Results for Calmark's initial biomarker, bilirubin, are within the expected range - project enters verification and validation phase to obtain CE mark

Results for Calmark's initial biomarker, bilirubin, are within the expected range - project enters verification and validation phase to obtain CE mark

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Calmark Sweden AB (publ) announces today that the development project for the Company's first biomarker, bilirubin, is now progressing to verification and validation. This phase, which is one of the final elements of the process, is estimated to last for approximately eight weeks. When it is completed, regulatory documentation will be compiled in order to achieve the CE Mark approval. This means that bilirubin will obtain its CE mark according to plan.

"Today's decision marks an important milestone for Calmark. We can now ascertain that we can satisfy our technical requirements on measurement accuracy. The results of analysis fall within the expected range when compared to the reference laboratory at Karolinska University Hospital. We are confident to bring the first biomarker, bilirubin, into the final phase of the project," says Anna Söderlund, CEO of Calmark. "Since the reader obtains its CE marking together with each respective biomarker, the initial project is also the most extensive - so I am very happy that we are on our way to achieve this."