Biovica’s DiviTum® TKa featured in TK IMPACT study at SABCS
Biovica, active in cancer monitoring, today announces that the unique study design of the TK IMPACT trial, using the DiviTum® TKa blood test, will be presented as a poster at the world’s largest breast cancer symposium, SABCS, on December 8.
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.
Biovica – Treatment decisions with greater confidence
Biovica develops and commercializes blood-based biomarker assays that help oncologists monitor cancer progression. Biovica’s assay, DiviTum® TKa, measures cell proliferation by detecting the TKa biomarker in the bloodstream. The assay has demonstrated its ability to provide insight to therapy effectiveness in several clinical trials. The first application for the DiviTum® TKa test is treatment monitoring of patients with metastatic breast cancer. Biovica's vision is: “Improved care for cancer patients.” Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum® TKa has received FDA 510(k) clearance in the US and is CE-marked in the EU. Biovica's shares are traded on the Nasdaq First North Premier Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser. For more information, please visit: www.biovica.com
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