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Certifications

Our certifications

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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.

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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.

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

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

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.

Certifications

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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