Biovica, active in cancer diagnostics, today announced that the analytical validation of the blood test DiviTum has been completed. The validation aims to verify technical and precision requirements defined in consultation with the US Food and Drug Administration (FDA). The analytical validation is an important part of the application for US market approval.
“It is with great satisfaction that we have carried out the analytical validation and passed the criteria we set up after discussion with the FDA. It is a big step towards completing our 510(k) application. Now the work on the clinical validation continues and as previously announced, we plan to submit our application in the third quarter of 2020. Our hope is thus that DiviTum will be available to patients in the US early next year," said Anders Rylander, CEO of Biovica.
A total of 15 extensive trials have been carried out to ensure DiviTum®'s performance. The validation has included analytical sensitivity, linearity, precision, stability, interference and usability. The trials have been carried out both at Biovica's laboratory in Sweden and at external laboratories in the US that are approved by the FDA, so-called CLIA laboratories.