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TacroType™ Pharmacogenetic Test

Dose Smart from the Start

TacroType: genotype-guided tacrolimus dosing

TacroType is a pharmacogenetic test designed to assess genetic variation in the CYP3A5 gene that affects how a transplant patient metabolizes tacrolimus. The test helps provide insights that transplant teams may use to inform dosing decisions from the very first dose.

The clinical challenge: the limits of conventional dosing

Tacrolimus is one of the most widely utilized immunosuppressive drugs provided to transplant recipients today. Yet, early tacrolimus management is challenged by wide, patient-specific variability in drug metabolism, making it difficult to achieve therapeutic levels quickly and safely.1-4 Conventional tacrolimus dosing overlooks significant interpatient differences in metabolism, even among individuals of the same race.5,6 Because tacrolimus has a narrow therapeutic window, acute rejection or injury can result from misdosing.² 

Conventional dosing limitations Impact on care
Relies on reactive adjustments rather than proactive management May lead to prolonged time to reach therapeutic exposure and delay stabilization of immunosuppression
Standard approaches necessitate frequent drug monitoring and clinician-led titration May increase demands on laboratory capacity, clinical staff time, and impact duration of patient stay
Does not account for interpatient variability in tacrolimus metabolism Patients may experience repeated blood draws, dose changes, and uncertainty

Dose smart from the start with TacroType

The TacroType test is a genotyping test that uses a buccal swab or blood sample to characterize CYP3A5 genotype information that healthcare providers may interpret and use to adjust tacrolimus dosing in their patients. The lab categorizes a patient as one of the following:

  • Poor metabolizer
  • Intermediate metabolizer
  • Rapid metabolizer

Our reports use interpretation standards aligned with CPIC (Clinical Pharmacogenetics Implementation Consortium) and DPWG (Dutch Pharmacogenetics Working Group) guidelines, helping ensure transplant teams receive current, evidence-based information.

 

TacroType provides:

Personalization

Metabolism-based guidance using patient-specific genetic information

Smarter dosing

Genetic data to inform early tacrolimus dosing decisions in transplant patients

Precision

Genetic insights move beyond conventional dosing approaches


Actionable insights

Information that may support clinical decision-making

 

The connection between the CYP3A5 gene and tacrolimus metabolism

 

Tacrolimus is predominantly metabolized by the cytochrome P450 3A (CYP3A) enzyme family, with CYP3A5 playing a key role in its oxidative metabolism in the liver and intestine.7 Genetic polymorphisms in the CYP3A5 gene result in differing levels of functional enzyme, which in turn can affect how rapidly tacrolimus is metabolized: individuals with at least one functional CYP3A5*1 allele (expressers) generally have lower dose-adjusted tacrolimus concentrations and may require higher doses to reach therapeutic trough levels compared with non-expressers (e.g., *3/*3 genotypes) who metabolize the drug more slowly.8 This genotype-associated variability partly explains the substantial inter-individual differences in tacrolimus pharmacokinetics seen in transplant recipients, and forms the basis of CYP3A5 genotype-guided dosing recommendations published by the Clinical Pharmacogenetics Implementation Consortium (CPIC).9

The benefits of genotype-guided dosing

Existing third-party studies highlight the potential value of genotype-guided tacrolimus dosing.
 

Faster time to target

A third-party study has suggested that genotype-guided dosing improves achievement of target tacrolimus levels compared with standard dosing.10

Potential cost savings

One decision-tree model cites a ~$17K savings in total institutional costs associated with care when using CYP3A5 genotype-guided dosing for pediatric heart transplant patients.11

Improved patient care

In one published analysis, pharmacogenomic-guided tacrolimus therapy was associated with ~ 6% fewer hospital-days and a lower incidence of adverse drug events, compared to standard dosing.12

A streamlined workflow for timely care

We understand that time is of the essence in the pre-transplant period. TacroType is designed to be non-invasive, with a timely turnaround.

  1. Simple Collection: A buccal swab or a blood sample may be collected at the bedside.
  2. Timely Turnaround: Once the sample reaches One Lambda Laboratories, results are typically released within 48 business hours.
  3. Secure Access: Reports are delivered via a HIPAA-compliant secure portal, with email notifications sent directly to the ordering clinician.
  4. EMR Integration: The concise, one-page report is designed for easy uploading into systems like Epic or Cerner.

 

Frequently asked questions

What is the TacroType Pharmacogenetic Test?

TacroType is a pharmacogenetic test designed to assess genetic variation in the CYP3A5 gene that affects how an organ transplant patient metabolizes tacrolimus.

 

Does TacroType replace conventional trough level or therapeutic drug monitoring?

No, TacroType is an adjunct to conventional dose monitoring methods. It helps provide patient-specific genotype data that may provide information regarding tacrolimus metabolism to aid in initial dosing decisions.

 

What is the expected turnaround time for the TacroType test?

Test results are typically provided within 48 business hours from the time the sample is received. Turnaround times may vary.

 

What is the sample input type for TacroType?

TacroType uses a buccal swab or a blood sample for evaluation.

 

What information does a patient’s TacroType report provide?

