AroCell And Corgenix Establish The Measurement Of Thymidine Kinase 1 Using AroCell TK 210 ELISA In A CLIA-lab In Ihe USA

AroCell AB announce recently, in collaboration with Corgenix (Corgenix Inc., Colorado USA) that the AroCell TK 210 ELISA kit has been validated and approved for Thymidine Kinase 1 (TK1) measurements in human samples for preclinical and clinical use at the Corgenix laboratory facility in Colorado, USA.

This collaboration will make AroCell’s patented biomarker assay available both as a service and as in the already existing AroCell TK 210 ELISA kit for measurements of TK1 protein concentrations in human serum samples. This will provide maximum flexibility for our customers in the USA. It also extends the services that Corgenix offers in their CAP compliant CLIA-lab (Clinical Laboratory Improvement Amendments-lab).

Corgenix has over 25 years of experience in the In Vitro Diagnostic (IVD) industry focused on product development, manufacturing, regulation, distribution and contract services with a CAP/CLIA-lab based in Colorado, USA. A CAP/CLIA-lab is a clinical laboratory for human sample testing that follow CAP standards in USA. The AroCell TK 210 ELISA assay validation has been successfully completed and added to Corgenix laboratory test menu.

“The Corgenix Clinical Laboratory offers clients a regulated environment to understand unique biomarkers in their sample sets” says Kelly R Pitts, Ph.D., General Manager and Chief Scientific Officer at Corgenix. “Adding the AroCell TK1 assay to our menu further expands our ability to serve clients that are extending the boundaries of therapeutic approaches in oncology and beyond.”

“We are excited about this opportunity to collaborate with Corgenix by providing the service of measuring TK1 protein using AroCell´s TK 210 ELISA in their laboratory. This will strengthen our position in the U.S. and is in line with AroCell´s commercialization strategy to make AroCell TK 210 ELISA widely available. It will facilitate the use of TK1 measurements in clinical research as well as for drug development within the pharmaceutical industry” says Michael Brobjer, CEO of AroCell. “The successful validation of our kit into Corgenix facility also proves the robustness and easy handling of the kit.”

Thymidine Kinase 1 is a valuable tumor biomarker and the availability of a TK1 protein assays in a CLIA registered laboratory in the USA will make its application easier and more convenient for the pharmaceutical industry and clinical research.

AroCell TK 210 ELISA is the only available test to measure TK1 protein concentrations in serum blood and is CE marked in EU/ESS.