Natera Inc (NASDAQ: NTRA), a provider of cell-free DNA and genetic testing, announced on Wednesday that its Prospera Lung test has received Medicare coverage under the CMS Molecular Diagnostics Services (MolDX) Program for single lung transplant (SLT) recipients in surveillance settings. SLT patients account for approximately 20% of lung transplants in the US and face heightened risks of acute rejection and complications from invasive biopsies due to age, comorbidities and reliance on a single lung.

Prospera Lung, validated in the SLAM study, the largest to date for donor-derived cell-free DNA (dd-cfDNA) testing in SLT, demonstrated high accuracy in detecting rejection, infection and chronic lung allograft disease (CLAD) with an AUC-ROC of 0.85. Its sensitivity of 77.8%, specificity of 84.6%, and negative predictive value (NPV) of 96.8% provide a reliable non-invasive alternative to biopsy. These results align with its performance in double-lung transplants, for which it received Medicare coverage in 2023.

Launched in 2022, Prospera Lung uses Natera's SNP-based massively multiplexed PCR technology to measure dd-cfDNA levels in recipients' blood, identifying allograft rejection without prior genotyping. The test is now adopted by over half of US lung transplant centers.

Natera focuses on oncology, women's health and organ health. Its diagnostics are supported by over 250 peer-reviewed publications and validated through ISO 13485-certified, CAP-accredited and CLIA-compliant laboratories in Texas and California.