FDA-Approved Black Box (Boxed) Warning Recommends Pharmacogenomic Testing Prior to Common Cancer Treatment: OneOme Provides Test Support with 3-to-4-Day Turnaround Time
Minneapolis, MN — October 10, 2025 — In a significant advancement for patient safety and precision oncology, the U.S. Food and Drug Administration (FDA) updated its black box (boxed) warning for XELODA® (capecitabine) with an recommendation for pharmacogenomic testing prior to treatment. OneOme, cofounded by the Mayo Clinic, is helping healthcare systems and oncologists understand the new requirement and implement compliant testing protocols. The updated boxed warning instructs clinicians:
“Test patients for genetic variants of DPYD prior to initiating XELODA unless immediate treatment is necessary. Avoid use of XELODA in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency.”1
While a highly effective treatment for colon, breast, gastric, esophageal gastroesophageal junction, and pancreatic cancer, XELODA (capecitabine) poses serious risks to patients with DPD (dihydropyrimidine dehydrogenase) enzyme deficiency, which affects approximately 1 in 16 people2. Patients with this deficiency face a 25.6-fold increased risk of fluoropyrimidine-related mortality3 due to variants encoded in the DPYD gene.
OneOme, a leader in pharmacogenomic (PGx) testing, celebrates this patient safety advancement and is positioned to support oncology practices and health systems with rapid, reliable DPYD testing implementation.
“This statement from the FDA on the importance of genetic-guided prescribing is a critical milestone in reducing the risk of toxicity from fluoropyrimidines for patients,” said James Kelley, MD, PhD, Chief Medical Officer at OneOme. “The science behind DPYD testing has been clear for years — now the challenge is efficient implementation and timely turnaround of testing results. That’s exactly what OneOme has been perfecting through our work with cancer centers and health systems worldwide. We want to help cancer patients have the safest treatment possible.”
Preemptive pharmacogenomic testing for DPYD variants can identify patients who are at risk for severe or life-threatening toxicity and empower clinicians to personalize treatment decisions accordingly. But the road to adoption has been a long one.
“We have petitioned the FDA and advocated tirelessly for this boxed warning,” said Karen Merritt, Co-Founder of Advocates for Universal DPD/DPYD Testing. “Patients will now be protected from preventable toxicity — and, in too many cases, preventable deaths. Fluoropyrimidines like XELODA® (capecitabine) and 5-FU can be life-saving for many, but they’re life-threatening for those with DPD deficiency. We’re deeply grateful to everyone who stood with us to make this long-overdue change a reality.”
OneOme offers both a targeted single-gene DPYD test and the RightMed® comprehensive PGx panel, which includes additional genes relevant to chemotherapy agents and supportive care medications. Turnaround times average 3–4 days from sample arrival at the OneOme lab, helping clinicians make timely and informed treatment decisions. Oncology practices should contact OneOme at Oncology@oneome.com or (844) 663-6635 to start DPYD testing within 48 hours. OneOme also offers full pharmacogenomics program implementation support and EHR integration for seamless ordering and results transfer.
About OneOme
OneOme is a leader in precision medicine, providing pharmacogenomic solutions, population-level value-based care analyses, and clinical decision support solutions to health systems, health insurers, and self-insured employers. OneOme aims to improve patient safety, reduce overall cost of care, and improve patients’ health outcomes. Co-founded by the Mayo Clinic, from its headquarters in Minneapolis, OneOme offers its services to clients around the world. For more information, visit https://oneome.com.
Contact: Travis Thompson
Senior Director of Marketing and UX, OneOme, LLC
travisthompson@oneome.com
- XELODA (capecitabine) [package insert]. Greifswald, Germany: CHEPLAPHARM Arzneimittel GmbH; Revised October 2025.
- Jhun EH, Walker JD, Elnashar G, et al. CGE24-094: Recommendation and genotyping discrepancies in DPYD for oncology patients. 2024 Apr 5;22(2.5). Doi: https://doi.org/10.6004/jnchttps://oneome-www.herokuapp.com/admin/pages/229/unpublish/cn.2023.7179.
- Sharma BB, Rai K, Blunt H, et al. Pathogenic DPYD variants and treatment-related mortality in patients receiving fluoropyrimidine chemotherapy: a systematic review and meta-analysis. Oncologist. 2021;26(12):1008-1016.
The statements in this release, including the quoted remarks, are for informational purposes only and reflect the professional opinions of the quoted individual at the time of publication. They are not intended to provide medical advice or to substitute for professional medical judgment. Clinicians should rely on their own clinical expertise and guidelines when making patient care decisions.
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