Natera Announces Its Prospera Lung Test Has Met Coverage Requirements From The Centers For Medicare & Medicaid Services' Molecular Diagnostics Services Program For Single Lung Transplant Recipients; This Coverage Applies To SLT Patients In The Surveillance Setting.

Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA and genetic testing, today announced that its Prospera Lung test has met coverage requirements from the Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostics Services (MolDX) Program for single lung transplant (SLT) recipients. This coverage applies to SLT patients in the surveillance setting.

SLT patients make up ~20% of all U.S. lung transplants1. These patients are at an increased risk for acute rejection and also for complications from invasive procedures like biopsies due to common factors including advanced age, frailty, comorbidities, and functional dependency on a single lung. This creates an increased need for non-invasive monitoring solutions, like Prospera Lung.

The performance of Prospera Lung for SLT patients was published earlier this year from the Single Lung Allograft Monitoring (a.k.a. SLAM) study, the largest study of commercial donor-derived cell free DNA (dd-cfDNA) tests in SLT to-date. The data demonstrated excellent performance for Prospera in distinguishing rejection, infection, and chronic lung allograft disease (CLAD) from stable patients with an AUC-ROC of 0.85. These results are on par with Prospera's outstanding performance in double-lung transplants, and can ultimately provide confidence to rule out rejection, highlighted by a sensitivity of 77.8%, specificity of 84.6%, and a negative predictive value (NPV) of 96.8%.