Biovica files 510(k) submission for breast cancer test

By staff writers

September 25, 2020 -- 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.

Biovica applies DiviTum in breast cancer study
Biovica is set to retrospectively apply its DiviTum biomarker test for cell proliferation on blood samples of participants in the SWOG Cancer Research...

Copyright © 2020

Last Updated np 9/29/2020 4:42:00 PM

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