Uppsala, Sweden, March 10, 2020. Biovica, active in cancer diagnostics, today announced that the company intends to submit an FDA application for market approval of DiviTum in the third quarter of 2020 and not as previously announced in mid-2020.
“We are pleased with our results in the analytical validation, which is part of our FDA application and so far meet the criteria we have set. However, a component supplier has had delivery delays which means that we now anticipate being able to submit the FDA application a little later than previously expected,” said Anders Rylander, CEO of Biovica.
So far, the results of the analytical validation meet the requirements set by Biovica. Due to delivery delays of a component that is part of DiviTum, production has been delayed. These problems have now been solved but mean that the analytical validation will not be completed until the second quarter.
Biovica's goal is to submit a 510(k) application for market approval to the US Food and Drug Administration, FDA, in the third quarter of 2020.