IVDR-certified: Cystatin C and GCAL® (Plasma and serum calprotectin)
13. Jan 2023 |
4 min read
Committing to the new European Union (EU) quality and safety standards
To ensure continuous compliance for existing and pipeline products, Gentian has since 2017 been preparing for implementation of the European In-Vitro Diagnostic Regulation, EU 2017/746. The Gentian Cystatin C and GCAL® assays are since September 2022 IVDR certified by TüV SÜD. We are now working on the final steps of updating the products' labels and documents. We will inform our customers when this step is finalised.
Since we have a commitment to deliver products of the highest standard and meet our customer needs, we are very pleased to have received this certificate for our first products.
Anne-Mette Akre, VP Quality Assurance and Regulatory Affairs
Our customers and partners have always expected to receive compliant and highest quality products. Addressing the IVDR requirements as early as possible Gentian was able to provide IVDR certified products, ensuring our customers continue to perform testing with highest confidence and efficiency.
Markus Jaquemar, CCO
Although the introduction of IVDR can be seen as a considerable regulatory burden for the industry, it aims to increase the protection of health for patients and users. This new regulation calls for additional performance assessments based on scientific, clinical and analytical data. It also improves traceability in the supply chain and establishes a proactive monitoring system for the early detection of issues in products already in circulation.
Cystatin C and Calprotectin in blood – important biomarkers in the fields of kidney health and inflammation
Gentian Cystatin C Immunoassay - kidney health
Cystatin C is a superior GFR marker for the diagnosis and therapeutic control of renal function1 for patients of all ages. The Gentian Cystatin C Immunoassay (ERM-DA471/IFCC standardised) is an open channel turbidimetric test for quantitative determination of cystatin C in human serum and plasma.
GCAL® - Detection and assessment of inflammation
The Gentian Calprotectin Immunoassay (GCAL®) is the first turbidimetric assay for the quantitative measurement of calprotectin in plasma and serum intended as an aid in the detection and assessment of inflammation. The open channel assay can be applied on a wide range of automated clinical chemistry analysers.
Partnering with Gentian - Business opportunities
Both the Gentian Cystatin C Immunoassay and the Gentian Calprotectin Immunoassay (GCAL®) are particularly suitable as part of an OEM solution for B2B partners to fill identified gaps in their assay portfolios.
These newly IVDR-certified products combined with Gentian’s robust manufacturing capabilities will offer a very attractive solution for Gentian’s B2B partners with excellent and reliable long-term supply security. Formulations or solutions of these products available are:
For more information - get in touch!
Are you interested in adding our assays to your test menu, distributing our products or to discuss OEM opportunities for your company? Partner with us for high quality, security of supply, customisation and expertise.