The TacroType test identifies CYP3A5 genotype to help inform tacrolimus dosing decisions in transplant patients.
Thermo Fisher Scientific has launched the TacroType Pharmacogenetic Test, a laboratory developed test designed to help clinicians optimize tacrolimus dosing for transplant recipients by analyzing how patients metabolize the immunosuppressive drug based on their genetics.
The test addresses a challenge in transplant medicine: finding the right tacrolimus dose quickly. If the dose is too low, patients risk organ rejection. If too high, they face increased risks of injury, infection, and other serious complications. Patients process tacrolimus differently based partly on their genetics, making standard dosing approaches difficult and often leading to repeated adjustments during the vulnerable period after transplant.
Using a buccal swab sample, the TacroType test identifies a patient’s CYP3A5 genotype, which influences how quickly tacrolimus is metabolized and how patients may respond to therapy. The test uses rapid, quantitative polymerase chain reaction (qPCR)-based CYP3A5 genotyping services.
“In transplant medicine, we often see significant variability in how patients respond to tacrolimus, particularly in the early post-transplant period,” says Dr Keith Melancon, director of the George Washington Transplant Institute, in a release. “Having pharmacogenetic information upfront can help inform initial dosing decisions, reduce the need for repeated adjustments, and support more consistent immunosuppressive management when patients are most vulnerable.”
Supporting Personalized Dosing Decisions
When performed prior to transplant, TacroType provides genetic information that may help inform early tacrolimus dosing decisions. The test complements ongoing therapeutic drug monitoring. By moving beyond conventional dosing approaches, clinicians may be able to reduce the risk of adverse effects while supporting better long-term graft and patient outcomes.
The test may enable clinicians to help patients reach target tacrolimus levels more efficiently and with fewer dose adjustments by providing patient-specific information to support dosing decisions.
“When patients receive a transplant, every day matters,” says Tina Liedtky, president of the transplant diagnostics business at Thermo Fisher Scientific, in a release. “The TacroType test gives clinicians valuable information from the start and supports more effective, personalized care for patients during a critical period.”
The TacroType test is offered as a one-time pharmacogenetic assessment. The test is performed by Clinical Laboratory Improvement Amendments-certified laboratories and has not been cleared or approved by the Food and Drug Administration or CE marked in the European Union as an in vitro diagnostic test.
“This new test reflects the growing role of pharmacogenetics in transplant medicine. It offers clinicians an additional data point to help manage immunosuppressive therapy to each patient’s unique needs,” says Liedtky in a release.
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