NEW YORK – Natera announced Wednesday that its Prospera Lung test has received coverage from the US Centers for Medicare and Medicaid Services for single lung transplant patients in the surveillance setting.
The firm's test met the requirements under CMS's Molecular Diagnostic Services Program and is covered under Medicare administrative contractor Noridian Healthcare Solutions' local coverage determination for molecular testing for solid organ allograft rejection.
The test was validated for single lung transplant (SLT) patients in the Single Lung Allograft Monitoring study and showed "excellent performance," Natera said in a statement. The assay was able to distinguish rejection, infection, and chronic lung allograft disease from stable patients with area under the receiving operator curve of 0.85. The test had a sensitivity of 78 percent, specificity of 85 percent, and negative predictive value of 97 percent.
The test uses Natera's single-nucleotide-based massively multiplexed PCR technology to identify allograft rejection from a blood sample without the need for prior donor or recipient genotyping.
"We are pleased to be the first and only [donor-derived cell-free DNA] test validated and approved by CMS for SLT patients," David Ross, senior medical director for lung transplant at Natera, said in a statement. "Lung transplant survival is among the worst compared to other organs, even more so for SLT patients where the median survival is just 4.7 years post-transplant and with higher risk for both acute and chronic rejection. It is critical to patient care that SLT patients have the option for noninvasive monitoring to avoid biopsy complications in these challenging cases."
Prospera Lung was launched in 2022 and received CMS coverage for double-lung transplant patients in 2023.