Biovica has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA) for its DiviTumTKa breast cancer test.
The 510(k) submission follows a successful trial that analyzed data from over 400 U.S. and Canadian patients with advanced breast cancer. The test measures the activity of the enzyme thymidine kinase-1 (TK) in blood serum or cell cultures. All patients had hormone receptor-positive disease.
DiviTumTKa is currently sold as research use only, but Biovica plans to make the test available to breast cancer patients in early 2021, the firm said.