Regulatory

SEK 000s Q221/22 Q220/21 May-Oct 21/22 May-Oct 20/21 Full year20/21 Net sales 268 44 649 384 2,077 Operating profit (loss) -14,314 -8,285 -26,552 -16,950 -40,181 Profit (loss) for the period -14,388 -8,208 -26,613 -16,581 -39,482 Earnings per share after dilution -0.51 -0.29 -0.93 -0.59 -1.39 Significant events during the second quarter Biovica has strengthened its […]

Biovica, active in cancer diagnostics, today announces initiation of the TK IMPACT study, an investigator initiated prospective clinical trial at Washington University of St Louis to evaluate the clinical utility of Biovica’s blood-based biomarker assay DiviTum®TKa on monitoring practices in the care of metastatic breast cancer patients.

Biovica, active in cancer diagnostics, today announced that results from three different studies using DiviTum®TKa, including a budget impact model, will be presented at the world’s largest breast cancer symposium, San Antonio Breast Cancer Symposium (SABCS), in early December. The studies are of a next generation CDK inhibitor, samuraciclib from Carrick Therapeutics, the biomarker study PROMISE performed at the Mayo Clinic, and the DiviTum®TKa budget impact model. All studies focused on the role of DiviTum®TKa in monitoring treatment in women with metastatic breast cancer.

Biovica, active in cancer diagnostics, today announced that the results of a DiviTum®TKa budget impact model have been published in the Journal of Medical Economics. This publication expands on data presented at the ISPOR 2021 meeting. The model’s results show that monitoring with DiviTum®TKa may achieve savings of up to three times the extra spend relative to current management of metastatic breast cancer patients.

The extra general meeting of Biovica International AB (“Biovica” or the “Company”) was held today on 12 October 2021 and the following resolutions were passed by the meeting.

The shareholders of Biovica International AB, reg. no. 556774-6150, (the “Company”) are hereby invited to the extra general meeting on Tuesday 12 October 2021.

Biovica, active in cancer diagnostics, today announces that DiviTum®TKa results from an analysis of samples from the large SWOG S0226 study have been published in the highly ranked peer-reviewed scientific journal Clinical Cancer Research, published by the American Association for Cancer Research (AACR). The strong results support using DiviTum®TKa as a tool to monitor disease progression with endocrine therapy in women with hormone receptor positive metastatic breast cancer.

Biovica, active in cancer diagnostics, today announces that DiviTumTKa results from the large BioItaLEE study will be presented as a poster during the European Society for Medical Oncology (ESMO) meeting 16 to 21 September 2021. The results strengthen the potential of DiviTum®TKa as a treatment monitoring devise for CDK4/6 inhibitor treatments.

Biovica, active in cancer diagnostics, today announced that the company’s expected timeline for its updated 510(k)-application to the US Food and Drug Administration (FDA) has been prolonged due to delay in response from FDA.

The annual general meeting of Biovica International AB (“Biovica” or the “Company”) was held today on 31 August 2021 and the following resolutions were passed by the meeting.