CE conformity marking and the development of medical technology products follows a seven-step process, where the first three steps involve identification of requirements specification and development to cover them. The product is then verified against the prescribed requirements and validated by potential end users (steps four and five). The development project is then closed, and design transfer to production is done in step six. In the final and seventh step, the product formally obtains its CE mark approval.
Tests for LDH in adults, which have been diagnosed with Covid-19, will be a part of the assessment of the development of the disease course. Studies indicate that the occurrence of increased levels of LDH in early onset of Covid-19 improves the possibilities of identifying patients at risk, assess severity and start the clinical intervention and monitoring. Doing that the prognosis improves and the possibility of recovery increases for the patients. Thus, LDH is an important biomarker for fast triage of patients with Covid-19.
"It is good to see that the project is moving forward," says Anna Söderlund, CEO of Calmark. "The installation of our BioDot machine was a great stride forward and we can now see that the recipe for our LDH chemistry is working well in a large-scale production environment."
This information is information that Calmark Sweden AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 1 September 2020, 17:05 CEST.
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.