Natera Supports Updated ISHLT Guidelines for the Care of Heart Transplant Patients

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, announced its support for a recent guideline update by the International Society for Heart and Lung Transplantation (ISHLT), which includes the use of donor-derived cfDNA (dd-cfDNA) testing for surveillance of heart transplant recipients. The updated ISHLT guidelines, which were last revised in 2010, were published today in the Journal of Heart and Lung Transplantation¹.

In the newly updated guidelines, ISHLT includes dd-cfDNA testing in a Class I, Level B recommendation covering the suggested components for ongoing rejection monitoring in heart transplant recipients. The recommendation proposes monitoring for rejection (with noninvasive biomarkers or biopsy) monthly during the first six months post transplant, as well as testing in the 9th and 12th months post transplant.

“We commend ISHLT on these recently updated guidelines that will undoubtedly help improve and standardize care management for heart transplant recipients,” said Dr. Sangeeta Bhorade, chief medical officer for organ health at Natera. “This important change is a testament to the data supporting dd-cfDNA testing for heart transplant patients, and we remain committed to generating robust scientific evidence to improve care for transplant patients.”

Natera launched the Prospera Heart dd-cfDNA test in late 2021. The clinical validation study of 811 samples from 223 patients from the multi-site DEDUCE study was published in 2022 in the Journal of Heart and Lung Transplantation². The Prospera Heart test was also evaluated in the NIH-supported DTRT study (publication to be submitted early 2023).

About the Prospera test

The Prospera 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. It has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.