Uppsala, Sweden, October 25, 2019. Biovica, active in cancer diagnostics, announced today that the company has renewed their ISO 13485:2016 certificate for three years following an extensive renewal audit with the company’s accreditation body. The certificate covers the development, manufacturing and sale of DiviTum®.
The 4th Annual Biomarkers & Precision Medicine Congress will be arranged October 8-9 in San Diego, USA. With increased focus on precision medicine follows a need to translate scientific progress into patient benefits through personalized healthcare. The focus of the Biomarker Congress is the discovery and clinical development of biomarkers and Biovica has been invited to present DiviTum®. The congress includes presentations, case studies and panel discussions with participants from global pharmaceutical and biotech companies, as well as academic institutions.
Biovica and the SWOG Cancer Research Network have entered into an agreement to study the clinical benefit of DiviTum® using patient blood samples from SWOG 0226, a clinical trial that showed that women with metastatic hormone receptor-positive breast cancer live longer when they receive a combination of two anti-estrogen drugs.
Uppsala, Sweden, September 18, 2019. Biovica invites investors, analysts and the media to a presentation where Anders Rylander, CEO, and Mattias Bergqvist, Clinical Development Director, comments on today’s announcement. The presentation will be held on 19 September 2019 at 10:00 CET and can be followed via telephone conference or audiocast.
New scientific publication focuses on DiviTum® and highlights the need for biomarkers of CDK4/6 inhibitors
A new publication in the scientific journal Frontiers in Oncology, authored by researchers at the Prato hospital in Italy, emphasize the need to find and utilize biomarkers to identify early treatment resistance and predict the likelihood of successful treatment to a new group of drugs, CDK 4/6 inhibitors. The article focuses on biomarkers and highlights DiviTum® as a technology with great potential, strong rationale and already documented pre-clinical and clinical data to evaluate CDK4/6 inhibitor efficacy.
SEK thousands Q1 19/20 Q1 18/19 May-April 18/19 Net sales 367 914 3,005 Operating profit (loss) -6,097 -3,956 -21,718 Profit (loss) for the period -6,068 -4,028 -21,556 Earnings per share, after dilution -0.33 -0.23 -1.18 Significant events during the first quarter Targeted new share issue for SEK 60 million to European and Swedish institutional investors [...]
Biovica has completed the supplement II process which includes written feedback and physical meetings with the FDA in order to define the process for clinical validation for 510(k) submission for DiviTum®. Biovica also announces that an agreement with a leading oncology group has been signed. The agreement enables Biovica to analyze samples from a large, high impact, clinical trial within metastatic breast cancer. Biovica will use the results in the 510(k) FDA submission and has chosen to extend the time plan in order to include the results as an essential part of the submission.
On the 22nd of July, Biovica had fruitful meeting with the FDA regarding Supplement II that discusses the approach for clinical validation of DiviTum. Next step is to document the conclusions from the meeting, which the FDA will review and signoff. This process will take a maximum of 45 days. Thereafter, Supplement II will be completed, [...]
FDA-process and commercialization on track. New study results confirm the potential. Year-End Report (May-January 2018/2019)
SEK thousands Q4 18/19 Q4 17/18 May-April 18/19 May-April 17/18 Net sales 1,715 1,433 3,005 2,723 Operating profit (loss) -8,569 -4,132 -21,718 -17,956 Loss for the period -8,631 -4,176 -21,556 -18,010 Earnings per share, after dilution -0.47 -0.24 -1.18 -1.01
Biovica has a comprehensive study program with DiviTum® to demonstrate the clinical value for cancer patients. Biovica has published a summary brochure in order to share knowledge about results achieved so far with DiviTum® to researchers, oncologists and other stakeholders. The summary describes all clinical studies presented where DiviTum® is used to evaluate response to breast cancer treatment.