Thermo Fisher Scientific Introduces New Laboratory Developed Test to Help Transplant Patients Receive the Right Dose of Critical Anti-Rejection Medication Sooner

TacroType™ Pharmacogenetic Test designed to support more personalized tacrolimus dosing, assisting clinical decision-making in solid organ transplant recipients

WEST HILLS, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, today announced the launch of the TacroType™ Pharmacogenetic Test, a new laboratory developed test designed to help inform clinicians on dosing tacrolimus, a commonly prescribed immunosuppressive drug for transplant recipients to lower the risk of rejection.

For transplant recipients, finding the right tacrolimus dose as early as possible can be life-changing. If the dose is too low, the body may reject the new organ. If it is too high, patients face increased risks of injury, infection and other serious complications. Yet patients process tacrolimus differently based in part on their genetics, making standard dosing approaches difficult and often leading to repeated adjustments during the most vulnerable period after transplant.

Thermo Fisher’s new TacroType Pharmacogenetic Test provides genetic insights that can help clinicians better understand how an individual patient is likely to metabolize tacrolimus—supporting more informed dosing decisions from the start and helping reduce the trial-and-error approach that many patients experience today.

The new test addresses this challenge by providing clinicians with actionable genetic insights that can support more personalized tacrolimus dosing decisions. Using a simple buccal swab sample, the test identifies a patient’s CYP3A5 genotype, which influences how quickly tacrolimus is metabolized and how a patient may respond to therapy.

“In transplant medicine, we often see significant variability in how patients respond to tacrolimus, particularly in the early post-transplant period,” said Dr. Keith Melancon, director of the George Washington Transplant Institute. “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.”

When performed prior to transplant, TacroType provides genetic information that may help inform early tacrolimus dosing decisions. This insight enables more informed initial dosing decisions that complement, rather than replace, 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.

“When patients receive a transplant, every day matters,” said Tina Liedtky, president of the transplant diagnostics business at Thermo Fisher Scientific. “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 using rapid, qPCR-based CYP3A5 genotyping services. By providing clinicians with patient-specific information to support tacrolimus dosing decisions, the test may enable clinicians to help patients reach target tacrolimus levels more efficiently and with fewer dose adjustments.

“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,” said Tina Liedtky.

To learn more about TacroType, visit https://www.thermofisher.com/tacrotype.

The TacroType™ Pharmacogenetic Test is a laboratory developed test that is used for clinical purposes by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA) or CE marked in the EU as an in vitro diagnostic test.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.