Prospera™ Lung Transplant Assessment

Casandra

Casandra Test Code NA95669Version 1 (DRAFT)

Performing Lab

Lab NateraLab Test ID N/A

Prospera™ Lung Transplant Assessment

Clinical Use

Use

Prospera™ Lung Transplant Assessment is a noninvasive blood-based test that measures the percentage of donor-derived cell-free DNA (dd‑cfDNA) in a lung transplant recipient’s blood. This serves as an intuitive biomarker for allograft injury, including acute rejection (antibody-mediated rejection, acute cellular rejection, mixed rejection), chronic lung allograft dysfunction (CLAD), and infection. It assists clinicians in surveillance settings to rule in or out active rejection and guide biopsy decision-making, thereby helping reduce the number of invasive procedures required. The test has demonstrated high accuracy and clinical performance, such as an AUC of 0.91 for acute rejection and strong performance metrics in single lung transplant patients. The method leverages a massively multiplexed PCR assay of over 13,000 pan‑ethnic SNPs without requiring prior donor or recipient genotyping. (Supported by the VALID study and SLAM data.)

Special Instructions

The test requires only a single blood draw with no special processing and integrates into clinical workflows through tools like EMRSync and the ProsperaLink program, which offers concierge support including scheduling, coordination of blood draws, and patient assistance. Natera offers financial support programs to work with insurance and reduce financial burden for patients.

Limitations

The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). It is a laboratory-developed test performed in a CLIA-certified, CAP-accredited, and ISO 13485‑certified laboratory. Results should be interpreted by clinicians in conjunction with clinical context; elevated dd‑cfDNA suggests increased risk of rejection but does not definitively diagnose it without clinical correlation and may require confirmatory biopsy.

Test Details