Beyond Standard DPYD Testing

Clinically Proven to Protect Patients from
5-FU/Capecitabine (XELODA®) Toxicity

DPYD Deficiency

23 Gene Variants including AMP Tier 1 & Tier 2 plus additional
Oxford-validated variants

Clinical Incidence

  • 2–8% general population

Cancer Therapy-Related Cardiotoxicity

DGLUCY

1 Gene Variant

Clinical Incidence

  • 2–18% general population

Hand-Foot
Syndrome

ENOSF1/TYMS

2 Gene Variants

Clinical Incidence

  • 11–24% general population

Fast turnaround time of 48 hours
Non-invasive, buccal swab sample collection
Easy & actionable clinical report

Unmasking Hidden Risks:

Fluoropyrimidine toxicity remains a serious and preventable clinical risk.

Despite their widespread use, fluoropyrimidine-based chemotherapies can cause severe or fatal toxicities in genetically susceptible patients. Identifying those patients prior to treatment is critical to improving safety, outcomes, and confidence in care decisions.

ToxNav® Advantage™ goes beyond DPYD deficiency.

It assesses additional genetic variants linked to serious fluoropyrimidine-related toxicities, including:
  • Cancer therapy–related cardiac dysfunction (CTRCD), a potentially life-threatening complication
  • Hand-Foot Syndrome (HFS), a common cause of dose reduction or treatment discontinuation
This broader genetic insight helps identify patients who may be at higher risk before treatment begins.

The Current Clinical Challenge

for Physicians Prescribing 5-FU/capecitabine chemotherapy

Standard chemotherapy dosing doesn’t account for genetic differences in drug metabolism. Patients with DPD deficiency are unable to effectively break down 5-FU or capecitabine, leading to drug accumulation and heightened toxicity risks. Without pre-treatment screening, these patients remain unidentified until adverse reactions occur, which can be life-threatening.

Key features of ToxNav® Advantage™ include:

    • Rapid 48-hour turnaround time for clinically actionable results
    • 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)
    • Clear, clinician-friendly reports that support dose optimization, reduced hospitalizations, and lower treatment-related mortality
Clinically validated and economically impactful, ToxNav® Advantage™ identifies patients at significant risk of severe toxicity from 5-FU and capecitabine chemotherapy. Supported by robust peer-reviewed evidence, ToxNav® Advantage™ empowers personalized treatment decisions, reduces healthcare costs, and significantly improves patient outcomes and quality of life.
“We developed our ToxNav test to identify cancer patients that have a high likelihood of undergoing extreme toxicity to 5FU/capecitabine treatment, which is one of the most widely used cancer drugs in the world. We have already clinically proven that ToxNav identifies patients susceptible to extreme toxicity and are excited to have partnered the test with Mira Precision, who have complementary expertise to advance ToxNav in the USA. 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.”

Dr. David Kerr, Founder and Director of the Board of OCB, Professor of Cancer Medicine, Oxford University

Clinical and Economic Impact Backed by Peer-Reviewed Evidence:

  1. Clinical Efficacy Proven: Real-world clinical studies consistently demonstrate ToxNav® Advantage’s ability to accurately identify patients at elevated risk of severe chemotherapy-related toxicity, enabling proactive management and enhanced patient safety (Meulendijks et al., 2015).
  2. Healthcare Cost Reduction: Evidence clearly shows that preemptive genetic testing significantly reduces hospital admissions due to toxicity-related complications, translating into substantial cost savings for healthcare systems (Henricks et al., 2019).
  3. Improved Patient Outcomes: Peer-reviewed research confirms that genetic screening using tools like ToxNav® Advantage™ markedly reduces severe adverse drug reactions, significantly improving patient survival rates and overall treatment experience (Deenen et al., 2016).
  4. Value-Based Care Alignment: Economic analyses highlight how precision oncology tests, such as ToxNav® Advantage™, align seamlessly with value-based healthcare models by reducing unnecessary expenditures and enhancing clinical outcomes (Lunenburg et al., 2020).
  5. Enhanced Treatment Adherence: Studies have validated that identifying at-risk patients upfront increases patient adherence and satisfaction, thereby reducing treatment interruptions and improving overall quality of cancer care (Amstutz et al., 2018).

References

  • Koleva-Kolarova, R., Vellekoop, H., Huygens, S., Versteegh, M., Rutten-van Mölken, M., Szilberhorn, L., … Tsiachristas, A. (2023a). Cost-effectiveness of extended DPYD testing before fluoropyrimidine chemotherapy in metastatic breast cancer in the UK. Personalized Medicine, 20(4), 339–355. https://doi.org/10.2217/pme-2022-0099
  • Koleva-Kolarova, R., Vellekoop, H., Huygens, S., Versteegh, M., Rutten-van Mölken, M., Szilberhorn, L., … Tsiachristas, A. (2023b). Budget impact and transferability of cost-effectiveness of DPYD testing in metastatic breast cancer in three health systems. Personalized Medicine, 20(4), 357–374. https://doi.org/10.2217/pme-2022-0133
  • Le Teuff, G., Cozic, N., Boyer, J.C., Boige, V., Diasio, R.B., Taieb, J., … Etienne-Grimaldi, M.C. (2024). Dihydropyrimidine dehydrogenase gene variants for predicting grade 4-5 fluoropyrimidine-induced toxicity: FUSAFE individual patient data meta-analysis. British Journal of Cancer, 130, 808–818. https://doi.org/10.1038/s41416-023-02517-2
  • Lee, L.Y.W., Starkey, T., Sivakumar, S., Fotheringham, S., Mozolowski, G., Shearwood, V., … Kerr, D. (2019). ToxNav germline genetic testing and PROMinet digital mobile application toxicity monitoring: Results of a prospective single-center clinical utility study—PRECISE study. Cancer Medicine, 8, 6305–6314. https://doi.org/10.1002/cam4.2529
  • Palles, C., Fotheringham, S., Chegwidden, L., Lucas, M., Kerr, R., Mozolowski, G., … Kerr, D. (2021). An evaluation of the diagnostic accuracy of a panel of variants in DPYD and a single variant in ENOSF1 for predicting common capecitabine related toxicities. Cancers, 13, 1497. https://doi.org/10.3390/cancers13071497

Learn More About ToxNav® Advantage

Complete the contact form below and well get back to you. Or, call us now at 513-792-4261