AroCell expands CE-mark for the AroCell TK 210 ELISA

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.

Contacts

Michael Brobjer, CEO
Telephone: +46(0)18 50 30 20
E-mail: michael.brobjer@arocell.com

About TK 210 ELISA

AroCell TK 210 ELISA is a quantitative immunoassay kit for the determination of Thymidine Kinase 1 (TK1) in human blood. The ELISA format is simple and robust, requires no special instrumentation to perform and can easily be incorporated into standard laboratory processes. By utilizing monoclonal antibodies specific for the TK1 epitope TK 210, AroCell TK 210 ELISA brings improved sensitivity and specificity to the assay of this key biomarker. AroCell TK 210 ELISA provides new opportunities for studying cellular proliferation, disruption, and monitoring of therapy response and relapse in subjects with haematological and solid tumours.

About AroCell

AroCell AB (publ) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein concentrations in a blood sample. The TK 210 ELISA test provides valuable information mainly about the condition of cancer patients. This may help clinicians to optimize treatment strategies and estimate the risk of recurrence of tumor disease during the monitoring of the disease. AroCell (AROC) is listed at Nasdaq First North Growth Market with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90. For more information; www.arocell.com

This information is information that AroCell is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2020-06-10 16:00 CEST.

Attachments

AroCell expands CE-mark for the AroCell TK 210 ELISA