Natera, Inc. announced that its Prospera Lung test has met coverage requirements from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services (MolDX) Program. This new coverage applies to single lung transplant (SLT) recipients in the surveillance setting.
SLT patients represent approximately 20% of all U.S. lung transplants and face increased risks for acute rejection and complications from invasive procedures like biopsies. This coverage addresses a critical need for non-invasive monitoring solutions in this vulnerable patient population.
The performance of Prospera Lung for SLT patients was validated in the Single Lung Allograft Monitoring (SLAM) study, demonstrating an AUC-ROC of 0.85. The test showed a sensitivity of 77.8%, specificity of 84.6%, and a negative predictive value (NPV) of 96.8% in distinguishing rejection, infection, and chronic lung allograft disease from stable patients.
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