AroCell AB (publ.) announces today that they expand the CE-mark for AroCell TK 210 ELISA with clinical use in cancer treatment.
The AroCell TK 210 ELISA kit is to be used in clinical and hospital laboratories to aid oncologists in the early detection of treatment response when treating cancer patients; for example, breast cancer patients treated with chemotherapy.
The CE-mark is a certification mark that indicates conformity standard for a product in Europe’s internal market ( (EU/EES). This is a major step in increasing the market potential and sales of the AroCell TK 210 ELISA kit for clinical use in Europe.
“This extension of the CE-mark is in line with our regulatory strategy for Europe. We have now gathered enough clinical data to expand the intended use in the CE-mark. This is an important step for us, that gives us access to the clinical market in Europe.” says Michael Brobjer AroCell CEO.