COVID-19 molecular diagnostic test receives Finnish emergency authorisation

Mobidiag has received emergency use authorisation in Finland for its Amplidiag COVID-19 molecular diagnostic test for the rapid detection of the virus.

The Amplidiag COVID-19 test is now available for use in Finland. The test will be run for routine use at the main clinical laboratories in Finland (Helsinki University Hospital (Huslab), SYNLAB and Mehiläinen) doubling Finnish testing capacity and allowing testing coverage for most of the country. The process for obtaining emergency use authorisation is now ongoing in Sweden, UK and France. Mobidiag will register this test for CE-IVD mark and it should be available for widespread use in Europe in the coming weeks.

The Amplidiag COVID-19 assay allows qualitative determination of SARS-CoV-2 (orf1ab and N genes) from nasopharyngeal swabs. Based on high-throughput PCR technology, it can process 48 samples in less than three hours.

Mobidiag is also developing Novodiag COVID-19, a molecular diagnostic test using its Novodiag system for the rapid and on-demand detection of SARS-CoV-2. This test will complement Amplidiag COVID-19 in aiming to allow clinicians to detect COVID-19 infections early, support decisions in managing efficiently epidemiological and infection control measures, isolate patients in a timely manner and improve patient care.

Tuomas Tenkanen, CEO of Mobidiag, said: “At Mobidiag, we recognise that we have a responsibility to support healthcare systems during this extraordinary situation and we are focusing our efforts in this endeavour. There is an urgent and growing need for reliable diagnostic solutions for the early detection of COVID-19, and Mobidiag has been able to leverage its capabilities and existing technologies to develop new diagnostic solutions quickly.  

"We are extremely pleased to bring our first diagnostic solution to the main clinical laboratories in Finland for large volume screening of COVID-19 and look forward to offering tests internationally in due course.” 

Amplidiag COVID-19 is available in Finland as an emergency use test. The tests are only available for healthcare professionals, and not for patients directly.