Biovica

35 articles with Biovica

• Year-end Report 2021/2022 - Preparations for the Upcoming US Launch

  6/16/2022

  The high point of the quarter was when we submitted our 510(k) application to the US Food and Drug Administration (FDS) for market approval of DiviTum®TKa.

• DiviTum®TKa Predicts Clinical Outcome of Patients in BioItaLEE Study

  6/13/2022

  Biovica announced that the company's blood test DiviTum®TKa was highlighted in an oral presentation on June 6th at the ASCO Annual Meeting from the BioItaLEE trial.

• Biovica's DiviTum(R)TKa at ASCO

  5/9/2022

  Biovica International today announces that the company's blood test DiviTumTKa will be included in one oral presentation and two abstracts/posters, at the world's largest cancer congress, ASCO Annual Meeting, June 3-7, 2022, in Chicago, USA.

• Biovica Capital Markets Day Invitation May 17, 2022

  4/28/2022

  Biovica is approaching market launch of DiviTum®TKa in the US for the monitoring of metastatic breast cancer treatments.

• Biovica Completes 510(k) Submission for DiviTum(R)TKa to the FDA

  4/28/2022

  Biovica, active in cancer diagnostics, announces that the company has submitted its updated 510-application to the U.S. Food and Drug Administration to receive marketing authorization for the blood-based biomarker assay DiviTum®TKa.

• Positive DiviTum(R)TKa Results Published in npj Breast Cancer

  3/22/2022

  Biovica, active in cancer diagnostics, announced that positive results on CDK 4/6 standard therapy from a clinical study at the University of Nebraska Medical Center and Washington University School of Medicine, US, is published in npj Breast Cancer, a Nature open access journal dedicated to publishing the finest research on breast cancer research and treatment.

• Q3 Interim Report - Launch in US with own CLIA Laboratory

  3/15/2022

  In February, just after the end of the quarter, we received feedback from the FDA, which means that we have a plan for our continued application process.

• Biovica Establishes US CLIA Lab to Further Strengthen DiviTum(R)TKa Launch

  3/14/2022

  Biovica, active in cancer diagnostics, announces that the company will establish its own US CLIA lab for the launch of DiviTum®TKa on the US market.

• Nomination Committee for Biovica for the 2022 Annual General Meeting

  2/18/2022

  The Nomination Committee prior to the 2022 Annual General Meeting will consist of three members, who shall represent the two shareholders with the highest number of shares who accept the assignment to be part of the Nomination Committee as of December 31, 2021, and the Chairman of the Board.

• DiviTum(R)TKa Results from PYTHIA Published in EJC

  2/14/2022

  Biovica, active in cancer diagnostics, announces that the positive DiviTum®TKa results from the European multicenter study PYTHIA have been published in the highly ranked peer-reviewed scientific journal European Journal of Cancer.

• Biovica Provides Time-Plan for FDA Submission

  2/7/2022

  Biovica, active in cancer diagnostics, announces that it has received full feedback from the FDA on its updated 510-application enabling a clear plan for the submission process.

• Q2 Interim Report - Promising Results Published at ESMO

  12/1/2021

  Biovica has strengthened its management team with the addition of Warren Cresswell, President Americas, with responsibility for the launch of DiviTum®TKa in the USA.

• Biovica Announces the Start of the TK IMPACT Trial at Washington University of St Louis

  11/24/2021

  Biovica, active in cancer diagnostics, 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’s DiviTum(R)TKa in Three Studies at SABCS 2021

  11/19/2021

  Biovica, active in cancer diagnostics, 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, in early December.

• Biovica’s DiviTum(R)TKa Results Published in Journal of Medical Economics

  11/16/2021

  Biovica, active in cancer diagnostics, announced that the results of a DiviTum®TKa budget impact model have been published in the Journal of Medical Economics.

• Announcement from Biovica International's Extra General Meeting

  10/12/2021

  Biovica International (STO:BIOVIC-B) (STO:BIOVIC.B) (FRA:9II) The extra general meeting was held today on 12 October 2021 and the following resolutions were passed by the meeting.

• Notice of Extra General Meeting in Biovica International AB

  9/23/2021

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

• DiviTum(R)TKa Results from SWOG Study Published in Clinical Cancer Research

  9/15/2021

  Biovica, active in cancer diagnostics, 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.

• Promising DiviTumTKa Results from BioItaLEE Study Presented at ESMO

  9/14/2021

  Biovica, active in cancer diagnostics, announces that DiviTumTKa results from the large BioItaLEE study will be presented as a poster during the European Society for Medical Oncology meeting 16 to 21 September 2021.

• Biovica Provides Update on FDA Application Process

  9/13/2021

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