For several years, both CareDx and Natera have offered transplant patients the chance to detect organ rejection earlier, by quantifying the release of donor DNA from damaged graft cells.
See news on the DEFINE-HT trial (Natera), presented an an international transplant meeting this past week. Natera's share price is up from about $40 to $160 over 18 months.
AI Corner:
See an AI Summary of the press release:
In the prospective, multicenter DEFINE-HT study, Natera’s Prospera™ Heart test with Donor Quantity Score (DQS) demonstrated a strong correlation between elevated donor-derived cell-free DNA (dd-cfDNA) levels and adverse clinical outcomes in heart transplant patients. Outcomes included treated rejection, graft dysfunction, re-transplantation, and death at one year.
Among over 1,100 samples analyzed, patients with elevated dd-cfDNA had a 2.6-fold higher risk of adverse outcomes (p=0.0299), and dd-cfDNA levels were three times more predictive of graft dysfunction than endomyocardial biopsy (EMB). Prospera with DQS outperformed donor fraction alone and offers a noninvasive, SNP-based assay with potential to replace EMB in surveillance, pending results from the ongoing ACES-EMB trial.
