Biovica completes 510(k) submission for DiviTum®TKa to the FDA
Biovica, active in cancer diagnostics, today announces that the company has submitted its updated 510(k)-application to the U.S. Food and Drug Administration (FDA) to receive marketing authorization for the blood-based biomarker assay DiviTum®TKa.
Biovica’s complete submission addresses the deficiencies identified by the agency on Biovica’s original application, including the feedback received from FDA during the interactive process up until February 2022.
“We are glad to report that our team has worked thoroughly to provide all the remaining information that the FDA asked for. We look forward to making DiviTum®TKa available to breast cancer patients in US through our own CLIA certified lab as a 510(k)-cleared test, which we expect will happen later this year,” said Anders Rylander, CEO of Biovica.
The expected outcome of the submission is either approval (clearance) or a request to submit more information.