Press Releases

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

Biovica’s DiviTum®TKa included in new UK breast cancer study

DiviTum®TKa has been selected to be included in a new prospective study of women with hormone receptor positive metastatic breast cancer. The aim of including DiviTum®TKa in the study is to investigate if this marker can be used for disease monitoring during treatment with a CDK4/6 inhibitor, which in combination with an aromatase inhibitor is considered standard of care for this subgroup of patients.

November 23, 2020

Multicenter study PYTHIA presents positive DiviTum®TKa results

Biovica, active in cancer diagnostics, today announced that positive DiviTum®TKa results from the European multicenter study PYTHIA will be presented at the world´s leading breast cancer conference, SABCS, in early December.

November 20, 2020

CDK 4/6 dosing study supports DiviTum®TKa as an early and effective tool in treatment monitoring and prediction of response

Biovica, active in cancer diagnostics, today announced that positive DiviTum®TKa results from a clinical study at the University of Nebraska Medical Center and Washington University School of Medicine, US, will be presented at the world´s leading breast cancer conference, SABCS. The study supports using DiviTum®TKa to monitor efficacy during treatment and predict response to the CDK 4/6 inhibitor palbociclib.

November 19, 2020

Biovica announces initial results in clinical genomics study of DiviTum®TKa

November 18, 2020 — Biovica, active in cancer diagnostics, today announced that initial results from the PROMISE study (NCT03281902) will be presented at the San Antonio Breast Cancer Symposium (December 8-11, 2020).

November 18, 2020

DiviTum®TKa Monitoring Capabilities Confirmed in SWOG Study

Biovica, active in cancer diagnostics, today announced that new DiviTum®TKa results from a large SWOG Cancer Research Network study further strengthen DiviTum®TKa’s monitoring capabilities within metastatic breast cancer. The study, known as S0226, showed impressive data on progression free survival and overall survival. Furthermore, results support that DiviTum®TKa can predict benefit from metastatic breast cancer therapy. The new results will be presented at the world’s leading breast cancer conference, the San Antonio Breast Cancer Symposium, in December.

November 17, 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