COMPANY:

Biovica

"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"

"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."

"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."

"Biovica...has signed a Master Service Agreement (MSA) for TKa testing with a UK-based pharma biotech company. Under this agreement, Biovica will deliver TKa testing services using its DiviTum® TKa assay and expertise in interpreting TKa measurement dynamics to support drug development and optimize dosing strategies. This collaboration will expand the use of DiviTum TKa in clinical trials investigating next-generation oncology drugs, further increasing the potential for TKa to be established as a biomarker for therapeutic monitoring."

"Biovica...has signed a Master Service Agreement (MSA) with a US-based biotech company...Under the agreement, Biovica will provide TKa testing services utilizing Biovica’s DiviTum® TKa assay and expertise in interpreting TKa measurement dynamics to support drug development and dosage optimization. The agreement will expand DiviTum TKa’s inclusion into a growing list of clinical trials investigating the potential of next generation CDK inhibitor treatment and therefore further increase the likelihood of establishing TKa as a monitoring companion biomarker."

"Biovica...announces that results with DiviTum® TKa from the Spanish GEICAM/2014-12 FLIPPER trial will be presented at the world’s largest cancer conference, the annual ASCO meeting on June 2, 2024 9:00 AM – 12:00 PM CDT. The data supports the use of DiviTum TKa to predict outcome and progression on first line treatment HR+ metastatic breast cancer (MBC) patients providing important clinical information about treatment benefit."

"Biovica...announces that a observational trial with DiviTum TKa has started at Mayo Clinic in Florida. If successful, it will further validate the utility of DiviTum TKa as an effective tool for disease monitoring."