Natera Announces Publication of Largest Prospective dd-cfDNA Study in Kidney Transplantation

ProActive study shows Natera’s Prospera Kidney™ test detects rejection five months before biopsy

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced a new publication from the ProActive study in Transplantation supporting the use of the Prospera Kidney donor-derived cfDNA (dd-cfDNA) test as a leading indicator of kidney transplant rejection. The published manuscript can be found here.

The ProActive study is the largest prospective dd-cfDNA study in kidney transplant recipients, with roughly 5,000 patients enrolled at 54 participating transplant centers. This published study included 1,631 patients with ≥18 months of follow-up data. Key findings include:

• dd-cfDNA levels were significantly elevated up to five months before biopsy-proven antibody-mediated acute rejection (ABMR) and up to two months before biopsy-proven T cell-mediated rejection (TCMR) compared to patients with a non-rejection biopsy. In contrast, serum creatinine levels were not significantly elevated at any time point before biopsy-proven TCMR or ABMR.
• Multiple increased dd-cfDNA results were associated with lower eGFR, high immunological risk factors, and suspected ABMR in the absence of rejection on biopsy. These data further support the Prospera Kidney test’s value as an early indicator of rejection vs biopsy.
• Real-world performance of the Prospera Kidney test to detect all forms of rejection in 249 patients with matched biopsy demonstrated an area under the curve of 0.88, showcasing performance consistent with prior validations.^1-4

“The ProActive study reinforces the utility of dd-cfDNA for monitoring kidney transplant patients and identifying those most at risk for rejection early on,” said Jonathan Bromberg, MD, professor of surgery and microbiology and immunology, vice chair for research at the University of Maryland School of Medicine, and principal investigator of the ProActive study. “By detecting elevations in dd-cfDNA before biopsy-proven rejection, we can open up a critical window of time when more effective treatments can be used to improve the chances of graft survival.”

“Current transplant surveillance tools are often lagging or inaccurate, and have several known limitations,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera. “We believe the ProActive study provides robust evidence in support of regular surveillance with the Prospera dd-cfDNA test, which the industry has long been awaiting. Natera remains excited to continue pursuing additional clinical evidence and optimizing the management of kidney transplant patients for improved long-term outcomes.”

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.

About Natera

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 180 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

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 whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, or our expectations of the benefits of our 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 SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

References

1. 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. 2018;8(1):19.
2. Halloran PF, Reeve J, Madill-Thomsen KS, et al. Combining Donor-derived Cell-free DNA Fraction and Quantity to Detect Kidney Transplant Rejection Using Molecular Diagnoses and Histology as Confirmation. Transplantation. 2022;106(12): 2435-2442.
3. Bunnapradist S, Homkrailas P, Ahmed E, Fehringer G, Billings P, Tabriziani H. Using both the Fraction and Quantity of Donor-Derived Cell-Free DNA to Detect Kidney Allograft Rejection. J. Am. Soc. Nephrol. 2021;32(10), 2439-2441.
4. Bromberg J, Bunnapradist S, Samaniego-Picota Milagros, et al. Elevation of Donor-derived Cell-free DNA Before Biopsy-proven Rejection in Kidney Transplant. Transplantation. 2024.

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