Alexander WisemanMD, Executive Director of Kidney Transplantation at Centura Transplant Christopher BlosserMD, Clinical Associate Professor at University of Washington & Seattle Children Hospital Naoka MurakamiMD, PhD, FASN, Instructor of Medicine, Harvard Medical School; Associate Physician, Renal Division, Brigham and Women's Hospital
Irfana SoomroMD, Assistant Professor at New York University Langone Medical Center J. Keith MelanconMD, FACS, Chief of Transplant Instituteand Division of Transplant Surgeryat George Washington University Tariq ShahMD, former Medical Director at St. Vincent Medical Center
"The Prospera test offers a novel approach for assessing the status of a patient's transplanted organ," said
T cell-mediated rejection (TCMR) is the most common type of rejection in the first year post transplant.1 When undetected and untreated, it can lead to lower glomerular filtration rates (GFR), de novo donor specific antibodies (DSA), and eventually antibody mediated rejection (ABMR) and graft loss. The Prospera test is the only dd-cfDNA test validated to identify both TCMR and ABMR.2,3
About the Prospera™ dd-cfDNA Organ Transplant 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. Prospera has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation.
The test was developed by
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the
- Halloran PF, Chang J, Famulski K, et al. Disappearance of T Cell-Mediated Rejection Despite Continued Antibody-Mediated Rejection in Late Kidney Transplant Recipients. J Am Soc Nephrol. 2015;26(7):1711–1720.
- Sigdel TK, Archila FA, Constantin T, et al. Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCR. J Clin Med. 2019;8(1):19. pii: E19.
- Bloom RD, Bromberg JS, Poggio ED, et al. Cell-free DNA and active rejection in kidney allografts. J Am Soc Nephrol. 2017;28(7):2221-2232.
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