Prospera Transplant Assessment

Casandra

Casandra Test Code NA31335Version 1 (DRAFT)

Performing Lab

Lab NateraLab Test ID N/ACPT Code 81479

Prospera Transplant Assessment

Clinical Use

Use

Prospera Transplant Assessment is a non‑invasive blood test that measures the fraction of donor‑derived cell‑free DNA (dd‑cfDNA) in the recipient’s blood using SNP‑based massively multiplexed PCR technology, without requiring prior donor or recipient genotyping. It is intended to help assess the risk of active transplant rejection—such as antibody‑mediated or T cell‑mediated rejection—by aiding providers in ruling in or out rejection and guiding the need for diagnostic testing or biopsy in kidney transplant recipients. The test has been clinically and analytically validated regardless of donor relatedness, rejection type, and clinical presentation, and has been shown to predict rejection up to two to five months before biopsy‑proven events in the ProActive study registry. The test is not FDA‑cleared or approved and is performed in a CLIA‑certified, CAP‑accredited laboratory.

Special Instructions

Ordering requires the completion and submission of a patient history form included in the Prospera collection kit, and insurance information must be provided. The test is available as a send‑out to qualified clients through ARUP Laboratories. Specimens must be collected using the Prospera Transplant Assessment Collection Kit (ARUP Supply #55552).

Limitations

False positives and false negatives can occur. A high dd‑cfDNA fraction is associated with higher rejection risk but requires clinical correlation; a low fraction does not fully exclude active rejection or other kidney injuries. Test results should be interpreted in the context of clinical data. The test is not indicated for pediatric patients under ~100 pounds, pregnant patients, those less than two weeks post‑transplant, identical twin donors, allogeneic stem cell transplant recipients, or recipients of non‑kidney organ transplants.

Test Details

New York Approved