Thermo Fisher Scientific One Lambda Laboratories, a clinical laboratory improvement amendments (CLIA)-certified facility in Fishers, Indiana, has introduced a new CXCL10 testing service.
The new testing service is intended to facilitate a non-invasive urine sample collection and testing and provide results within 24 hours, faster than currently used tests.
According to several studies, elevated levels of CXCL10 in urine are associated with inflammation and early kidney transplant rejection.
Thermo Fisher said that its CXCL10 testing service, developed, and validated by One Lambda Laboratories, enhances the current standards of care.
It addresses the current standards of care’s lack of specificity or sensitivity, unnecessary and invasive biopsies, and late results that influence care and treating rejection more difficult.
Thermo Fisher Scientific transplant services director Chris McCloskey said: “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.”
According to the company, the life of organ transplant recipients involves a delicate balance between invasive monitoring and immunosuppression to reduce the risk of rejection.
Invasive monitoring and immunosuppression both are linked to complications.
Its new simple, urine-based assay that detects the CXCL10 chemokine will make care more convenient and less invasive for the nearly 250,000 US patients with a kidney transplant.
The laboratory-developed test (LDT), intended for use by CLIA-certified laboratories, has not been approved by the US Food and Drug Administration (FDA) as an in vitro diagnostic test.
Thermo Fisher Scientific transplant diagnostics president Tina Liedtky said: “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 proud to be at the forefront of industry, leading the way with new non-invasive tests designed to improve patient outcomes and quality of life throughout the transplant journey.”
Recently, Thermo Fisher Scientific signed an agreement with US-based diagnostic tools and bioactive reagents provider Bio-Techne, to distribute its products in Europe.
The agreement enables a range of Bio-Techne’s antibodies, proteins, immunoassay kits, reagents, and enzymes to reach European laboratories and research institutions.
