Press Releases

Biovica strengthens the management team

Biovica, active in cancer diagnostics, today announced that the company has strengthened the management team with Helle Fisker as new commercial manager and Joakim Arwidson as new quality and regulatory manager.

April 29, 2021

DiviTum®TKa budget impact model results show potential for savings in cost of care

Biovica, active in cancer diagnostics, today announced that the results from a budget impact model of monitoring with DiviTum®TKa can give savings of up to three times the extra spend relative to current management. The results will be presented at the leading health economics and outcomes research conference, ISPOR 2021 in May.

April 23, 2021

Q3 Interim report November-January 2020/2021

FDA resumes review of DiviTum®TKa submission

March 18, 2021

Biovica’s DiviTumTKa prognostic for long-term outcome

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.

March 11, 2021

Nomination Committee for Biovica for the 2021 Annual General Meeting

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.

February 26, 2021

FDA resumes review of DiviTum®TKa submission

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.

January 29, 2021

Biovica’s DiviTum®TKa in early treatment resistance trial

DiviTum®TKa has been selected to be included in the new prospective clinical study TIRESIAS, with the aim of investigating if DiviTum®TKa can be used to identify early resistance to treatment by a CDK4/6 inhibitor in combination with an aromatase inhibitor in breast cancer patients.

January 18, 2021

FDA resource reallocation continues to impact DiviTum®TKa timeline

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.

January 16, 2021

Biovica’s CEO and main shareholder lends shares for redemption of option program

Biovica’s CEO and main shareholder Anders Rylander has, to facilitate the administration of the company’s warrant program 3, lent 127,000 shares to Pareto Securities AB.

January 12, 2021

Biovica Q2 Interim Report August-October 2020/2021

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

December 3, 2020