Expanded pharmacogenomic panel enhances safety for patients receiving 5-FU and capecitabine

MASON, Ohio, Jan. 5, 2026 /PRNewswire/ -- Mira Precision Health today announced the official U.S. launch of ToxNav® Advantage™, a clinically validated pharmacogenomic assay designed to identify cancer patients at increased risk of severe or potentially life-threatening toxicities from fluoropyrimidine-based chemotherapies, including 5-fluorouracil (5-FU) and capecitabine (XELODA®).

This launch comes amid heightened concern regarding fluoropyrimidine safety in certain patient populations. The U.S. Food and Drug Administration recently updated the XELODA® (capecitabine) prescribing information to include a Black Box Warning highlighting the risk of severe, life-threatening, and potentially fatal toxicities in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. This warning underscores the urgent need for proactive identification of genetically at-risk patients prior to initiating treatment with fluoropyrimidines.

Key features of ToxNav® Advantage™ include:

• Comprehensive analysis of 23 DPYD gene variants
• Inclusion of DGLUCY and ENOSF1/TYMS variants predictive of fluoropyrimidine-associated cardiotoxicity (CTRCD) and Hand-Foot Syndrome (HFS)
• Rapid 48-hour turnaround time for clinically actionable results
• Clear, clinician-friendly reports that support dose optimization, reduced hospitalizations, and lower treatment-related mortality

The launch will be highlighted by a Mira-sponsored Industry Expert Theater (IET) session at the 2026 ASCO® Gastrointestinal Cancers Symposium in San Francisco, CA.

The 45-minute session, titled "From Oxford to the U.S.: The Clinical Utility Evolution of ToxNav® Advantage™ in Preventing 5-FU/Capecitabine Toxicities," will be presented by Abdul Rahman Jazieh, MD, MPH, Chief Medical Officer of Mira Precision Health. Dr. Jazieh will discuss a real-world case study of fluoropyrimidine-induced cardiovascular toxicity demonstrating the clinical value of variant testing in identifying at-risk patients and informing care decisions.

Professor David Kerr, CBE, MA, MSc, MD, PhD, DSc, FRCP, founder of the original ToxNav® program, internationally recognized oncology researcher, and Chair of Mira Precision Health's Scientific Advisory Board, will also be onsite throughout ASCO-GI. As the architect of ToxNav's scientific foundation and a global leader in fluoropyrimidine toxicity research, Professor Kerr will support the U.S. debut of ToxNav® Advantage™ and be available for expert discussions with clinicians, researchers, and industry stakeholders.

ToxNav® Advantage™ builds on more than a decade of peer-reviewed clinical research and real-world implementation of ToxNav® across U.K. and E.U. healthcare systems. The test analyzes 26 clinically relevant gene variants, including 23 DPYD variants aligned with the Association for Molecular Pathology (AMP) 2025 Tier 1 and Tier 2 classifications, along with additional Oxford-validated markers. ToxNav® Advantage™ uniquely extends fluoropyrimidine toxicity risk assessment beyond DPYD deficiency by incorporating genetic variants associated with cancer therapy–related cardiac dysfunction (CTRCD)—a potentially life-threatening complication—and Hand-Foot Syndrome (HFS), a frequent cause of treatment modification or discontinuation in patients receiving fluoropyrimidines.

"We developed ToxNav® to identify patients with a high likelihood of severe toxicity from 5-FU and capecitabine—two of the most widely prescribed cancer therapies worldwide," said Professor Kerr. "Through our collaboration with Mira Precision Health, ToxNav® has been optimized for the U.S. market, delivering greater clinical utility and rapid turnaround times that can meaningfully improve patient outcomes."

"ToxNav® Advantage™ provides oncologists with fast, actionable insights to help prevent life-threatening toxicities before treatment begins," said Dr. Jazieh. "Our mission is to enable precision-driven care that protects patients across every stage of therapy."

"As a long-time partner of Mira and strong advocate for life science advancement, we're excited to see this partnership with Oxford bring life-changing technology to the U.S.," said Michele Blair, Director of Economic Development for the City of Mason. "We're leaning in to our 'Mason Living Lab' platform, which engages city residents and employees as participants to advance new technology. This program differentiates Mason's position in the Midwestern ecosystem and accelerates science discovery."

About Mira Precision Health

Mira Precision Health is a CLIA-certified, high-complexity clinical laboratory headquartered in Mason, Ohio, specializing in precision medicine diagnostics. Through its advanced pharmacogenomic and oncology testing solutions, Mira empowers clinicians nationwide to deliver safer, more personalized cancer care.

About the City of Mason, Ohio

The City of Mason, Ohio, is an established hub for biohealth and biotech life science companies, with focus areas in cardiology, mental health and precision medicine. Mason was one of the first cities in Ohio designated a Premier Life Science Ready Community in 2025 by the Ohio Life Sciences Association for its infrastructure readiness, dedicated support systems, accessible real estate and high-quality resources that make it attractive to life science development. For more information about the City of Mason, visit www.whymason.com or www.imaginemason.org.

For media inquiries, please contact:
Lori Borchers
Vice President, Sales and Marketing
Mira Precision Health
Email: lborchers@miraprecision.com
Website: https://www.miraprecision.com/toxnav/

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SOURCE City of Mason