Abacus Diagnostica Gets CE Mark for Its GenomEra COVID-19 Test

Abacus Diagnostica, part of the Finnish company Uniogen, has received a CE mark for its second-generation COVID-19 test, the GenomEra SARS-CoV-2 2.0 assay kit.

The polymerase chain-reaction (PCR) test, which has 98.3 percent sensitivity and 99.8 percent specificity, is intended for use by healthcare professionals and can detect the SARS-CoV-2 virus in respiratory samples in 50 minutes.

The test’s performance is not affected by the emergence of new COVID-19 variants as it simultaneously detects two different targets in the SARS-CoV-2 virus genome, the company said.