Our certifications


DiviTum® TKa has received a FDA 510(k) clearance in the US

US Food and Drug Administration. July 2022 510(K) Clearances. US FDA website. Published July 29, 2022.


DiviTum® TKa is CE marked according to IVDD and the transitional provisions in Article 110, IVDR 2017/746

Biovica’s development, production, and distribution facility is certified according to ISO 13485:2016.

Medical Device Single Audit Program (MDSAP) U.S. certificate

Biovica's laboratory is CLIA certified

Biovica’s laboratory in San Diego, CA has received CLIA certification on January 13, 2023.


DiviTum® TKa, a product of Biovica, is a blood-based biomarker test that monitors and predicts cancer treatment response.

The DiviTum® TKa test has been demonstrated to be a strong pharmacodynamic tool and early efficacy assay. DiviTum® TKa is FDA 510(k) cleared and CE marked for monitoring postmenopausal women with HR+ metastatic breast cancer, and we are mindful of global registration and assay distribution requirements.

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