Molecular test for Covid-19 granted emergency use authorisation in Finland
Diagnostics player Mobidiag has received emergency use authorisation in Finland for its Amplidiag Covid-19 molecular diagnostic test for the rapid detection of the virus.
The company's Amplidiag Covid-19, which is now available for use in Finland, will be run for routine test use at the country's main clinical laboratories. Mobidiag hopes its test will help double Finnish testing capacity and enable coverage for most of the country. The company is also in the process of obtaining emergency use authorisation for the test in Sweden, the UK and France, and aims to have the test available in Europe in the coming weeks.
Amplidiag Coivd-19 works by taking nasopharyngeal samples from a patient, which are then run via a high-throughput Polymerase chain reaction (PCR) system which can process 48 samples in less than three hours - determining whether a person has Covid-19.
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. Mobidiag states the 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.”