One Lambda Exosomes Kidney Transplant Assay

Non-invasive urinary mRNA gene expression assay that enables the detection of all cause rejection

Urinary exosomes are small vesicles released from their parent cells within the kidney. By analyzing exosome mRNA from kidney transplant recipients, allograft status may be evaluated to assess the presence of rejection and discriminate between T-cell mediated rejection (TCMR) and antibody-mediated rejection (ABMR).¹

Potential biopsy risks and issues

While biopsies remain the gold standard for allograft evaluation, they may be invasive, costly, and associated with significant morbidity.³

Key features and benefits

Noninvasive urinary assay: Painless urine test that may be collected same day in clinic
Rejection signatures: Enables the detection of all- cause rejection from no rejection
Early intervention: When early biomarkers such as CXCL10 are elevated and infection has been ruled out, exosome testing may be used to further assess rejection
Fast results: Available in as little as 3-5 days after receipt of sample
Non-biased analysis: Objective result interpretation
Impact on cost of care: Exosome testing may help reduce the need for unnecessary biopsies, thereby lowering overall costs³

Improving outcomes: Conversations with thought leaders in transplantation

Key discussion points include:

Challenges with invasive biopsies
Advantages of noninvasive, convenient, and less expensive biopsies
Additional molecular testing methods beyond detecting solely for rejection

Same sample efficiency for timely intervention

CXCL10 testing

CXCL10 is an inflammatory chemokine, which is indicative of infection and/or rejection when elevated.⁴
Learn more about CXCL10 testing

Exosomal testing

When stored properly, the same urinary sample can conveniently be used for both CXCL10 and exosomal testing. This may allow for faster results, fewer patient office visits, and earlier intervention.²

Learn more about One Lambda Exosomes Kidney Transplant Assay

1. El Fekih, R. et al. Discovery and Validation of a Urinary Exosome mRNA Signature for the Diagnosis of Human Kidney Transplant Rejection. J Am Soc Nephrol. 2021 Apr;32(4):994-1004. doi: 10.1681/ASN.2020060850. Epub 2021 Mar 3. PMID: 33658284; PMCID: PMC8017553.

2. Suthanthiran M, Schwartz JE, Ding R, et al. Urinary-cell mRNA profile and acute cellular rejection in kidney allografts. N Engl J Med. 2013;369(1):20-31. doi:10.1056/NEJMoa1215555.

3. Puttarajappa CM, Mehta RB, Roberts MS, Smith KJ, Hariharan S. Economic analysis of screening for subclinical rejection in kidney transplantation using protocol biopsies and noninvasive biomarkers. Am J Transplant. 2021;21(1):186-197. doi:10.1111/ajt.16150.

4. Liu M, Guo S, Hibbert JM, et al. CXCL10/IP-10 in infectious diseases pathogenesis and potential therapeutic implications. Cytokine Growth Factor Rev. 2011;22(3):121-130. doi:10.1016/j.cytogfr.2011.06.001.

The One Lambda Exosomes Kidney Transplant Assay (EKTrA) is a test that was developed and validated by One Lambda Laboratories. This laboratory-developed test (LDT) is used for clinical purposes by the CLIA-certified laboratory performing the test. This test has not been cleared or approved by the FDA as an in vitro diagnostic test. The One Lambda Exosomes kidney Transplant Assay incorporates ExoTRU™ technology from Exosomes Diagnostics, a Bio-Techne brand.

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