FDA Resumes Review of AroCell’s Thymidine Kinase 1 Blood Test

AroCell announced that the FDA has resumed its review of the company’s 510(k) submission for AroCell TK 210 ELISA, a blood test for measuring levels of thymidine kinase 1.

The agency had halted its review of the blood test after experiencing COVID-19-related delays, including a heavy load of Emergency Use Authorization (EUA) requests, AroCell said.

The product is a quantitative immunoassay kit for determining the amount of thymidine kinase 1 (TK 1) in the blood. TK 1, an enzyme, plays a big role in DNA synthesis and cell division. AroCell believes its test can help in the research of cells as well as the monitoring of therapy response and relapse in patients with hematological and solid tumors.