#USA #Mason #Mira Precision Health #ToxNav Advantage #ASCO GI Symposium

Mira Precision Health Unveils ToxNav® Advantage™

Mira Precision Health, located in Mason, Ohio, has made a significant announcement with the launch of ToxNav® Advantage™ during the 2026 ASCO® GI Cancers Symposium. This innovative pharmacogenomic assay is clinically validated and aims to enhance patient safety by identifying those at elevated risk for severe toxicities from fluoropyrimidine-based chemotherapy drugs, particularly 5-fluorouracil (5-FU) and capecitabine (known by its brand name XELODA®).

In light of recent updates from the U.S. Food and Drug Administration (FDA), which include a Black Box Warning about the serious risks associated with capecitabine for patients who have dihydropyrimidine dehydrogenase (DPD) deficiency, the need for proactive identification of genetically vulnerable patients has never been more critical. ToxNav® Advantage™ directly addresses this pressing clinical need.

Key Features of ToxNav® Advantage™

ToxNav® Advantage™ stands out with several notable features:

• - A comprehensive evaluation of 23 gene variants relevant to the DPYD gene.
• - Consideration of DGLUCY and ENOSF1/TYMS variants, which are indicative of potential cardiotoxicity and Hand-Foot Syndrome (HFS)—important concerns for oncologists.
• - A rapid turnaround time of just 48 hours, enabling timely clinical actions.
• - Effortlessly interpretable reports that allow healthcare providers to fine-tune dosages, reduce hospital admissions, and lower the risks of treatment-related mortality.

This upcoming launch will be a highlight at the 2026 ASCO® Gastrointestinal Cancers Symposium in San Francisco, where Mira will host an Industry Expert Theater (IET) session. The session, titled From Oxford to the U.S. The Clinical Utility Evolution of ToxNav® Advantage™ in Preventing 5-FU/Capecitabine Toxicities, will be led by Dr. Abdul Rahman Jazieh, Chief Medical Officer of Mira Precision Health. Dr. Jazieh will present a compelling real-world case study illustrating the need for genetic testing in patients undergoing treatment with fluoropyrimidines.

Expert Insights and Validation

Professor David Kerr, the founder of the original ToxNav® program and a prominent force in oncology research, will also be present during the symposium. With his extensive expertise in fluoropyrimidine toxicity research, Professor Kerr will support the introduction of ToxNav® Advantage™ in the U.S. market and engage in discussions with other healthcare professionals and industry stakeholders.

ToxNav® Advantage™ builds upon over ten years of peer-reviewed clinical research, having been successfully implemented within healthcare systems across the U.K. and the EU. This test assesses 26 gene variants that are clinically significant, including 23 associated with DPD deficiency guidelines aligned with the Association for Molecular Pathology (AMP) Tier 1 and Tier 2 classifications, along with additional markers verified in Oxford.

A Mission to Revolutionize Cancer Care

The key objective of ToxNav® is to identify patients who are likely to experience severe toxic effects from 5-FU and capecitabine, two of the most commonly prescribed chemotherapy regimens worldwide. Professor Kerr expressed, “Through our collaboration with Mira Precision Health, we have adapted ToxNav® for the U.S. market, thereby enhancing its clinical utility and decreasing turnaround times—both of which can significantly bolster patient care outcomes.”

Dr. Jazieh echoed this sentiment, stating, “ToxNav® Advantage™ equips oncologists with swift, actionable insights that can help avert life-threatening toxicities before therapy initiates. Our drive is to enable precision-based care that ensures patient safety throughout their treatment journey.”

Innovation Driving Community Growth

Michele Blair, Director of Economic Development for the City of Mason, expressed excitement over the U.S. debut of this groundbreaking technology. “As a long-time partner of Mira and a staunch supporter of life science advancement, we are thrilled about this collaboration and the transformative impact it can have on patient care,” she said. Mason aims to leverage its 'Mason Living Lab' initiative, fostering community engagement in advancing new technologies to position itself favorably in the Midwest's life sciences landscape.

About Mira Precision Health

Mira Precision Health is a high-complexity clinical laboratory certified under CLIA, and it specializes in diagnostics related to precision medicine. Their advanced pharmacogenomic and oncology testing solutions empower medical professionals nationwide to provide safer and more personalized cancer care.

For more information about ToxNav® Advantage™, and how it can enhance cancer treatment safety and outcomes, visit the official Mira Precision Health website.