- Finnish regulatory authority Fimea has granted special approval for Abacus to supply the GenomEra RUO SARS-CoV-2 test to the Finnish market for diagnostic use
- Tests use the company’s GenomEra technology
- GenomEra uses the so-called PCR technology, which is the most trusted technology for the identification of respiratory infectious diseases
At the end of March Abacus Diagnostica, one of the companies supporting development of the biomarker commercialization tool created by Interreg BIC (Biomarker Commercialization) project, commenced the shipment of GenomEra RUO SARS-CoV-2 test kits to customers in Finland and abroad for research purposes. Now, the Finnish regulatory authority Fimea has granted special approval for Abacus to supply the GenomEra RUO SARS-CoV-2 test to the Finnish market for diagnostic use. FIMEA has concluded that sufficient evidence has been provided for device safety and performance and the clinical need is evident.
GenomEra uses the so-called PCR technology, which is the most trusted technology for the identification of respiratory infectious diseases. The tests are easy to use and rapid: the test results are available about an hour from sample collection. Testing can be performed without specialized knowledge on molecular diagnostics.
“Practically all diagnostics related to Covid-19 are performed on PCR, which is by far the most sensitive method,” explains Erno Sundberg, the CEO of Abacus Diagnostica. “We were able to develop the test within a short time frame, as it is a modified version of our CE IVD approved influenza test. The main difference to our influenza test lies in the gene sequences.”
Abacus Diagnostica, which was established in 2004 by the inventors of the GenomEra® -technology at the Department of Biotechnology at the University of Turku, is a Finnish molecular diagnostics company specialized in rapid molecular testing utilizing the patented GenomEra® -technology. The GenomEra® technology combines a rapid assay principle employing Time Resolved Fluorescence detection with a simple-to-use reagent concept on a low-cost plastic test chip. Using products developed on this technology platform does neither require specific skills in molecular biology nor dedicated laboratory facilities.
For more information visit the Abacus Diagnostica’s webpage
For more information on BIC project visit project’s webpage