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Confidently monitor your kidney transplant patients with VitaGraft™ Kidney.

Fast turnaround time. Improved outcomes. 

 

VitaGraft KidneyTM lets you know sooner to act faster

Practical. Fast. Evidence-based.

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Rule out suspected injury

86% of unnecessary biopsies triggered by elevated plasma creatinine in stable patients may be avoided using VitaGraft Kidney dd-cfDNA technology.1

Taper immunosuppression

Better personalize the minimum effective dose for each patient.1

Detect injury early

Use VitaGraft Kidney with improved turnaround times in for-cause
clinical scenarios.1

Pioneering patient care together. Clear, concise results.

VitaGraft Kidney

is a non-invasive, blood-based transplant monitoring test that quantifies the concentration of donor-derived cell-free DNA (dd-cfDNA) following kidney transplantation.

  • Optimized turnaround time
  • Negative predictive value (NPV) of 91%*1
  • Highly precise droplet-digital polymerase chain reaction (ddPCR) technology
  • A personalized assay for each patient
  • Absolute and fractional quantification reported

*Calculate at a 25% prevalence using biopsy-proven samples.

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Process overview

Step 1

Post-transplant
patient blood
sample drawn*

Step 2

Send samples to Oncocyte’s CAP/CLIA certified laboratory

Step 3

dd-cfDNA measured using dd-PCR

Step 4

Risk for active
rejection reported

*The initial test requires a one-time urine sample in addition to blood to set the assay for the patient. Thereafter, we require blood only for all subsequent tests.

Manage the risk of transplant rejection

VitaGraft Kidney technology

Donor-derived cfDNA is used as a biomarker to assess organ health and rejection risk status. Through ddPCR, VitaGraft Kidney determines a set of single-nucleotide polymorphisms (SNPs) specific to each patient.2

A subset of SNPs are selected from “scientifically-validated” commonly-shared SNPs across the global population. This allows for differentiation between the donor and recipient cfDNA. Using the selected personalized assay, dd-cfDNA is measured using absolute and relative quantification.2

With VitaGraft Kidney’s strong performance of 92% diagnostic specificity, 91% NPV,* and fast
turnaround time, injury can be assessed with confidence1.

*Calculated at a 25% prevalence using biopsy-proven samples.

Organ health and dd-cfDNA

Order VitaGraft Kidney

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Clinical evidence

  • Validation Data
  • Guide Immunosuppression
  • Absolute Quantification Performance

Receiver Operating Characteristic (ROC) curve comparison of dd-cfDNA (cp/mL) and dd-cfDNA (%) shows superior performance of absolute amount1

  • Validated in 345 kidney transplant patients with over 2,570
    samples for up to 5 years following transplantation1,3
  • For long-term surveillance, measurement of absolute dd-cfDNA concentrations appears to be superior to percentages to minimize false positive results1,3
    • Area Under the ROC (AUCROC) curve for absolute quantity of dd-cfDNA (cp/mL) showed an increase of 14% compared to relative quantification of dd-cfDNA (%) in discriminating stable phase (n=395) from biopsy-proven rejection (n=22)1
    • High NPV of 91%* to rule out injury1

*Calculated at a 25% prevalence using biopsy-proven samples.
n = number of samples

Association between increased dd-cfDNA values and low tacrolimus concentrations following kidney transplantation1

  • dd-cfDNA (cp/ml) may aid clinical care in finding the minimum effective immunosuppressive dose for kidney transplant patients1
    • There were a significantly higher proportion of samples with elevated dd-cfDNA (cp/mL) and lower tacrolimus levels (<8µg/L) compared to the samples with higher tacrolimus concentrations1

Time-related stability of dd-cfDNA (cp/mL) compared to other markers for up to five years following kidney transplantation3

  • Absolute dd-cfDNA (cp/mL) remained stable during the 12-60 month study period, along with median plasma creatinine and estimated Glomerular Filtration Rate (eGFR), confirming that absolute quantification accurately indentified the 303 stable kidney transplant patients3
  • Total cfDNA median values steadily decreased over time resulting in statistically significant increased dd-cfDNA (%) that was independent of graft health3
    • This decrease can be explained by a pharmacological effect of reducing the dosage of calcineurin inhibitors (CNIs) (e.g., tacrolimus)3

VitaGraft resource library

Kidney Clinical Summary

Oellerich M, et al. (2019)

Absolute quantification of donor-derived cell-free DNA as a marker of rejection and graft injury in kidney transplantation: Results from a prospective observational study. Am J Transplant 19(11):3087.

