DiviTum(R) TKa in Three Posters at the World's Largest Breast Cancer Symposium

2023-12-05

临床结果上市批准

UPPSALA, SE / ACCESSWIRE / December 5, 2023 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B) (FRA:9II) Biovica, active in cancer monitoring, today announces that three abstracts based on studies using the blood test DiviTum® TKa will be presented at the world's largest breast cancer symposium, SABCS, in early December. New clinical research for the DiviTum TKa test will be presented at the 2023 San Antonio Breast Cancer Symposium (SABCS) December 5-9, 2023. The three posters reinforce how the DiviTum TKa test has value as a response indicator and predictor for hormone receptor-positive (HR+) patients with metastatic breast cancer (MBC) treated with CDK4/6 inhibitors, the most prescribed drug class for this patient population. "This is the eighth consecutive year that data for our DiviTum TKa test has been accepted by SABCS, the world's largest and most important breast cancer conference. All three abstracts are very interesting but seeing DiviTum TKa performing as well or better than other standard monitoring tools in several patient case studies from the TK IMPACT trial of course makes me extra happy and proud," said Anders Rylander, CEO of Biovica. More about the three abstracts The abstract "Serum thymidine kinase activity as a "real-time" biomarker of tumor response to CDK4/6 inhibition in HR+ metastatic breast cancer HR+ metastatic breast cancer" is based on the ongoing TK IMPACT study at Washington University. A 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 modalities. The abstract highlights several interesting patient case studies from the trial where the DiviTum TKa test demonstrated its capacity to improve monitoring versus other standard monitoring tools. "Genomic and PAM50 correlates of serum thymidine kinase activity (sTKa) in patients (pts) with metastatic breast cancer (MBC) treated with palbociclib (P) and Fulvestrant (F) in the PYTHIA trial" is a sub-analysis from the PYTHIA study for which top-line results have already been presented. The study looked at the correlation between TKa levels, intrinsic breast cancer subtypes, and the presence of the three most common genomic tumor mutations (p53, PIK3CA, and ESR1). The data showed that baseline TKa levels were higher in luminal B and HER2-enriched intrinsic subtypes and that the DiviTum TKa test was more strongly predictive of progression-free survival than the presence of mutations in p53, PIK3CA, or ESR1 genes. "Use of DiviTum-TKa test as a biomarker assay for CDK4/6 inhibitor medication compliance and drug-drug interaction assessment in ER/PR positive metastatic breast cancer" is based on the ongoing prospective clinical trial that was started at Yale in August 2023 to use the DiviTum TKa test to identify suboptimal TKa responses caused by medication compliance or drug-drug interaction issues in patients taking a CDK4/6 inhibitor. Among other things, the trial will assess the correlation between DiviTum TKa test levels and the effects of medication dose reductions in metastatic breast cancer patients. The targeted number of participants is 120 patients, and the study duration is expected to be 12 to 18 months. Contact Anders Rylander, CEO Phone: +46 76 666 16 47 E-mail: anders.rylander@biovica.com Anders Morén, CFO Phone: +46 73 125 92 46 E-mail: anders.moren@biovica.com 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: Attachments DiviTum® TKa in three posters at the world's largest breast cancer symposium SOURCE: Biovica International View source version on accesswire.com: