Biovica Announces the Start of the TK IMPACT Trial at Washington University of St Louis
UPPSALA, SWEDEN / ACCESSWIRE / November 24, 2021 / Biovica International (STO:BIOVIC-B) (STO:BIOVIC.B) (FRA:9II)
Biovica, active in cancer diagnostics, today announces initiation of the TK IMPACT study, an investigator initiated prospective clinical trial at Washington University of St Louis to evaluate the clinical utility of Biovica's blood-based biomarker assay DiviTum®TKa on monitoring practices in the care of metastatic breast cancer patients.
The study hypothesis is that incorporation of data from DiviTum®TKa measurements into the treatment monitoring of patients receiving standard first line treatment with CDK 4/6 inhibitors plus endocrine therapies, will be associated with the physicians' decision to change usage and/or timing of other routine monitoring tests such as CT scans and nuclear medicine exams. The study will examine care over time of 55 patients that will be tested regularly with DiviTum®TKa.
"We are proud to support the TK IMPACT study which is a key step forward in the development of DiviTum®TKa as it examines the clinical utility of the test on actual care of metastatic breast cancer patients. Our vision is to change the standard of care in monitoring to easy, fast and safe blood-based TKa testing", said Biovica's CEO Anders Rylander.
"An increasing number of our patients with metastatic breast cancer go for many months, even years, without their disease progressing. Nonetheless, as today's standard practice, we often bring them in for repeat imaging exams every three months. This is a burden on the patients. We believe that a convenient blood-based test will enable us to make changes that improve our patients' lives. We are excited to test our ability to make changes in this study" said Dr Nusayba Bagegni, the principal investigator of the study.
Earlier studies have demonstrated that patients with low TKa levels have extended times to disease progression, which enables the possibility to modify and reduce usage of other monitoring exams such as imaging. These other exams represent a burden both on patients and on healthcare costs.
To provide patients, their families, healthcare professionals, and the public with the information about the clinical trial, the TK IMPACT study is listed on the ClinicalTrials.gov website: ( https://clinicaltrials.gov/ct2/show/NCT04968964?term=Bagegni&draw=2&rank=1 )
Anders Rylander, CEO
Phone: +46-18-444 48 35
Biovica - Treatment decisions with greater confidence
Biovica develops and commercializes blood-based biomarker assays to evaluate efficacy of cancer treatments. Biovica's assay DiviTum® measure cell proliferation by detecting a biomarker in the blood stream. The assay has successfully demonstrated its capabilities to early evaluate therapy effectiveness in several clinical trials. The first application for DiviTum is monitoring of treatment for patients with metastatic breast cancer. Biovica's vision is that all cancer patients will get an optimal treatment from day one. Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum is CE-marked and registered with the Swedish Medical Products Agency. Biovica's shares are traded on the Nasdaq First North Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser, email@example.com , +46 8 528 00 399. For more information please visit: www.biovica.com .
SOURCE: Biovica International
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