This assay detects the CYP3A5 *1, *3, *6, and *7 alleles, which may affect expression of the CYP3A5 enzyme responsible for tacrolimus metabolism. The genotype is used to predict metabolizer phenotype and guide initial tacrolimus dosing. On a report the lab categorizes a patient as one of the following:

  • Poor metabolizer
  • Intermediate metabolizer
  • Rapid metabolizer 

Results should be interpreted by a licensed clinician in conjunction with therapeutic drug monitoring (TDM) and clinical factors.

 

How might this information support transplant patient care?

The TacroType test results can help provide pharmacogenetic information relevant to tacrolimus metabolism. Individuals expressing CYP3A5 may require higher starting doses to achieve therapeutic drug concentrations compared with CYP3A5 non-expressers. Dosing considerations are based on CPIC and DPWG guidelines. Dose adjustments must be guided by measured tacrolimus trough levels, concomitant medications, and clinical response.

 

 

Get started with precision transplant care

Operational excellence: One Lambda Laboratories

 

TacroType is performed by One Lambda Laboratories, a CLIA-certified facility specializing in high-complexity transplant diagnostics. Our laboratory operates with a robust quality management framework to help ensure that the results that you receive are analytically reliable and consistent with validated performance characteristics..

  • Customer Support: Dedicated specialists are available at +1 (463) 234-6725 for onboarding and technical assistance.
  • Easy Ordering: Pre-labeled collection kits and shipping materials are provided to all registered accounts.

Get Started with Precision Transplant Care

 

Incorporate genotype-informed tacrolimus dosing into your institutions protocols.

  • Request a Sample Report: See how phenotype classifications are presented.
  • Schedule a Clinical Overview: Let our specialists walk your team through the validation data.
  • Order Collection Kits: Contact tdx-oll@thermofisher.com to equip your unit.

TacroType: Dose Smart from the Start.

References

  1. Henkel L, Jehn U, Thölking G, Reuter S. Tacrolimus—why pharmacokinetics matter in the clinic. Front Transplant. 2023;2:1160752. doi:10.3389/frtra.2023.1160752.
  2. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet. 2004;43(10):623-653. doi:10.2165/00003088-200443100-00001.
  3. Sikma MA, Hunault CC, van Maarseveen EM, et al. High variability of whole-blood tacrolimus pharmacokinetics early after thoracic organ transplantation. Eur J Drug Metab Pharmacokinet. 2020;45(1):123-134. doi:10.1007/s13318-019-00591-7.
  4. Andrews LM, Li Y, De Winter BCM, et al. Pharmacokinetic considerations related to therapeutic drug monitoring of tacrolimus in kidney transplant patients. Expert Opin Drug Metab Toxicol. 2017;13(12):1225-1236. doi:10.1080/17425255.2017.1395413.
  5. Sanchez-Garcia et al. Am J Transplant. 2022;22(S3). “Tacrolimus Metabolizer Heterogeneity within Caucasian KT Recipients.”
  6. Dyer SC, Austine-Orimoloye O, Azov AG, Barba M, Barnes IF, Barrera-Enriquez VP, et al. Ensembl 2025. Nucleic Acids Res. 2025;53(D1):D948-D957. doi:10.1093/nar/gkae1071.
  7. Thervet E, Loriot MA, Barbier S, et al. Optimization of initial tacrolimus dose using pharmacogenetic testing. Clin Pharmacol Ther. 2010;87(6):721-726. doi:10.1038/clpt.2010.17.
  8. Haufroid V, Mourad M, Van Kerckhove V, et al. The effect of CYP3A5 and MDR1 (ABCB1) polymorphisms on cyclosporine and tacrolimus dose requirements and trough blood levels in stable renal transplant patients. Pharmacogenetics. 2004;14(3):147-154. doi:10.1097/00008571-200403000-00002.
  9. Birdwell KA, Decker B, Barbarino JM, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP3A5 Genotype and Tacrolimus Dosing. Clin Pharmacol Ther. 2015;98(1):19-24. doi:10.1002/cpt.113.
  10. Lloberas N, Grinyó JM, Colom H, et al. A prospective controlled, randomized clinical trial of kidney transplant recipients developed personalized tacrolimus dosing using model-based Bayesian Prediction. Kidney Int. 2023;104(4):840-850. doi:10.1016/j.kint.2023.06.021.
  11. Wang J, Pasternak AL, Maggo S, Mindanao R, Nguyen JQ, Gong CL. CYP3A5 pharmacogenetic testing for tacrolimus in pediatric heart transplant patients: a budget impact analysis. Pharmacogenet Genomics. 2025;35(2):81-86. doi:10.1097/FPC.0000000000000549.
  12. Fragoulakis V, Koufaki MI, Joefield-Roka C, Sunder-Plassmann G, Mitropoulou C. Cost-utility analysis of pharmacogenomics-guided tacrolimus treatment in Austrian kidney transplant recipients participating in the U-PGx PREPARE study. Pharmacogenomics J. 2024;24(2):10. Published 2024 Mar 18. doi:10.1038/s41397-024-00330-5.

For healthcare professional use only. TacroType is a laboratory developed test (LDT) performed by One Lambda Laboratories. This test has not been cleared or approved by the US FDA or CE marked in the EU. Clinical management must include therapeutic drug monitoring and comprehensive patient assessment.