Natera Announces New Data From Two Studies Extending the Clinical Validation of Its Prospera Heart dd-cfDNA Test for Heart Transplant Recipients - Seite 2

The Trifecta-Heart study had its initial publication last week in Transplantation and has an upcoming oral presentation at the 2024 International Society for Heart and Lung Transplantation (ISHLT) Annual Meeting. This initial readout included 137 plasma samples analyzed using the Prospera Heart test, correlated with matched EMBs analyzed using the Molecular Microscope Diagnostic System (MMDx), a more objective reference standard for rejection compared to histopathology. Based on data collected in the first 18 months, the Prospera Heart test was highly accurate in distinguishing acute rejection from non-rejection, with an AUC of 0.90 and a NPV of 96%. These results affirm the strong performance of Prospera Heart shown in the DEDUCE study.

Roughly 4,100 heart transplants are performed each year in the U.S., including about 490 pediatric recipients in 2022.¹ Biopsies, which are the current standard of care for heart transplant surveillance, have a complication rate ranging between 1-5%.^2-6 Further, due to modern immunosuppression regimens, acute rejection rates, as detected by surveillance biopsies, are now lower than the rate of biopsy complications.⁷ This highlights the imbalance in risk versus reward and argues in favor of a non-invasive alternative to monitor for rejection.

These latest data come just before the 2024 ISHLT Annual Meeting, where Natera will deliver one oral presentation and six poster presentations related to its Prospera Heart and Prospera Lung tests.

About the Prospera test

The Prospera^TM test leverages Natera’s core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient’s blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation.