DiviTum®TKa results from SWOG study published in Clinical Cancer Research
Biovica, active in cancer diagnostics, today announces that DiviTum®TKa results from an analysis of samples from the large SWOG S0226 study have been published in the highly ranked peer-reviewed scientific journal Clinical Cancer Research, published by the American Association for Cancer Research (AACR). The strong results support using DiviTum®TKa as a tool to monitor disease progression with endocrine therapy in women with hormone receptor positive metastatic breast cancer.
“SWOG researchers have demonstrated that a blood serum test can identify which of these patients have slow-growing disease that might be controlled with a simple aromatase inhibitor pill alone,” said co-author of the paper, Dr. Lajos Pusztai, MD, PhD, Yale University Cancer Center. “We are very proud to see the strong DiviTum®TKa results being published in Clinical Cancer Research. This highly reputable scientific journal by AACR focuses on innovative clinical and translational research bridging the laboratory and the clinic. The publication is a great recognition for DiviTumTKa and an important step to establishing the test as a standard tool for monitoring treatment of metastatic breast cancer to the benefit of patients and payers,” said Anders Rylander, CEO of Biovica.
As previously announced, results demonstrate that patients with low TKa levels (using a predefined cut-off) before treatment initiation will do significantly better than patients expressing high levels of TKa. Progression free survival (PFS) was 17.3 vs 11.2 months and overall survival (OS) was 58 vs 30 months, respectively. In addition, similar results were observed during treatment, where patients with low TKa showed significantly longer PFS and OS. Furthermore, results support the potential clinical use of DiviTum®TKa to identify low-TKa patients as best suited for endocrine monotherapy, whereas those with elevated TKa values appear to benefit from combination therapies.
The analysis measured thymidine kinase activity (TKa) levels in 1,726 serum samples from more than 400 patients in SWOG S0226 and is the largest study to evaluate DiviTum®TKa for prognostic and serial monitoring of metastatic breast cancer. The study constitutes the foundation for the clinical validation of DiviTum®TKa in Biovica’s 510(k)-application to the FDA. DiviTum®TKa is 510(k) pending. Not available for sale in the United States.
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.
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