GFE received CE-IVD certification for new HBV PCR kit.

Frankfurt am Main, 23. November 2020. – GFE today announced the CE-IVD approval of its PoET HBV Kit for use with the new, fully integrated NAT testing solution, the PoET System. With this kit GFE pursues its tradition as a leading supplier of high-quality blood screening solutions.

“GFE is proud to preparing the launch of the successor product line for the autoX-System, which is used for automated testing of millions of blood donations every year.” said Dr. Reiner Babiel, CEO at GFE. “We have upgraded the Hepatitis B assay to a dual-target design, which allows a highly sensitive and reliable detection of the virus. This superior design was introduced successfully in the PCR diagnostics more than 10 years ago and has since been mandated by Paul-Ehrlich-Institute in Germany for HIV screening to further minimize the risk of missing virus variants.”

This is a major milestone in the launch process for the entire PoET product line providing automation and a series of blood screening kits. The market introduction will be jointly with a set of products in early spring 2021.

With HBV being one of the most widespread and chronic infections, particularly in Asia and Africa, GFE has focussed on an exceptional sensitivity and robustness of this assay. This very well goes along with GFE’s preferred strategy of mini pool testing, supporting lower costs per sample and an increased throughput.

GFE is a 100% subsidiary of the three German Red Cross organisations DRK Blutspendedienst West, DRK Blutspendedienst NSTOB, and Bayerisches Rotes Kreuz.