Natera Presents Latest in Transplant Innovation Data Across Multiple Organs at ATC 2024

Rhea-AI Summary

Natera (NASDAQ: NTRA) will present new data on its Prospera donor-derived cell-free DNA (dd-cfDNA) test at the American Transplant Congress (ATC) 2024 from June 1–5. The company will showcase 18 abstracts, including results from the ProActive study, the largest prospective dd-cfDNA study in kidney transplant recipients. Key findings highlight the Prospera Kidney test's efficacy in predicting organ rejection, with results demonstrating a high predictive value (AUC range: 92-96%). Additional data show significant variation in dd-cfDNA levels, suggesting its utility in ongoing surveillance and risk stratification for adverse outcomes.

Positive

• Natera to present 18 abstracts at ATC 2024, showcasing the breadth of clinical evidence supporting Prospera across multiple organ types.
• ProActive study results show the Prospera Kidney test has a high predictive value for allograft rejection (AUC range: 92-96%).
• Data from 866 kidney transplant patients show dd-cfDNA variation can indicate clinical significance, aiding in result interpretation and patient monitoring.
• Findings from 370 kidney transplant patients suggest dd-cfDNA trends help stratify patients into different risk categories.
• Elevated dd-cfDNA at non-rejection biopsy correlates with future allograft rejection, emphasizing the need for close monitoring.

Negative

• No specific financial or business development data was provided in the press release, leaving investors without insight into potential revenue impacts or commercialization plans.
• The focus on clinical data without accompanying financial metrics might limit investor's ability to assess the immediate economic benefits of these findings.
• Although the Prospera test shows high predictive value, the press release does not address how these findings will translate into market adoption or reimbursement.

Insights

Medical Research Analyst

The data presented at the American Transplant Congress (ATC) 2024 indicates that Natera's Prospera Kidney test continues to show high accuracy in predicting allograft rejection across multiple organ types. The ProActive study's results, particularly with its large sample size of 1,022 kidney transplant patients, showcase an area under the curve (AUC) range of 92-96%, highlighting the test's exceptional predictive capabilities. This is significant as the AUC is a measure of the test's ability to distinguish between patients with and without the condition— in this case, transplant rejection. High AUC values indicate a high level of accuracy.

Market Research Analyst

The continuous stream of positive data from the ProActive study reinforces the market potential for Natera’s Prospera Kidney test. The study's large cohort and statistically significant results in detecting variations in donor-derived cell-free DNA (dd-cfDNA) provide strong validation. Investors should note that the clinical acceptance and usage of such tests are likely to increase, boosting revenue. However, the broad applicability across heart, lung, kidney and multi-organ transplants opens up multiple revenue streams, enhancing long-term growth prospects. The precision of the test, especially with longitudinal tracking, sets a new standard in transplant surveillance, encouraging wider adoption.

Financial Analyst

From a financial standpoint, Natera's presentation of new clinical data at a prestigious conference like ATC adds considerable weight to its product portfolio. The robust performance metrics of the Prospera Kidney test can drive market confidence and potentially lead to increased sales and adoption rates. More importantly, the high predictive accuracy (92-96% AUC) and the stratification of patients based on dd-cfDNA trends suggest a compelling value proposition for healthcare providers. This differentiation can translate into a competitive advantage, driving revenue growth. However, investors should consider the competitive landscape and potential reimbursement issues that might impact long-term profitability. Overall, the data supports a positive outlook but necessitates cautious optimism.

Includes new results from the ProActive study, reinforcing the utility of the Prospera™ Kidney test for ongoing surveillance of transplant rejection

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced that the company will present new data on its Prospera donor-derived cfDNA (dd-cfDNA) test at the American Transplant Congress (ATC) 2024 taking place June 1–5, 2024.

Natera and its collaborators will present 18 abstracts highlighting new Prospera data across heart, lung, kidney, and multi-organ transplantation. This includes an oral presentation highlighting the predictive capabilities of the Prospera Kidney test from the ProActive study, the largest prospective dd-cfDNA study in kidney transplant recipients.

“We look forward to sharing new research at ATC that demonstrates the breadth of clinical evidence supporting Prospera across multiple organ types,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera. “This includes new data from the landmark ProActive study, reinforcing the value of the Prospera Kidney test as a highly accurate surveillance tool for detecting ongoing organ rejection and predicting future rejection.”

