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Noninvasive urine-based biomarker testing can support routine testing for graft dysfunction.
June 7, 2024
By: Michael Barbella
Managing Editor
Life after an organ transplant is not easy—it involves a delicate balance between invasive monitoring and immunosuppression to reduce the risk of rejection, both of which may carry complications. However, a simple, urine-based assay that detects the CXCL10 chemokine may make care more convenient and less invasive for the nearly 250,000 Americans living with a kidney transplant. Thermo Fisher Scientific One Lambda Laboratories, a CLIA facility in Fishers, Ind., has introduced a new CXCL10 testing service, which allows for non-invasive urine sample collection and testing, with results available in as little as 24 hours, providing information faster than currently used tests. Multiple studies have shown that elevated urinary CXCL10 levels are associated with inflammation and early kidney transplant rejection, as outlined in an article in Current Opinion in Organ Transplantation. “Current methods of post-transplant monitoring can represent a significant financial and physical burden for many transplant patients. In keeping with our commitment to health equity, we believe this lower-cost, non-invasive testing option can expand access to care and improve patient adherence, since the sample can be collected at any local clinic,” said Chris McCloskey, director of Transplant Services at Thermo Fisher Scientific. Thermo Fisher’s CXCL10 testing service may supplement current standards of care that may lack specificity or sensitivity, which may lead to unnecessary and invasive biopsies, or produce results too late to influence care, making treating rejection more difficult. This can lead to an aggressive immunosuppression regime, increasing patient morbidity and mortality risks. “We’ve heard directly from patients that invasive biopsies and aggressive immunosuppression to prevent rejection can be incredibly detrimental to their physical and mental health. That’s why we’re leading the way with new non-invasive tests designed to improve patient outcomes and quality of life throughout the transplant journey,” added Tina Liedtky, president of Transplant Diagnostics at Thermo Fisher Scientific. The Thermo Fisher One Lambda Laboratories CXCL10 assay was developed and validated by One Lambda Laboratories. This laboratory developed test (LDT) is used for clinical purposes by the CLIA-certified laboratory performing the test. This test has not been cleared or approved by the U.S. Food and Drug Administration as an in-vitro diagnostic test. Thermo Fisher Scientific Inc. generates annual revenues of more than $40 billion. Its global team delivers nnovative technologies, purchasing convenience, and pharmaceutical services through various brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
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