TEST:

DiviTum® TKa test

P=N/A, N=34, Completed, Yale University | Recruiting --> Completed | N=50 --> 34 | Trial completion date: Jan 2028 --> Sep 2025 | Trial primary completion date: Jan 2026 --> Sep 2025

"Biovica...today announces the launch of DiviTum Tka for use in early breast cancer for patients undergoing adjuvant therapy, available as a laboratory developed test (LDT) from its CLIA-certified laboratory in the US. The launch opens a new market indication, representing a potential fivefold expansion of the addressable market for DiviTum TKa."

"Biovica has signed a framework agreement and an initial work order of approximately SEK 0,8 million with an American Tier-1 biopharma company, the fifth in the US. The agreement concerns DiviTum TKa-testing in a Phase I study for next-generation CDK4/6 inhibitors"

P=N/A, N=50, Recruiting, Yale University | Trial completion date: May 2027 --> Jan 2028 | Trial primary completion date: May 2025 --> Jan 2026

"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 cancer meeting, the American Society of Clinical Oncology (ASCO), May 30 - June 3, 2025....The new data further validates DiviTum TKa as a predictive biomarker across three cancer indications: Hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients treated with CDK4/6 inhibitors in the high-profile PEARL study; BRAF V600-mutated metastatic melanoma treated with Immune Checkpoint Inhibitors (ICI); Ovarian cancer treated with platinum-based chemotherapy."

"Biovica...has entered a reference lab agreement with Tempus, a leader in AI and data-driven precision medicine. Tempus will offer Biovica’s blood-based treatment monitoring test, DiviTum TKa, as part of its comprehensive portfolio of diagnostics for oncologists."

"Biovica...today announces that an abstract with DiviTum TKa in a biomarker algorithm will be presented by Karolinska Institutet (KI) at the annual AACR meeting in Chicago on April 25-30, 2025, providing the first evidence that DiviTum TKa in combination with inflammation protein biomarkers significantly improves the ability to stratify patients likely to benefit from immunotherapy."

"Biovica...signed a collaboration agreement with Eurobio Scientific, a leading French group in in vitro specialty medical diagnostics and life sciences, for DiviTum® TKa in Austria, Benelux, France, Germany, Switzerland and the UK. The scope of the agreement covers 60 percent of the total market potential identified as key European markets for Biovica."

P=N/A, N=55, Recruiting, Washington University School of Medicine | Trial completion date: Mar 2027 --> Sep 2029 | Trial primary completion date: Mar 2025 --> Aug 2027

"Biovica...today announces that the company has obtained an out-of-state permit allowing Biovica to offer testing to patients in New York State. Together with previous permits, Biovica is now allowed to offer DiviTum® TKa in all 50 states in the US and Puerto Rico."

"Biovica...that seven abstracts based on studies using the blood test DiviTum TKa will be presented at the world's largest breast cancer meeting, San Antonio Breast Cancer Symposium (SABCS) on December 10-13, 2024. Two of the abstracts validates DiviTum TKa in the adjuvant setting (early breast cancer), which will open a new market opportunity for Biovica."

PFS (p=0.003) and OS (p=0.03) differed significantly by logrank test between the four groups: Low-Low-Low (n=14) median PFS and OS not reached; High-Low-Low (n=26) PFS 23.8m (95%CI can't be calculated) and OS 51.8m (95%CI 15.4 to 88.1); High-Low-High (n=24) PFS 17.5m (95%CI 10.2 to 24.8) and OS 34.3m (95%CI15.1 to 53,7) High-High-High PFS 10.3m (95%CI 1.73 to 18.9) and OS 30.3m (95%CI 15.1 to 45.6) In exploratory analyses no significant differences between median TKa at C1D15 or C2D1, or early TKa dynamic patterns were observed between patients treated with palbociclib (n=48) vs ribociclib (n=29), p=0.33 to 1.0. TKa analysis at later time points is ongoing. TKa is an encouraging biomarker for personalized disease monitoring in MBC.