Natera Announces Publication Highlighting Importance of Testing Total cfDNA when Monitoring Kidney Transplant Patients with COVID-19 Infection

Rhea-AI Summary

Natera, Inc. (NASDAQ: NTRA) announced a study published in Transplantation Proceedings that highlights the significance of total cell-free DNA (cfDNA) testing in kidney transplant recipients hospitalized with COVID-19. Using its Prospera™ test, the study reveals that elevated total cfDNA can obscure donor-derived cfDNA (dd-cfDNA) levels, potentially masking transplant rejection cases. The Prospera test identified two patients whose biopsy-proven rejections were undetected by dd-cfDNA alone. This research underscores the necessity of total cfDNA in understanding graft health amidst COVID-19 challenges.

Positive

• The study demonstrates Prospera™ test's critical role in detecting kidney transplant rejection despite COVID-19 complications.
• The Prospera test identified undetected rejections in patients using total cfDNA analysis.

Negative

• None.

AUSTIN, Texas, April 1, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, announced the results of a study¹ to examine both total and donor-derived cell-free DNA (dd-cfDNA) in kidney transplant recipients hospitalized with COVID-19 using its Prospera™ test to assess disease severity and risk of rejection.

The study, published in Transplantation Proceedings, used the Prospera test to examine the relationship between total cfDNA and dd-cfDNA fraction when monitoring for rejection. The results indicate that high levels of total cfDNA, as can occur due to COVID-19 infection, result in a lower dd-cfDNA donor fraction and could inadvertently mask rejection when using donor fraction alone. The Prospera test identified two patients in the cohort with elevated total cfDNA and biopsy-proven rejection that would have otherwise gone undetected by dd-cfDNA donor fraction alone.

"COVID-19 has presented unique challenges in monitoring and treating kidney transplant recipients and it's clear that infection is one of the many factors that can impact cfDNA levels - and therefore a dd-cfDNA fraction," said José Otto Reusing Jr., principal investigator and lead author of the study, at the University of São Paulo School of Medicine in Brazil. "The ability to test total cfDNA with Prospera is critical to establishing a more complete and thorough understanding of graft health with these patients."

Natera incorporated total cfDNA into the Prospera test in 2021, based on previous studies^2-4 that showed combining analysis of dd-cfDNA and total cfDNA improved performance when evaluating transplant rejection.

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,) and the total 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 enable earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 100 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 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 or other 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 SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 pr@natera.com

References

1. Reusing Jr JO, Yoo J, Desai A, et al. Association between total cell free DNA and SARS-CoV-2 in Kidney Transplant Patients: A Preliminary Study. Transplant. Proc. 2022. ISSN 0041-1345.
2. Halloran, et al. Manuscript in preparation, anticipated publication in 2022.
3. Bunnapradist S, Homkrailas P, Ahmed E, Fehringer G, Billings PR, Tabriziani H. Using both Fraction and Quantity of Donor-Derived Cell-Free DNA to Detect Kidney Allograft Rejection. J Am Soc Nephrol. 2021;32(10):2439-2441.
4. Bunnapradist S, Datta N, Schaenman J, et al. Extremely High Cell-free DNA Levels Observed in Renal Allograft Patient With SARS-CoV-2 Infection. Transplant Direct. 2021;7(5):e691.

 

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SOURCE Natera, Inc.

FAQ

What is the significance of Natera's recent study on COVID-19 and kidney transplants?

Natera's study emphasizes the importance of total cell-free DNA testing in accurately monitoring kidney transplant rejection in patients with COVID-19.

How does the Prospera test improve kidney transplant monitoring according to Natera?

The Prospera test combines total cfDNA and donor-derived cfDNA analysis, enhancing the ability to detect graft rejection in kidney transplant patients.

When was the study regarding total cfDNA testing in kidney transplants published?

The study was published on April 1, 2022, in the journal Transplantation Proceedings.

What are the implications of high total cfDNA levels for kidney transplants?

High total cfDNA levels can obscure donor-derived cfDNA readings, potentially masking cases of rejection which could lead to serious health risks.

What institution was involved in Natera's study on the Prospera test?

The study was conducted by researchers at the University of São Paulo School of Medicine in Brazil.