Natera Publishes New Clinical Trial Results, Reducing Lung Transplant Biopsies

Natera announced the publication of a new prospective clinical trial in Transplantation Direct. The study, which was conducted by The Ohio State University Wexner Medical Center, was initiated to explore whether donor-derived cell-free DNA surveillance, and specifically Prospera-guided monitoring, could reduce the number of invasive biopsies for patients following lung transplantation. As transplant volumes increased at OSU-WMC, the center launched a quality assurance and performance improvement initiative to evaluate whether the Prospera test could allow them to safely eliminate the 9-month surveillance biopsy. In the study, 78 lung-transplant recipients were monitored with the Prospera test for one year post-transplant. Physicians chose to omit the 9-month biopsy in ~75% of patients with low-risk Prospera results. For these patients over the ensuing 3 months, there was no significant difference in acute rejection rates, spirometry indices, or donor-specific antibodies compared to patients who underwent the procedure. At one year post-transplant, approximately 95% of patients who omitted the 9-month biopsy did not have acute rejection that needed any treatment. Patients who omitted the 9-month biopsy maintained lung function and immunologic stability similar to those who underwent the procedure.