Read More

Kidney Clinical Summary

Schütz E, et al. (2020)

Time-dependent apparent increase in dd-cfDNA percentage in clinically stable patients between one and five years following kidney transplantation. Clin Chem 66(10):1290.

Read More

Kidney Information Sheet

Intro to VitaGraft Kidney

For nephrologists, surgeons, and clinical transplant professionals.

Read More

FAQs

Who can I contact with questions?
  • Oncocyte Main Phone: 949-409-7600
  • Customer Experience Information:
  • Transplant Direct Phone: 844-384-6440
What is VitaGraft?
  • VitaGraft is a blood-based transplant monitoring test that quantifies the concentration of donor-derived cell-free DNA (dd-cfDNA) following liver and kidney transplantation.
  • Increased amounts of dd-cfDNA following transplantation may indicate organ damage and possible rejection.
  • VitaGraft is not indicated for patients who are: pregnant, less than two weeks post-transplant for monitoring, recipients of an allograft from an identical twin, recipients of an allogenic stem cell transplant, recipients of a non-liver organ transplant, or recipients of multiple organ transplants.
What are the differences between VitaGraft Liver and VitaGraft Kidney?
  • VitaGraft Liver and VitaGraft Kidney have different diagnostic thresholds (i.e., the amount of dd-cfDNA that may indicate organ damage differs between the two organs).
    • Kidney diagnostic thresholds: 0.5% and 50cp/mL
    • Liver diagnostic thresholds: 10% and 1000cp/mL
  • Although both tests quantify dd-cfDNA using blood, VitaGraft Kidney requires a urine sample for the initial test to set the assay for the patient. Thereafter, we require blood only for all subsequent tests.
What is the required timeframe for blood samples to be processed?
  • Blood samples must be processed within 7 days of collection.
What is the turnaround time?
  • Less than 48 hours.
How do I request the VitaGraft test?
  • Through the online portal or by filling out a paper Test Requisition Form (TRF). Please contact your Local Representative or Oncocyte Customer Experience (844-662-6298) for any questions.
Does Oncocyte offer payment plans for the VitaGraft test?
  • We offer zero interest payment plans for balances over $99. The payment plans are for 3 to 6 months.
What is an Explanation of Benefit (EOB) and what amount will it include?
  • An EOB is a statement from your health insurance plan describing what costs it will cover for medical care or products you’ve received. It is not a bill.
How can I pay my bill?
  • Patients can make a payment by check or credit card (accepted types: VISA, Mastercard, and Discover). We accept credit card payments over the phone. Checks can be sent to the lock box address: Oncocyte Corporation, PO Box 120293, Dallas, TX 75312-0293. We send statements with the mailing address and phone numbers to the patient every 30 days for 3 cycles.

Test We identify informative SNPs selected from a set of predefined SNPs. The informative SNP set for each patient is defined on the first-contact sample (selection). For all subsequent tests (monitoring), we measure the concentration of dd-cfDNA and provide a rejection risk report.

Order VitaGraft Kidney for your patients following kidney transplantation. Reach out to Oncocyte’s Customer Service for ordering details.

We’re here to help

Oncocyte Customer Service can answer any questions you have. Please contact us at:

Phone: 844-621-8880
[email protected]

We do not want cost to be a barrier for testing, patients can call (844-621-8880) or fax (844-584-3467) to see if they qualify for our financial assistance program.

References

1. Oellerich M, Shipkova M, Asendorf T, et al. (2019) Absolute quantification of donor-derived cell-free DNA as a marker of rejection and graft injury in kidney transplantation: Results from a prospective observational study. Am J Transplant 19(11):3087. 2. Beck J, Bierau S, Balzer S, et al. (2013) Digital droplet PCR for rapid quantification of donor DNA in the circulation of transplant recipients as a potential universal biomarker of graft injury. Clin Chem 59(12):1732. 3. Schutz E, Asendorf T, Beck J, et al. (2020) Time-dependent apparent increase in dd-cfDNA percentage in clinically stable patients between one and five years following kidney transplantation. Clin Chem 66(10):1290.

©2023 Oncocyte, Inc. All Rights Reserved. The VitaGraft Kidney Test has been developed and its performance characteristics determined by Oncocyte. The VitaGraft Kidney Test has not been cleared or approved by the US Food and Drug Administration (FDA). Oncocyte’s laboratory offering the VitaGraft Kidney Test is CAP-accredited and CLIA-certified.

 

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