Biovica ISO 13485:2016 certificate renewal

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®. 

2020-04-04T02:29:37+00:00 October 25th, 2019 11:28|News|

Biovica will present at the Biomarkers & Precision Medicine Congress in San Diego

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.

2020-04-04T02:29:37+00:00 October 3rd, 2019 08:45|News|

DiviTum® Included in New U.S. Cancer Study

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.

2020-04-04T02:29:37+00:00 September 18th, 2019 08:00|News|

Biovica invites to telephone conference/audiocast

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.

2020-04-04T02:29:37+00:00 September 18th, 2019 08:00|News|

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.

2020-04-04T02:29:37+00:00 September 17th, 2019 08:00|News|

Plan for 510(k) submission specified – Q1 Interim Report: May-July 2019/2020

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 [...]

2020-04-04T02:29:37+00:00 August 29th, 2019 08:00|Regulatory|

The path to 510(k) submission defined after FDA feedback

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.

2020-04-04T02:29:38+00:00 August 28th, 2019 07:55|Regulatory|

Biovica completed meeting with the FDA

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, [...]

2020-04-04T02:29:38+00:00 July 25th, 2019 12:16|News|

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

2020-04-04T02:29:38+00:00 June 14th, 2019 08:00|Regulatory|

Biovica publishes a summary of study-results in breast cancer with DiviTum®

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.

2020-04-04T02:29:38+00:00 May 22nd, 2019 09:45|News|