Natera, a leader in cell-free DNA analysis, announces a powerful new kidney transplant rejection biomarker and study results in collaboration with the University of California, San Francisco, a recognized leader in transplantation care. The data demonstrates superior performance of its massively-multiplexed PCR (mmPCR) technology for detecting acute rejection in kidney transplant patients.
In a blinded, retrospective study, Natera leveraged its validated SNP (Single Nucleotide Polymorphism) technology to measure donor-derived cell-free DNA levels (dd-cfDNA) in 300 plasma samples from 193 unique kidney transplant patients, including 52 patients experiencing acute rejection. The assay was designed based on years of experience in differentiating maternal DNA from fetal DNA in reproductive health. This is the largest patient cohort to date, comparing dd-cfDNA levels to organ biopsies, the current gold standard for organ status assessment.
Natera’s dd-cfDNA assay demonstrated 92% sensitivity in detecting acute rejection, identifying 48 out of 52 affected cases based on a cutoff of 1% dd-cfDNA. This sensitivity compares favorably against competition, which reported only 59% sensitivity in a 2017 study. This performance data suggests the potential of Natera’s assay for use in both rule-in and rule-out applications.
There is a significant unmet need for more accurate non-invasive tools to monitor for allograft rejection. Natera’s assay could help physicians detect rejection events earlier, avoid unnecessary biopsies, and safely optimize immunosuppression levels, potentially lowering the overall costs associated with transplant care. With over 190,000 people living with a kidney transplant in the United States and roughly 20,000 new kidney transplant surgeries performed each year, the kidney transplant market opportunity has been estimated at over $2 billion. Similar dd-cfDNA tests are reimbursed at approximately $2,800. Natera expects to launch a CLIA-certified laboratory developed clinical test in 2019.