Biovica, active in blood-based cancer diagnostics, today announced that the company’s 510(k) submission to the US Food and Drug Administration (FDA) for the blood test DiviTum®TKa will proceed to substantive review when the COVID-19 related pause ends.
The FDA has previously informed Biovica about a reallocation of resources, due to a large volume of COVID-19 tests to be reviewed. Based on FDA’s feedback Biovica expects the FDA to resume normal operations and start the substantive review in Q1 2021.
“The feedback from FDA is an important step in the process to DiviTum®TKa’s 510(k) clearance. As soon as normal activities are resumed, the FDA can begin the review,” said Anders Rylander, CEO of Biovica.