June 3rd, 2023
Dear Transplant Professional,
In pursuit of our commitment and investment to transplant innovation, CareDx is pleased to inform you of key enhancements to the AlloSure® Kidney Test and Report to help you manage kidney transplant patients.
AlloSure Relative Change Value (RCV):
Starting June 5th, AlloSure RCV will be displayed with each AlloSure result, making it readily available to support clinical decisions.
AlloSure Kidney is the only dd-cfDNA test validated to detect allograft injury based on sequential testing using RCV. Providers now have two clinically validated measures – the AlloSure Result and AlloSure RCV – for early detection of allograft injury and rejection1,2.
In addition to the placement and calculation of Relative Change Value (RCV) between sequential results, the AlloSure Test Report will also feature changes in the lower Limit of Detection.
Reduction of Lower Limit of Detection (LOD):
Starting June 5th, AlloSure LOD will improve from a limit of 0.12% to 0.04%. The change enhances AlloSure’s analytical sensitivity by improving the lowest concentration of donorderived circulating cell-free DNA that AlloSure Kidney can reliably detect down to 0.04% (unrelated donor) or 0.08% (related), enhancing AlloSure’s analytical sensitivity. By lowering the LOD, AlloSure now enables providers to manage patients whose AlloSure results are as low as 0.04%.
With this improvement, AlloSure will have the lowest LOD of any commercially available ddcfDNA test for kidney allograft injury or rejection, making it the most sensitive commercially available test.
A sample report follows and demonstrates these new improvements.
CareDx is committed to continuous improvement to deliver high-quality AlloSure results to support clinical decision making.
Thank you for entrusting us to support you in managing your kidney transplant patients.
Sincerely,
The CareDx Team
Your Partners in Transplant Care
References
1. Bloom et al. JASN 2017
2. Bu et al. KI 2021
Frequently Asked Questions
Why is the RCV for AlloSure Kidney calculated only above 0.20%?
- The validation data for AlloSure Kidney RCV calculation is available only above 0.20% – NPV for AlloSure Kidney at 0.21% is 95% from the DART study.
What is Limit of Detection (LOD) and why is it important?
- The LOD is the lowest concentration of donor-derived, circulating cell-free DNA that AlloSure Kidney can reliably detect, now down to 0.04% (unrelated donor) or 0.08% (related), enhancing AlloSure’s analytical sensitivity.
- With lower LOD, AlloSure tests now enable the clinicians to longitudinally monitor patients whose results currently fall above 0.04%.
- With this improvement, AlloSure will have the lowest LOD, making it the most sensitive assay compared to any other commercially available dd-cfDNA options in the market.
Does this change any clinical or decision thresholds for AlloSure Kidney?
- This improved LOD does NOT impact the thresholds clinicians reference for AlloSure Kidney, since there is no change to the accuracy of measurements above 0.12%. The improvements simply enable quantitative measurement at lower levels.
How do I see this enhancement on the report?
- The reports will now show values going down to 0.04% from the current 0.12%. A sample report follows that showcases these changes.
What do I need to do in order to get this enhancement?
- To prepare your institution for these changes, we request that you update your Laboratory Information System (LIS) and Electronic Medical Record (EMR) with the new LOD range & Test Report for AlloSure. This will ensure that the new LOD is appropriately incorporated into the interpretation of test results and prevent any potential confusion or errors.
- On our end, we will automatically turn on the new LOD report format for AlloSure tests received via PDF, Fax, CarePortal, Web Portal, and EMR systems on June 5th.
Sample AlloSure Kidney Report
