TK IMPACT is an ongoing prospective, single arm trial that assesses the impact of “real-time” DiviTum® TKa test measurements on a physician’s decision about changing usage and/or timing of other routine monitoring tests such as CT scans and other imaging modalities. The study includes patients with advanced HR-positive, HER2-negative metastatic breast cancer receiving endocrine therapy and a CDK4/6 inhibitor.

“This study aims to show the clinical utility of the DiviTum® TKa test in the treatment of metastatic breast cancer. We look forward to helping patients by bringing DiviTum® TKa to market to provide a tool for physicians to better predict treatment efficacy and monitor patients,” said Anders Rylander, CEO of Biovica.

Nusayba A. Bagegni, MD, Oncology Division, Washington University, St Louis, and Principal Investigator, added, “We are in dire need of better biomarkers to help effectively monitor treatment response to endocrine therapy and CDK 4/6 inhibitors in the clinical setting. A number of studies have highlighted the prognostic and predictive nature of serum TK1 activity in this setting. To potentially predict who may do well on therapy and not require such frequent imaging, and others who may benefit from earlier imaging and treatment modification would be the next step in improving cancer care for our patients with HR+, HER2 negative metastatic breast cancer. We are very excited to study the utility of the DiviTum TKa test as a tool to help physician decision-making in the care of patients with metastatic breast cancer in TK IMPACT.”

Poster Presentation Details
The poster (OT3-11-01) will be presented on December 8 at 5:00 PM – 6:15 PM CT at the San Antonio Breast Cancer Symposium, SABCS 2022 (December 6-10). Session Title: Ongoing Clinical Trials: Predictive Biomarkers

TK IMPACT – Treatment Monitoring of Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Metastatic Breast Cancer (MBC) Patients Receiving CDK 4/6 Inhibitors (CDK4/6i) with DiviTum® Serum Thymidine Kinase 1 Activity.