AroCell announces that it has filed for the CE-mark registration of TK 210 ELISA
AroCell has filed TK 210 ELISA for the CE-mark registration at the Swedish Medical Products Agency (Läkemedelsverket). The CE-mark registration is important for the on going clinical development program and an accepted diagnostic product.
”This is a major milestone for AroCell” states Jan Stålemark, AroCell CEO. “As communicated earlier, we will continue the intensive efforts for clinical documentation for the product by supporting clinical studies. This is important in order to achieve full market acceptance”.
“The ongoing process of establishing evidence-based clinical documentation for our product TK 210 ELISA will be key components which support product benefits for the patients and the healthcare providers. This is what will drive value for our products and services long term” summarizes Jan Stålemark.
For additional information please contact:
Jan Stålemark, CEO
AroCell AB (publ)
Tel: +46706-926206
info@arocell.com
www.arocell.com
About AroCell
AroCell AB is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technologies are based on patented methods to measure TK1 protein levels, which provide valuable information about the speed of cell turnover. A tumor has high cell turnover and as a result TK1 can be detected in the blood with a standard laboratory test, called TK 210 ELISA. The test provides valuable clinical information for prognosis and optimization of treatment strategy. The test may also be used for monitoring disease relapse. For more information, please see www.arocell.com. AroCell is listed at AktieTorget and has about 1 650 shareholders.