin users: a large simple randomised controlled trial (HEAT). Sponsor: University of Nottingham

Serialization

Implementing the EU’s Falsified Medicines Directive – new line of INFAI packaging

The EU’s Falsified Medicines Directive (2011/62/EU) has been in force since February 9, 2019. The directive is expected to protect the well-being of patients by putting an end to the criminal counterfeiting of medicine.

The Falsified Medicines Directive affects all medicinal products available on prescription.

To implement the directive, the outer packaging of every product shall be furnished with a certificate of authenticity. For the Helicobacter Test INFAI®, this certificate of authenticity is guaranteed by the cellophane wrapping around the single test sampling tubes, and the safety seal on packaging intended for hospital use.

To implement the Falsified Medicines Directive, INFAI has furnished its line of packaging with the latest technology. That way, INFAI can apply all the required safety features, including individual serial numbers, in high quality, and to transmit all the necessary data to the databases of the national verification systems. Thanks to these measures, we can guarantee patients the highest possible level of protection against counterfeits of our products.

Video Link: Falsified medicines