Highlights from selected abstracts include:

• Oral Presentation | Abstract # 362 | Presenter: Elliot Aguilar, PhD | June 2, 3:00 PM - 4:00 PM ET | Prospera Kidney
  Exploring Total and Donor Cell-Free DNA in Kidney Transplants: A Differential Rejection Analysis of Antibody Mediated and T-Cell Mediated Rejections
  
  Results from 1,022 kidney transplant patients enrolled in the ProActive study showed excellent performance of the Prospera Kidney test for predicting allograft rejection when combining clinical factors and key biomarkers with longitudinal testing, improving performance further (area under the curve range: 92-96%).

• Poster Presentation | Abstract # A172 | Presenter: Milagros Samaniego-Picota, MD | June 1, 5:30 - 7:00 PM ET | Prospera Kidney
  Clinically Significant Variation of dd-cfDNA in Kidney Transplant Recipients
  
  Results from 866 stable kidney transplant patients enrolled in the ProActive study show that a change of dd-cfDNA fraction of more than 72.9% between sequential results may indicate clinical significance and be especially useful for the interpretation of borderline results. Additionally, longitudinal variance within an individual supports the need for surveillance to establish baseline values.

• Poster Presentation | Abstract # C215 | Presenter: Suphamai Bunnapradist, MD, MS | June 3, 9:15 - 10:00 AM ET & 2:30 - 3:15 PM ET | Prospera Kidney
  Longitudinal dd-cfDNA trends and clinical outcomes in kidney transplant recipients
  
  Findings from 370 kidney transplant patients enrolled in the ProActive study suggest that dd-cfDNA trends may allow for the stratification of patients into different risk categories. Notably, dd-cfDNA levels consistently below 0.3% were associated with a low incidence of adverse outcomes. The likelihood of adverse events increased with additional elevations in dd-cfDNA.

• Poster Presentation | Abstract # A178 | Presenter: Hossein Tabriziani, MD, PhD | June 1, 5:30 - 7:00 PM ET | Prospera Kidney
  Is dd-cfDNA Prognostic for Future Kidney Allograft Rejection?
  
  In 452 kidney transplant patients, elevated dd-cfDNA at the time of a non-rejection biopsy was significantly associated with future allograft rejection, suggesting that patients with elevated dd-cfDNA should be considered at high risk for future rejection and monitored closely.

Additionally, Natera will host a lunch symposium on June 2nd from 12:15 - 1:15 PM ET titled, “Monitoring matters: Latest data supporting Prospera™ dd-cfdna for routine kidney transplant care.” It will include participation from Zahraa Hajjiri, MD, assistant professor of medicine, interim UNOS medical director, Transplant Nephrology, AST Transplant Nephrology Fellowship Director, University of Illinois-Chicago, Anil Chandraker, MD, professor of medicine, UMass Chan School of Medicine, chief, division of Renal Medicine, UMass Memorial Health Care, and Ali Zarrinpar, MD, PhD, professor, University of Florida College of Medicine, University of Florida Health.

The data being presented at ATC adds to the growing body of research supporting Natera’s organ health tests, which includes over 40 peer-reviewed publications.

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.

About Natera

Natera^TM is a global leader in cell-free DNA testing and genetic 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 200 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240530845740/en/

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com

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

Source: Natera, Inc.

FAQ

What is the significance of Natera's presentation at ATC 2024?

Natera will present 18 abstracts highlighting new data on the Prospera test, showcasing its efficacy in predicting organ rejection across multiple organ types.

When is Natera presenting its latest transplant innovation data?

Natera will present its data at the American Transplant Congress (ATC) 2024, taking place from June 1–5, 2024.

What is the ProActive study mentioned in the Natera press release?

The ProActive study is the largest prospective study on donor-derived cell-free DNA (dd-cfDNA) in kidney transplant recipients, providing key data on the Prospera test's predictive capabilities.

What were the key findings from the ProActive study presented by Natera?

The ProActive study showed the Prospera Kidney test's high predictive value for allograft rejection with an AUC range of 92-96%, and highlighted the clinical significance of dd-cfDNA variations.

How does the Prospera Kidney test benefit kidney transplant patients?

The Prospera Kidney test benefits patients by providing accurate surveillance for ongoing organ rejection and predicting future rejection, aiding in patient monitoring and risk stratification.