Prospera™ Lung Transplant Assessment
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
Not provided.
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.
Methodology
PCR-based (PCR)
Biomarkers
Donor‑derived cell‑free DNA fraction
Signature
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
Not provided
Minimum Volume
Not provided
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