Biovica Gets 510(k) Clearance for DiviTumTKa Assay

Uppsala, Sweden-based Biovica has received 510(k) clearance from the FDA for its DiviTumTKa assay for monitoring disease progression in previously hormone receptor-positive, metastatic postmenopausal female breast cancer patients.

The biomarker assay measures the activity of the enzyme thymidine kinase-1 (TK) in blood serum or cell cultures. TK levels are hardly detectable in normal cells, but they can be used as a biomarker to measure the aggressiveness of tumors.

The FDA clearance was supported by study data showing that the assay accurately identified patients in which tumors would not progress within 90 days.