What You Should Know:
- Culmination Bio, a data and technology company combining clinical and biospecimen data, announced a partnership with BillionToOne, Inc., a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all.
- Culmination Bio and BillionToOne are working together to leverage their respective strengths in order to facilitate the development and validation of robust and impactful oncology diagnostics.
Advancing Cancer Diagnostics: BillionToOne Collaborates with Culmination Bio for Validation and Research Acceleration
Utilizing Culmination Bio’s Data Lake and patient recruitment capabilities, BillionToOne aims to validate two diagnostic tests: Northstar Select™, an ultra-sensitive, NGS-based liquid biopsy test for stage III/IV cancer patients, and Northstar Response™, a tissue-free, NGS-based treatment monitoring assay assessing >500 genomic loci uniquely methylated in cancer.
These tests precisely quantify changes in methylated ctDNA to inform treatment efficacy in terms of progression, response, or stable disease. BillionToOne seeks to address cancer profiling challenges and monitor treatment response effectively, crucial for treatment effectiveness determination. The validation process involves utilizing Culmination Bio’s patient base to establish the clinical performance by comparing blinded assay results to known outcomes.
“Our partnership with BillionToOne demonstrates our commitment to advancing healthcare in support of innovative diagnostic solutions”, said Mark Oldroyd, Chief Commercial Officer of Culmination Bio. “By providing access to our research-focused, biospecimen-based data, we’re not only accelerating novel scientific development but paving the way for improving diagnostics which promise to transform oncology care”
This collaboration, comprising two projects, accelerates diagnostic development and facilitates future regulatory submissions. The first project, initiated in early fall, has made significant progress, collecting 60 patient samples, including those with rare mutations. This swift data accumulation underscores the partnership’s efficacy in expediting research. This update coincides with Culmination Bio’s $10M investment from Merck Global Health Innovation Fund (Merck GHIF) and Amgen Ventures, alongside a recent announcement of a multi-year R&D partnership with Merck to study autoimmune diseases. Culmination Bio is revolutionizing healthcare by leveraging biological data enriched with clinical, claims, and genomic data to deliver unparalleled value to healthcare organizations.