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Biovica Partners with Tempus to Expand Access to DiviTum TKa Blood Test for Metastatic Breast Cancer Monitoring

• Biovica has entered a reference lab agreement with AI-driven precision medicine company Tempus to offer its FDA-approved DiviTum TKa blood test for monitoring treatment response in hormone receptor-positive metastatic breast cancer.

• The collaboration leverages Tempus' network of over 6,500 U.S. oncologists, significantly expanding market reach for DiviTum TKa particularly in the community oncologist segment.

• DiviTum TKa measures the TKa biomarker in bloodstream to monitor cell proliferation, providing oncologists with valuable insights on therapy effectiveness for patients with metastatic breast cancer.

Biovica, a leader in blood-based cancer monitoring, has formed a strategic partnership with Tempus, a prominent AI and data-driven precision medicine company, to expand the commercial availability of its DiviTum TKa test. Under the reference lab agreement, Tempus will incorporate Biovica's blood-based treatment monitoring test into its comprehensive portfolio of diagnostic solutions for oncologists.
The FDA-approved DiviTum TKa test is designed to monitor and predict treatment response in patients with hormone receptor-positive metastatic breast cancer by measuring the TKa biomarker in the bloodstream. This biomarker indicates cell proliferation, providing crucial information about cancer progression and therapy effectiveness.

Strategic Market Expansion

This collaboration represents a significant market expansion opportunity for Biovica, as Tempus currently works with more than 6,500 oncologists across the United States. The partnership will leverage Tempus' established sales network to bring DiviTum TKa to a broader patient population, particularly targeting the community oncologist segment of the U.S. market.
"Tempus represents the future of healthcare by enabling data-driven precision medicine using AI. This collaboration significantly enhances our ability to deliver DiviTum TKa to a broader patient population," said Anders Rylander, CEO of Biovica. "We are confident that our work together will significantly accelerate uptake for DiviTum TKa in the important community oncologist segment of the US market."

Advancing Precision Medicine in Breast Cancer

The collaboration comes at a critical time in breast cancer treatment development. Dr. Ezra Cohen, Chief Medical Officer of Oncology at Tempus, highlighted the rapidly evolving treatment landscape for estrogen receptor-positive breast cancer.
"We are excited to work with Biovica to bring DiviTum TKa to breast cancer patients. The treatment landscape in estrogen receptor-positive breast cancer has improved dramatically in the last 5 years with the introduction of HER2-targeted agents, a new generation of endocrine inhibitors, and the expansion of CDK4/6i into the adjuvant setting," said Dr. Cohen.

Clinical Utility of DiviTum TKa

DiviTum TKa has demonstrated its ability to provide insight into therapy effectiveness across several clinical trials. The blood-based assay offers a less invasive alternative to traditional monitoring methods, potentially improving the patient experience while providing oncologists with valuable data to guide treatment decisions.
The test received FDA 510(k) clearance in the United States and is CE-marked in the European Union, validating its clinical utility and regulatory compliance across major healthcare markets.

Implications for Personalized Cancer Care

By integrating DiviTum TKa into Tempus' precision medicine portfolio, the collaboration aims to support physicians in delivering more personalized patient care. Tempus' AI-driven approach to healthcare, combined with Biovica's specialized biomarker technology, represents a step forward in the ongoing effort to improve treatment monitoring and outcomes for patients with metastatic breast cancer.
Biovica's vision of "Improved care for cancer patients" aligns with the growing emphasis on precision medicine in oncology, where treatment decisions are increasingly guided by specific biomarkers and individual patient characteristics rather than one-size-fits-all approaches.

Future Directions

While the initial focus of DiviTum TKa is on monitoring patients with metastatic breast cancer, the technology's ability to measure cell proliferation through TKa biomarker detection suggests potential applications in other cancer types and treatment scenarios.
As the collaboration between Biovica and Tempus develops, healthcare providers and patients may benefit from improved access to advanced monitoring tools that can help optimize treatment strategies and potentially lead to better outcomes in cancer care.
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