Regulatory

Biovica Capital Markets Day invitation June 9

Biovica, active in cancer diagnostics, will host a virtual Capital Markets Day on Wednesday 9 June from 14.00 to 16.30.

May 22, 2021

Biovica’s DiviTumTKa shows strong capabilities in malignant melanoma

May 20, 2021 – Biovica, active in cancer diagnostics, today announces that DiviTumTKa shows prognostic and predictive capabilities in metastatic cutaneous melanoma patients undergoing immunotherapy. These results from a new study at Karolinska University Hospital will be presented at the upcoming ASCO annual meeting, June 4-8, 2021.

May 20, 2021

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

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

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 Q2 Interim Report August-October 2020/2021

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

December 3, 2020

Biovica’s FDA submission will proceed to substantive review

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.

November 13, 2020