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 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).
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.
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 cancer diagnostics, today announced that four abstracts based on studies using the blood test DiviTum®TKa have been accepted as posters at the world’s largest breast cancer symposium, SABCS, in early December.
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.
Clinical validation completed, work with the FDA submission in the final phase
Biovica carries out a directed share issue of Class B shares and raises proceeds of approximately SEK 148 million
Biovica International AB (“Biovica” or the “Company”) has successfully completed a directed share issue of 4,700,000 Class B shares corresponding to approximately SEK 148 million (the “Directed Issue”). The subscription price in the Directed Issue has been determined to SEK 31.5 per share through an accelerated book building procedure performed by Pareto Securities AB (“Pareto Securities”). Due to significant demand, the gross proceeds in the Directed Issue was increased from the SEK 110 million indicated in the Company’s press release earlier today. A number of Swedish and international institutional investors participated, including Andra AP-fonden, Coeli Asset Management and Lancelot Asset Management.