Biovica’s DiviTum®TKa included in new UK breast cancer study

DiviTum®TKa has been selected to be included in a new prospective study of women with hormone receptor positive metastatic breast cancer. The aim of including DiviTum®TKa in the study is to investigate if this marker can be used for disease monitoring during treatment with a CDK4/6 inhibitor, which in combination with an aromatase inhibitor is considered standard of care for this subgroup of patients.

2020-11-23T07:00:00+01:00November 23rd, 2020 07:00|

CDK 4/6 dosing study supports DiviTum®TKa as an early and effective tool in treatment monitoring and prediction of response

Biovica, active in cancer diagnostics, today announced that positive DiviTum®TKa results from a clinical study at the University of Nebraska Medical Center and Washington University School of Medicine, US, will be presented at the world´s leading breast cancer conference, SABCS. The study supports using DiviTum®TKa to monitor efficacy during treatment and predict response to the CDK 4/6 inhibitor palbociclib.

2020-11-19T07:00:00+01:00November 19th, 2020 07:00|

DiviTum®TKa Monitoring Capabilities Confirmed in SWOG Study

Biovica, active in cancer diagnostics, today announced that new DiviTum®TKa results from a large SWOG Cancer Research Network study further strengthen DiviTum®TKa’s monitoring capabilities within metastatic breast cancer. The study, known as S0226, showed impressive data on progression free survival and overall survival. Furthermore, results support that DiviTum®TKa can predict benefit from metastatic breast cancer therapy. The new results will be presented at the world’s leading breast cancer conference, the San Antonio Breast Cancer Symposium, in December.

2020-11-17T14:35:00+01:00November 17th, 2020 14:35|

Biovica’s FDA submission will proceed to substantive review

Biovica, active in blood-based cancer diagnostics, today announced that the company’s 510(k) submission to the US Food and Drug Administration (FDA) for the blood test DiviTum®TKa will proceed to substantive review when the COVID-19 related pause ends.

2020-11-13T14:20:00+01:00November 13th, 2020 14:20|

FDA resource reallocation impacts DiviTum®TKa timeline

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that it is reallocating resources to COVID-19 impacting the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last approximately 90 days during which time the FDA will not be able to continue reviewing Biovica’s submission.

2020-10-30T07:30:00+01:00October 30th, 2020 07:30|

Biovica’s DiviTum®TKa in four posters at SABCS

Biovica, active in cancer diagnostics, today announced that four abstracts based on studies using the blood test DiviTum®TKa have been accepted as posters at the world's largest breast cancer symposium, SABCS, in early December.

2020-10-23T06:00:00+02:00October 23rd, 2020 06:00|