Press Releases
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.
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.
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.
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.
Q3 Interim report November-January 2020/2021
FDA resumes review of DiviTum®TKa submission
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.
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.
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.
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.
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.