Regulatory

FDA resumes review of DiviTum®TKa submission

Biovica, active in cancer diagnostics, today announced that the results from the breast cancer study PROMIX at Karolinska University Hospital is published in the scientific journal ESMO Open. The study showed that testing for TKa levels during early treatment is prognostic for the long-term outcome of preoperative chemotherapy.

The Nomination Committee prior to the 2021 Annual General Meeting will consist of three members, who shall represent the two shareholders with the most number of shares who accept the assignment to be part of the Nomination Committee as of December 31, 2020, and the Chairman of the Board. The Nomination Committee then appoints a chairman among its members.

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has resumed its review of Biovica’s 510(k)-submission for DiviTum®TKa.

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last another 90 days, approximately, during which time the FDA will not be able to continue reviewing Biovica’s submission.

Convincing study results and application submitted to the FDA – commercialization just around the corner

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.

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that it is reallocating resources to COVID-19 impacting the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last approximately 90 days during which time the FDA will not be able to continue reviewing Biovica’s submission.

Biovica, active in blood-based cancer diagnostics, today announced that the company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA).

The following resolutions were passed at the annual general meeting of Biovica AB (publ) on 27 August 2020 in Uppsala.