Natera Announces Completion of Enrollment in Randomized ACES-EMB Trial in Heart Transplantation

Key Terms

dd-cfDNA medical

Donor-derived cell-free DNA (dd-cfDNA) are tiny fragments of DNA from a transplanted organ that float in the blood of the recipient; testing measures how much of the free DNA comes from the donor. Like finding fresh crumbs that reveal whether something has been disturbed, higher levels can indicate organ injury or rejection before symptoms appear, so investors watch adoption of these noninvasive tests because they can change follow-up care, reduce costly biopsies, and drive demand for new diagnostics and monitoring services.

biopsy medical

A biopsy is a medical procedure that removes a small piece of tissue or cells so a doctor can examine them under a microscope to see if disease, such as cancer or an infection, is present. For investors, biopsy results can change the outlook for drugs, diagnostics and medical devices—think of it like sampling a bite of food to decide whether the whole dish is safe; positive or negative findings can affect clinical trial success, approval chances, market demand and reimbursement decisions.

ACES-EMB is the first randomized-controlled trial to compare dd-cfDNA surveillance to routine biopsy in organ transplantation, highlighting the benefits of Prospera™ in organ rejection

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the completion of enrollment in ACES-EMB, the first randomized-controlled trial evaluating whether Natera’s Prospera Heart test can replace routine invasive biopsies for rejection monitoring in heart transplant recipients.

Positive results would support a fundamental shift in the standard of care for heart transplant recipients away from invasive tissue sampling to non-invasive molecular monitoring for the approximately 4,500 heart transplants performed annually in the United States. Biopsy procedures are costly, error-prone and put patients at risk of related complications.

EMB is the current standard of care for post-transplant rejection surveillance but requires repeated invasive procedures. ACES-EMB is designed to assess whether molecular surveillance using a non-invasive donor-derived cell-free DNA (dd-cfDNA)-based approach with Natera’s Prospera test can provide comparable clinical outcomes, and potentially reduce reliance on routine biopsies.

ACES-EMB enrolled more than 300 patients across 17 U.S. transplant centers. Patients were randomized at one month after transplant to either surveillance with the Prospera test or standard EMB-based care, and they will be followed for 12 months.

“ACES-EMB is a novel clinical trial in heart transplantation that could support the replacement of invasive, risky and expensive biopsy procedures with a simple blood test,” said Palak Shah, M.D., M.S., Inova Schar Heart and Vascular, and principal investigator for ACES-EMB. “This trial could fundamentally change the way we care for our patients, demonstrating the potential of dd-cfDNA testing as the surveillance modality of choice after transplant.”

“Completion of enrollment in ACES-EMB marks an important milestone toward generating the level of evidence needed to inform changes in heart transplantation,” said Sangeeta Bhorade, M.D., chief medical officer of organ health at Natera. “By directly comparing dd-cfDNA surveillance to biopsy-based care in a randomized setting, we aim to show the clear benefits of non-invasive testing with Prospera.”

About Natera

Natera™ is a global leader in cell-free DNA and precision medicine, 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 supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. 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, our expectations of the reliability, accuracy, and performance of our tests, or 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.

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Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com

Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.