Abacus Diagnostica will launch a new Covid-19 test in Europe

The Finnish company Abacus Diagnostica is preparing to launch the GenomEra SARS-CoV-2 2.0 test kit, its second generation Covid-19 test, in the European market.

The test recently received CE marking for in vitro diagnostic (IVD) medical devices.

The RT-qPCR multiplex test is designed for the detection of the SARS-CoV-2 virus from respiratory specimens.

With a sensitivity of 98.3% and a specificity of 99.8%, the test provides rapid PCR test results in 50 minutes.

Designed for use by healthcare professionals, the new Covid-19 test includes an integrated sample processing control that targets the mRNA gene.

The GenomEra platform combines the sensitivity of PCR methods and the simplicity of rapid tests in a single system.

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The testing process includes sample collection in an inactivating medium and sample preparation.

GenomEra is fully automated after sample preparation.

Up to four samples can be analyzed simultaneously using one test system. By combining up to eight instruments, the test capacity can be extended to 32 samples.

Abacus Diagnostica CEO Erno Sundberg said: “After further development, we are now proud to be able to offer this second generation Covid-19 test.

“Fast and reliable testing takes usability to a whole new level. Additionally, the test showed exceptional sensitivity and specificity in performance assessments.

The GenomEra SARS-CoV-2 2.0 test can simultaneously identify two different targets, the RdRp and E genes, in the SARS-CoV-2 virus genome. As a result, its performance is not affected by the emergence of different variants of Covid-19.

The company noted that the European Union’s Horizon 2020 research and innovation program funded the GenomEra 2.0 development project.

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Mary I. Bruner