Biovica’s DiviTum®TKa at ASCO

Biovica, active in cancer diagnostics, today announces that the company's blood test DiviTum®TKa 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.

2022-05-09T13:15:00+02:00May 9th, 2022 13:15|

Biovica completes 510(k) submission for DiviTum®TKa to the FDA

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

2022-04-28T18:00:00+02:00April 28th, 2022 18:00|

Positive DiviTum®TKa results published in npj Breast Cancer

Biovica, active in cancer diagnostics, today 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. The study supports using DiviTum®TKa to monitor efficacy during treatment and for prediction of response to the CDK 4/6 inhibitor palbociclib, a standard therapy for women with metastatic breast cancer.

2022-03-22T09:30:00+01:00March 22nd, 2022 09:30|

Q3 Interim report – Launch in US with own CLIA laboratory

SEK 000sQ321/22Q320/21May-Jan 21/22May-Jan 20/21Full year20/21Net sales3141,3769631,7592,077Operating profit (loss)-14,417-11,062-40,970-28,012-40,181Profit (loss) for the period-14,334-10,909-40,947-27,491-39,482Earnings per share, after dilution-0.50-0.38-1.44-0.97-1.39Significant events during the third quarter Article on the DiviTum®TKa Budget Impact Model published in the Journal of Medical Economics.Three studies with DiviTum®TKa presented at SABCS 2021.Start of TK IMPACT study at Washington University in St. Louis.Significant events after the end [...]

2022-03-15T08:00:00+01:00March 15th, 2022 08:00|

Nomination Committee for Biovica for the 2022 Annual General Meeting

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. The Nomination Committee then appoints a chairman among its members.

2022-02-18T14:20:00+01:00February 18th, 2022 14:20|

DiviTum®TKa results from PYTHIA published in EJC

Biovica, active in cancer diagnostics, today 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 (EJC). The results demonstrate a predictive capacity of the assay after only two weeks of treatment and supports the use of DiviTum®TKa for optimized information and early therapy efficacy evaluation in metastatic breast cancer.

2022-02-14T10:40:00+01:00February 14th, 2022 10:40|

Biovica provides time-plan for FDA submission

Biovica, active in cancer diagnostics, today announces that it has received full feedback from the FDA on its updated 510(k)-application enabling a clear plan for the submission process. Biovica is now aiming for submission in May 2022.

2022-02-07T21:48:00+01:00February 7th, 2022 21:48|

Q2 Interim report – Promising results published at ESMO

SEK 000sQ221/22Q220/21May-Oct 21/22May-Oct 20/21Full year20/21Net sales268446493842,077Operating profit (loss)-14,314-8,285-26,552-16,950-40,181Profit (loss) for the period-14,388-8,208-26,613-16,581-39,482Earnings per share after dilution-0.51-0.29-0.93-0.59-1.39Significant events during the second quarterBiovica has strengthened its management team with the addition of Warren Cresswell, President Americas, with responsibility for the launch of DiviTum®TKa in the USA.Update on delay in the FDA process.Promising DiviTum®TKa results from the Novartis [...]

2021-12-01T07:30:00+01:00December 1st, 2021 07:30|