Biovica International has announced breakthrough findings for its DiviTum® TKa blood test, revealing its potential to transform immunotherapy treatment decisions when combined with inflammation protein biomarkers. The data, to be presented at the upcoming American Association for Cancer Research (AACR) meeting in Chicago on April 27, 2025, demonstrates the test's ability to identify patients most likely to benefit from immune checkpoint inhibitors (ICIs).
Researchers from Karolinska Institutet and Karolinska University Hospital conducted a translational study in malignant melanoma patients that showed dramatic differences in treatment outcomes based on biomarker profiles. Patients with optimal biomarker profiles achieved a remarkable 83% five-year overall survival rate, compared to just 11% in those with high-risk profiles.
"Our study demonstrates the first evidence that measuring cell proliferation with DiviTum TKa in combination with pro-tumorigenic inflammation markers is of significant value and increases precision to predict treatment efficacy," said Suzanne Egyhazi Brage, Senior Research Specialist at Karolinska Institutet. "We look forward to further studying these biomarkers and their potential to impact long-term outcomes."
Addressing a Critical Unmet Need in Immunotherapy
The findings address a significant challenge in cancer treatment. Immune checkpoint inhibitors have revolutionized therapy for many solid tumors but come with limitations—they can produce severe side effects, and less than half of patients derive meaningful benefit. Better predictive tools could spare non-responders from unnecessary treatment while helping clinicians identify those most likely to respond.
Anders Rylander, CEO of Biovica, highlighted the broader implications: "The results presented at AACR reinforce and broaden DiviTum TKa's utility in oncology. By combining DiviTum TKa with inflammation markers, we have enhanced the ability to identify patients who are more likely to respond to immunotherapy, providing a unique tool for clinicians and pharmaceutical companies developing next-generation immune-based treatments."
The potential market impact is substantial, with more than 150 drug developers currently working on next-generation immune checkpoint inhibitors, according to Global Data. These companies could leverage improved biomarker tools to better identify responder populations, refine clinical trial designs, and demonstrate enhanced efficacy in targeted patient groups.
Expanding Applications Across Multiple Cancer Types
In addition to the AACR presentation, Biovica announced that three abstracts featuring DiviTum® TKa will be presented at the American Society of Clinical Oncology (ASCO) meeting from May 30 to June 3, 2025. These studies further validate the test's utility across three cancer indications:
- Hormone receptor-positive (HR+) metastatic breast cancer patients treated with CDK4/6 inhibitors in the high-profile PEARL study
- BRAF V600-mutated metastatic melanoma treated with immune checkpoint inhibitors
- Ovarian cancer treated with platinum-based chemotherapy
The PEARL study represents a large-scale trial addressing a key clinical decision-making challenge in metastatic breast cancer—whether to select newer versus established treatment combinations. Meanwhile, the studies in melanoma and ovarian cancer explore additional applications for the technology.
"It is exciting that DiviTum TKa will be presented to such a large audience as a predictive biomarker for personalized treatment selection in MBC, malignant melanoma, and ovarian cancer, thereby significantly extending the number of patients who can benefit from DiviTum TKa," Rylander noted.
How DiviTum® TKa Works
The DiviTum® TKa assay measures cell proliferation by detecting thymidine kinase activity (TKa) in the bloodstream, providing a minimally invasive way to monitor cancer progression and treatment response. The test has already received FDA 510(k) clearance in the US and is CE-marked in the EU.
The technology's expanding applications across multiple cancer types and treatment modalities suggest it could become an important tool in the growing field of precision oncology, where treatment decisions are increasingly guided by biomarker data rather than one-size-fits-all approaches.
As immunotherapy continues to evolve with next-generation treatments entering the market, tools that can predict response and monitor treatment efficacy will be crucial for optimizing patient outcomes and healthcare resource utilization. The upcoming presentations at AACR and ASCO will provide the oncology community with important new data on how DiviTum® TKa might help address these challenges.
