Aranscia® solutions help oncologists comply with new FDA warning label requiring
DPYD genetic testing in patients receiving select chemotherapies
HOUSTON, Oct. 16, 2025 /PRNewswire/ — Oncologists and pharmacy experts are reacting to last week’s Food and Drug Administration warning that requires genetic testing on patients receiving the common chemotherapy drug capecitabine (Xeloda®) – and are actively seeking technologies that allow them to leverage these test results within their clinical workflows. Aranscia, a leading provider of personalized, precision diagnostics and clinical workflow solutions, equips providers with discrete diagnostic, clinical decision support, and software solutions. These are designed to help identify patients who harbor DPYD variants, streamline the test-ordering workflow, and deliver actionable reports and insights at the point of care.
“A concerning number of patients have difficulty metabolizing capecitabine and fluorouracil, which are commonly used to treat a wide range of cancers,” noted Houda Hachad, PharmD and Vice President of Clinical Operations at Aranscia. The DPYD gene produces dihydropyrimidine dehydrogenase (DPD), an enzyme responsible for metabolizing these medications. DPYD gene variants may cause DPD deficiencies, leading to dangerously high or toxic accumulations of these drugs.
Between 3% and 8% of the general population carries one copy of variants associated with lower DPD metabolizing capacity.
Early in October, the FDA updated the label for Genentech’s Xeloda (capecitabine), explicitly requiring providers to assess patient genetic risk for severe toxicities from this commonly prescribed chemotherapy prior to treatment. The so-called “black box warning” on the Xeloda label now states: “Serious adverse reactions or death may occur in patients with complete DPD deficiency. 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.”
“Advocates for pre-treatment DPYD testing believe that the FDA will likewise revise labelling for fluorouracil to require testing,” adds Dr. Hachad.
“A number of diagnostic laboratories offer standalone and panel solutions for DPYD testing,” she continues, “but providers are encountering workflow barriers that impede their ability to adopt this testing as standard of care and to access results when and where they need them.” This is especially critical since testing is required before important treatment is initiated.
While some leading academic medical centers have successfully developed technological solutions in-house, she said, other health systems and community oncology centers – where 80 percent of cancer patients are treated – may lack the time, personnel, and financial resources to build a ground-up solution. The Aranscia software portfolio (which includes 2bPrecise®, Spesana, and YouScript®) can accommodate the “round trip” testing workflow from identifying patients, to ordering the appropriate test, to delivering timely reports, and surfacing vital information via alerts and notifications within the patient’s electronic medical record.
“Ensuring fast and efficient rapid access to high-quality testing, along with providing oncologists with actionable insights before treatment, is crucial,” Dr. Hachad emphasized. “Furthermore, Aranscia’s capability to integrate and unify siloed genomic results from various cancer diagnostics into clinically meaningful intelligence supports organizations as they manage diverse DPYD test results (e.g., incidental), as well as other important cancer biomarkers.”
About Aranscia
Aranscia delivers world-class diagnostic software, services, and testing innovations that help clinicians improve care outcomes. The Aranscia portfolio of companies, which includes 2bPrecise, AccessDx Laboratory, Spesana, and YouScript, has extensive practical expertise in molecular diagnostics, genomics, and digital-first clinical workflows. Aranscia enables clinical organizations to effectively utilize precision diagnostics for turnkey programs in fields such as pharmacogenomics, infectious disease management, precision oncology, and genetic screening. With a dual focus on simplicity and scalability, Aranscia’s portfolio companies are the ideal partner for long-term, value-based precision medicine initiatives. For more information, please visit www.aranscia.com.
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