INFAI has launched a new project on cardiovascular disease risk assessment in fatty liver patients (this project is sponsored by Zentales Investitionsprogramm Mittelstand (Central Innovation Programme for small and medium-sized enterprises; ZIM) in Berlin)

Development of an NMR spectroscopy-evaluating screening of lipid profiles in serum and metabolites in urine for the assessment of cardiovascular risk and early detection of type 2 diabetes in MASLD patients.

The planned project aims to develop a highly precise, NMR-based diagnostic method for the comprehensive analysis of lipid profiles and metabolic markers in MAFLD patients. The goal is to provide a non-invasive method for early cardiovascular disease risk assessment that goes beyond existing diagnostic procedures. Current methods inadequately capture the complex relationships between metabolic disorders and cardiovascular risks, thus creating an urgent need for more advanced diagnostics. Further development of NMR spectroscopy will enable detailed detection of major and subclasses of lipoproteins, as well as their particle sizes. 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.

Current studies

INFAI is currently conducting the following clinical studies

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