The Finnish diagnostics company Abacus Diagnostica, part of Uniogen, is launching its second-generation COVID-19 test, the GenomEra SARS-CoV-2 2.0 Assay Kit in the European market. 

The assay kit has recently received European CE marking for In Vitro Diagnostic (IVD) medical devices.  

It is intended for healthcare professionals, and it detects the SARS-CoV-2 virus in respiratory samples in 50 minutes.  

• The assay kit provides rapid PCR test results with 98.3% sensitivity and 99.8% specificity.  
• The sample is collected to an inactivating sample collection media, which means that neither extensive safety measures nor dedicated PCR facilities are required.  
• After a short and simple sample preparation, the assay process is fully automated. The results are automatically interpreted after 50 minutes. With one GenomEra test system, up to four samples can be analysed at the same time. Capacity can be extended to 32 samples by combining up to eight instruments.
• The test performance is not affected by emergence of different COVID-19 variants, as the test simultaneously detects two different targets in the SARS-CoV-2 virus genome – the RdRp and E genes.

Abacus Diagnostica has worked decisively on the development of SARS-CoV-2 diagnostics since the beginning of the COVID-19 outbreak. The first SARS-CoV-2 assay for the GenomEra CDXTM system received the CE IVD approval for the European market in July 2020.   

Erno Sundberg, CEO of Abacus Diagnostica, said: “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.”

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

Sundberg added: “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.”