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Transplant Rejection Allograft Check (TRAC™) donor-derived cell-free DNA (dd-cfDNA) assay
Clinical Genetic Test
Help
offered by
Transplant Genomics Inc.
View lab's test page
LinkOut
GTR Test Accession: Help GTR000597639.1
NYS CLEP
Last updated in GTR: 2022-09-28
View version history
Last annual review date for the lab: 2023-08-14 LinkOut
At a Glance
Test purpose: Help
Diagnosis
Conditions (1): Help
Kidney Transplant Rejection
Chromosomal regions/ Mitochondria (1): Help
Human genome
Methods (1): Help
Molecular Genetics - RNA analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Kidney transplant patients
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Transplant Genomics Inc.
View lab's website
View lab's test page
Test short name: Help
TRAC
Manufacturer's name: Help
Viracor (marketed and sold by sister company, Transplant Genomics)
Specimen Source: Help
Who can order: Help
  • Licensed Physician
Test Order Code: Help
30876
View other test codes
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

How to Order: Help
Via Retriever (web-based ordering) or Viracor Customer Service Contact Client Services at 1-800-305-5198 prior to ordering, this test requires special tubes for collection
Order URL
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Lab contact for this test, Contact policy, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Chromosomal regions/Mitochondria Help
Total chromosomal regions/mitochondria: 1
Chromosomal region/Mitochondrion Associated condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
RNA analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis
Target population: Help
Kidney transplant patients
View citations (4)
  • Gielis EM, Ledeganck KJ, De Winter BY, Del Favero J, Bosmans JL, Claas FH, Abramowicz D, Eikmans M. Cell-Free DNA: An Upcoming Biomarker in Transplantation. Am J Transplant. 2015;15(10):2541-51. doi:10.1111/ajt.13387. Epub 2015 Jul 16. PMID: 26184824.
  • De Vlaminck I, Martin L, Kertesz M, Patel K, Kowarsky M, Strehl C, Cohen G, Luikart H, Neff NF, Okamoto J, Nicolls MR, Cornfield D, Weill D, Valantine H, Khush KK, Quake SR. Noninvasive monitoring of infection and rejection after lung transplantation. Proc Natl Acad Sci U S A. 2015;112(43):13336-41. doi:10.1073/pnas.1517494112. Epub 2015 Oct 12. PMID: 26460048.
  • Grskovic M, Hiller DJ, Eubank LA, Sninsky JJ, Christopherson C, Collins JP, Thompson K, Song M, Wang YS, Ross D, Nelles MJ, Yee JP, Wilber JC, Crespo-Leiro MG, Scott SL, Woodward RN. Validation of a Clinical-Grade Assay to Measure Donor-Derived Cell-Free DNA in Solid Organ Transplant Recipients. J Mol Diagn. 2016;18(6):890-902. doi:10.1016/j.jmoldx.2016.07.003. Epub 2016 Oct 07. PMID: 27727019.
  • Biological Variation of Donor-Derived Cell-Free DNA in Renal Transplant Recipients: Clinical Implications. Bromberg JS, et al. J Appl Lab Med. 2017;2(3):309-321. doi:10.1373/jalm.2016.022731. PMID: 33636851.
Recommended fields not provided:
Clinical validity, Clinical utility, What is the protocol for interpreting a variation as a VUS?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Comments: Help
whole genome sequencing, 0.3-0.5x average read depth
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
To establish a clinical cutoff for for Viracor’s TRAC® Kidney dd-cfDNA assay, a total of 77 plasma samples collected from kidney transplant recipients were tested by the analytically validated method. The patient samples tested were obtained from a biorepository source. Of the 77 samples tested, 58 were characterized by the … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
No
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: Not Applicable
NYS CLEP Approval: Help
Number: 26D0983643 PFI: 8091
Status: Approved
Additional Information
Consumer resources:

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