Biovica successfully completes clinical validation for DiviTum® TKa FDA submission
Biovica today announces that the clinical validation of the blood test DiviTum® TKa has been completed, demonstrating the clinical value of the product. The clinical validation is the final part of Biovica’s application for US market approval. Biovica remains on schedule to submit its regulatory filing during September 2020.
“We are very pleased that we have successfully completed the clinical validation in accordance with our timeline. DiviTum® TKa has met its predefined criteria. In the clinical validation, more than 1.700 samples from over 400 patients were analyzed. This is an important step towards finalizing our 510(k) application. This is a major milestone in making the product available for monitoring treatment of metastatic breast cancer and our intention is that DiviTum® TKa should be available to patients in the US early next year," said Anders Rylander, CEO of Biovica.