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Abacus Diagnostica COVID-19 PCR Test Receives CE Marking

NEW YORK – Finnish diagnostics company Abacus Diagnostica announced on Thursday that its GenomEra SARS-CoV-2 2.0 Assay Kit has received CE marking and is being launched in countries accepting the designation.

The PCR test is intended for use by healthcare professionals and returns results in 50 minutes, the company said in a statement. It has a sensitivity of 98 percent and a specificity of nearly 100 percent. According to the company, the performance isn't impacted by different SARS-CoV-2 variants because it detects two different targets in the virus genome. Abacus Diagnostica noted that the sample is collected to an inactivating sample collection media, so dedicated PCR facilities and extensive safety measures aren't required.

The assay runs on the firm's GenomEra CDX platform, which can analyze up to four samples simultaneously.

Uniogen subsidiary Abacus Diagonostica received CE marking for its first SARS-CoV-2 test on the GenomEra system in July 2020. Turku, Finland-based Uniogen was formed when diagnostics companies Abacus Diagnostica, Kaivogen, and Labrox combined at the beginning of 2022.