PCR Test for Healthcare Professionals receives CE IVD Approval

A second generation COVID-19 test has been introduced in the European market by Finnish company Abacus Diagnostica part of Uniogen. Its GenomEra® SARS-CoV-2 2.0 Assay Kit which recently received European CE marking for IVD medical devices, is intended for healthcare professionals and can detect the SARS-CoV-2 virus in respiratory samples in 50 minutes.  

The company worked decisively on the development of SARS-CoV-2 diagnostics since the beginning of the COVID-19 outbreak, with its first SARS-CoV-2 assay receiving the CE IVD approval for the European market in July 2020.   

“After further development, we are now proud to be able to offer this second-generation COVID-19 test. The fast and reliable test takes the usability to a whole new level. Additionally, the test has shown outstanding sensitivity and specificity in performance evaluations. The assay kit combines simplicity of use with the superior sensitivity of the PCR method,” said Erno Sundberg, CEO of Abacus Diagnostica.  

The GenomEra® 2.0 development project received funding from the European Union’s Horizon 2020 research and innovation programme.  

“Both the funding and the CE mark prove that our outstanding team has done excellent job in developing the test. Together, we can reach the ambitious goals we have set at Uniogen,” concluded Sundberg.  

More information online