Natera is a pioneer and global leader in cell-free DNA testing, today announced the achievement of key recruitment milestones in the ProActive registry study and success in the Prospera early access program.
The ProActive study will follow 3,000 kidney transplant patients over a three to five year period to examine the utility of the Prospera donor-derived cell-free DNA (dd-cfDNA) transplant assessment test to accurately identify organ rejection. The study is outpacing Natera’s enrollment expectations with 18 top transplant centers already activated, more coming online in the near future, and 145 patients currently enrolled.
“The ProActive trial is a large, prospective registry study designed to provide valuable insights on clinical biomarkers, biopsy usage, and clinical outcomes. Participation by top transplant centers in the U.S. is leading to increasing enrollment and accumulation of important data. It is notable this is happening even during these difficult times for our transplant patients and centers during the COVID-19 pandemic, demonstrating the fortitude and commitment of transplant professionals to the future of the field. I am confident this trial will improve the care of our patients and look forward to the results,” said Jonathan Bromberg, M.D., Professor of Surgery and Microbiology and Immunology, Vice-Chair for Research at the University of Maryland School of Medicine, and Principal Investigator of the ProActive study.
In the Prospera early access program, Natera has received tests from 45% of the top 50 and 37% of the top 100 transplant centers by volume. “The strong interest in Prospera and the significant number of top centers ordering tests during the early access program reflects a desire for more accurate, non-invasive testing methods, which Prospera fulfills through its ability to identify rejection with higher accuracy than first-generation dd-cfDNA tests and current standards of care,”1,2 said Paul Billings, M.D., Ph.D., Chief Medical Officer and SVP of Medical Affairs at Natera.