Biovica completed meeting with the FDA

On the 22nd of July, Biovica had fruitful meeting with the FDA regarding Supplement II that discusses the approach for clinical validation of DiviTum.

Next step is to document the conclusions from the meeting, which the FDA will review and signoff. This process will take a maximum of 45 days.

Thereafter, Supplement II will be completed, and the result can be concluded and communicated.

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About Us

Biovica develops and commercializes blood-based biomarker assays that improve monitoring of modern cancer therapies and predict patient outcome. The company’s DiviTum® assay, a test for accurately measuring cell proliferation, has successfully demonstrated its capabilities to early evaluate therapy effectiveness in several clinical trials. Biovica aims to make best-possible-treatment from day one a reality. Biovica collaborates with world-leading cancer institutes as well as pharmaceutical companies launching next-generation therapies. The company is ISO 13485 certified for Quality Management Systems. DiviTum™ is CE-labeled and MPA-registered.

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