Oxford Cancer Biomarkers Ltd (OCB), a leader in molecular precision cancer diagnostic tests, has announced a strategic partnership with Mira Precision Health Inc to advance its proprietary ToxNav® test in the United States market. The collaboration, announced following the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting, focuses on a revolutionary precision oncology test that identifies patients most at risk of severe toxicity from 5FU/capecitabine treatment, which in extreme cases can be fatal.
Clinical Significance and Regulatory Alignment
ToxNav® represents a critical advancement in cancer care safety, addressing toxicity risks associated with 5FU/capecitabine, described by Dr. David Kerr, Founder and Director of the Board of OCB and Professor of Cancer Medicine at Oxford University, as "one of the most widely used cancer drugs in the world." The test has already demonstrated clinical proof that it can identify patients susceptible to extreme toxicity.
The diagnostic tool's clinical importance is underscored by its alignment with recent National Comprehensive Cancer Network (NCCN) Guidelines updates that recommend DPYD testing for colorectal cancer patients receiving fluoropyrimidine-based treatments. Shaun Peterson, VP of Sales and Marketing at Mira Precision Health, noted that "The NCCN revision underscores the timely clinical importance of the Mira Precision ToxNav® Test in the US market."
Partnership Strategy and Market Development
The collaboration between OCB, a University of Oxford spin-out, and Mira Precision Health, headquartered at the Mason 5155 BioHub in Ohio, aims to establish substantial future market and sales presence in the United States. Dr. Sandra Gunselman, Founder and CEO of Mira Precision Health, emphasized that the partnership "marks an exciting inflection point for Mira, allowing us to partner with globally-respected academic medical centers and deliver advanced precision medicine directly into clinical practice."
Technology and Evidence Base
ToxNav® enhances clinical decision-making through comprehensive genetic profiling and is backed by multiple peer-reviewed studies and CE-IVD certification in the UK. According to Peterson, the test "significantly improves patient outcomes, reduces healthcare costs, and advances equitable precision medicine."
The diagnostic approach addresses a critical safety gap in cancer treatment, with Karen Merritt, Co-Founder of Advocates for Universal DPD/DPYD Testing, supporting the partnership as "a critical step toward safer, more comprehensive pretreatment DPYD screening to prevent avoidable toxicity and save lives."
Company Backgrounds and Investment
Oxford Cancer Biomarkers develops and commercializes molecular and AI-enabled diagnostic tools that utilize pharmacogenomic markers and digital pathology to optimize cancer treatment pathways. The company's most recent investment came from Plutus Investments Group LLP, a multi-family office focused on Life Sciences, Biotech, Fintech, and Tech investments.
Mira Precision Health was founded to provide advanced molecular diagnostic testing directly to healthcare providers, focusing on clinical genomics, pharmacogenomics expertise, and data informatics tools to enhance clinical decision support and patient safety.
Economic Impact and Future Outlook
The partnership is supported by the City of Mason BioHub, which has seen $600 million in new investment and more than 1,200 jobs announced in 2024, primarily in the biohealth and biotech sectors. Michele Blair, Director of Economic Development for the City of Mason, noted that "The new Mira Precision ToxNav® Test is an excellent addition to our portfolio of technology."
Dr. Kerr expressed optimism about the collaboration's potential impact, stating, "We look forward to a long and productive relationship with Mira Precision as we advance ToxNav to widen its clinical utility in the USA and save more patient lives."
