Biovica files 510(k) submission for breast cancer test

2019 04 15 22 17 2307 Breast Cancer 400

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.

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