LOD AlloSure Lung

June 3^rd, 2023

Dear Transplant Professional,

In pursuit of our commitment to and investment in transplant innovation, CareDx is pleased to inform you of key enhancements to the AlloSure^{^®} Lung Test and Report to help you manage Lung transplant patients.

Starting Monday, June 5^th, the lower Limit of Detection [LOD] for AlloSure will be reduced from its current 0.12% to 0.04%.

The LOD is the lowest concentration of donor-derived circulating, cell-free DNA that AlloSure Lung can reliably detect, now down to 0.04%, enhancing AlloSure’s analytical sensitivity. By lowering the LOD, AlloSure test now enables providers to longitudinally monitor patients whose results currently fall below 0.12%.

With this improvement, AlloSure will have the lowest LOD of any commercially available dd-cfDNA test for lung allograft injury or rejection, making it the most analytically sensitive commercially available dd-cfDNA assay.

We are providing a few frequently asked questions below to help you understand how this change will benefit you. We are also providing a sample report below that highlights these new improvements. If you have any further questions, please feel free to reach out to your local CareDx representative or Medical Science Liaison.

Thank you for entrusting us to support you in managing your lung transplant patients.

Sincerely,

The CareDx Team
Your Partners in Transplant Care

Frequently Asked Questions

What is Limit of Detection (LOD) and why is it important?

The LOD is the lowest concentration of donor-derived, circulating cell-free DNA [ddcfDNA] that AlloSure Lung can reliably detect, now down to 0.04%, enhancing AlloSure’s analytical sensitivity.
With lower LOD, AlloSure test now enables providers to longitudinally monitor patients whose AlloSure results currently fall below 0.12%.
With this improvement, AlloSure will have the lowest LOD, making it the most analytically sensitive test compared to any other commercially available dd-cfDNA options in the market.

Does this change any clinical or decision thresholds for AlloSure tests?

This improved LOD does NOT impact the thresholds clinicians reference for AlloSure Lung, since there is no change to the accuracy of measurements above 0.12%. The improvements simply enable quantitative measurement at lower levels.
This means that there are NO CHANGES in the way AlloSure Lung should be interpreted.

How do I see this enhancement on the report?

The reports will now have values going down to 0.04% from the current 0.12%. A sample report follows below that highlights these changes.
However, as mentioned above, there are NO CHANGES in the threshold for the test. This will be showcased in the report through the addition of the following statement: Improved reportable range 0.04% – 16% (previously 0.12% – 16%). Thresholds associated with rejection have NOT changed.

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.
CareDx will automatically turn on the new LOD report format for AlloSure tests received via PDF, Fax, CarePortal, Web Portal, and EMR systems on June 5^th.

What is AlloSure Lung and why is lower LOD important?

AlloSure Lung is a reliable, non-invasive measure of direct allograft injury for Lung transplant recipients. AlloSure Lung can quantify increasing levels of dd-cfDNA, serving as a leading indicator of graft injury.
With lower LOD, AlloSure test now enables providers to longitudinally monitor patients whose AlloSure results currently fall above 0.04%, enhancing AlloSure’s analytical sensitivity.