Pharmacogenomic Assay ToxNav Advantage Launches in the US to Assess Fluoropyrimidine Toxicity Risk
Key Clinical Takeaways:
- Clinical Context:The US launch of ToxNav® Advantage™ follows a recent US Food and Drug Administration update adding a boxed warning to capecitabine prescribing information, highlighting the risk of severe, life-threatening, and potentially fatal toxicities in patients with dihydropyrimidine dehydrogenase deficiency receiving fluoropyrimidine-based chemotherapy.
- Test Characteristics: ToxNav® Advantage™ analyzes 26 clinically relevant gene variants, including 23 DPYD variants classified as tier 1 or tier 2 by the Association for Molecular Pathology, as well as Oxford-validated markers. The assay also evaluates DGLUCY and ENOSF1/TYMS variants that have been associated with cancer therapy-related cardiac dysfunction and hand-foot syndrome.
- Clinical Application: The assay is intended to support identification of patients who may be at increased risk for fluoropyrimidine-related toxicities, with results reported within 48 hours to inform treatment modification or discontinuation decisions. The test’s clinical background and application will be discussed during a Mira-sponsored Industry Expert Theater session at the 2026 ASCO Gastrointestinal Cancers Symposium.
A new pharmacogenomic assay (ToxNav® AdvantageTM) designed to identify patients receiving fluoropyrimidine-based chemotherapy, including 5-fluorouracil (5-FU) and capecitabine, who may be at increased risk of experiencing severe or potentially life-threatening treatment-related toxicities has launched in the US, according to a release from Mira Precision Health.
This launch follows the recent US Food and Drug Administration (FDA) update to the prescribing information for capecitabine to include a Black Box Warning due to heightened risk of severe, life-threatening, and potentially fatal toxicities among patients with dihydropyrimidine dehydrogenase (DPD) deficiencies.
ToxNav® AdvantageTM was built upon updated peer-reviewed clinical research and the real-world implementation of ToxNav® in UK and European health systems and is powered to analyze 26 clinically relevant gene variants, including 23 DPYD variants recognized by the Association for Molecular Pathology (AMP) as tier 1 and tier 2 classifications and Oxford-validated markers. This assay is additionally powered to identify DGLUCY and ENOSF1/TYMS variants, frequently associated with cancer-therapy related cardiac dysfunction and hand-food syndrome. The test provides physicians with clinically actionable results within 48 hours to optimize time from analysis to treatment discontinuations or modifications.
This launch is accompanied by an Industry Expert Theater (sponsored by Mira Precision Health) that will take place at the 2026 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco, California. During this presentation, Abdul Rahman Jazieh, MD, Chief Medical Officer, Mira Precision Health, Mason, Ohio, will use a real-world case to highlight the clinical value of this test.
Source:
PR Newswire. Accessed January 8, 2026. https://www.prnewswire.com/news-releases/mira-precision-health-based-in-mason-ohio-announces-us-launch-of-toxnav-advantage-at-the-2026-asco-gi-cancers-symposium-302652722.html
