Natera Announces Publication Highlighting the Importance of Testing Total cfDNA When Monitoring COVID-19 Infected Kidney Transplant Patients

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AUSTIN, TX, 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 .

(PRNewsfoto/Natera, Inc.)

the studyPosted in Transplant procedure, used the Prospera assay to examine the relationship between total cfDNA and dd-cfDNA fraction when monitoring rejection. The results indicate that high levels of total cfDNA, as may occur due to COVID-19 infection, results in a lower dd-cfDNA donor fraction and could inadvertently mask rejection when using the donor fraction alone. The Prospera assay identified two patients in the cohort with elevated total cfDNA and biopsy-proven rejection that otherwise would not have been detected by the dd-cfDNA donor fraction alone.

“COVID-19 has presented unique challenges in the monitoring and treatment of kidney transplant recipients and it is clear that infection is one of many factors that can impact cfDNA levels – and therefore a dd-cfDNA fraction,” said José Otto Reusing Jr.principal researcher and lead author of the study, at the University of São Paul’s school of medicine in Brazil. “The ability to test total cfDNA with Prospera is critical to establishing a more complete and in-depth understanding of graft health in these patients.”

Natera incorporated total cfDNA into the Prospera test in 2021, based on previous studies2-4 who showed that the combination of dd-cfDNA and total cfDNA analysis improved performance when assessing transplant rejection.

About the Prospera test

the will prosper leverages Natera’s 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 genotyping of the donor or the recipient. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) and total cfDNA in the recipient’s blood. It can be used by physicians considering the diagnosis of active rejection, helping to rule out or rule out this condition when evaluating the need for a diagnostic test or the results of an invasive biopsy. The Prospera test has been clinically and analytically validated for performance regardless of donor relationship, type of rejection and clinical presentation. It was 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 United States 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. Our goal is to integrate personalized genetic testing and diagnostics into the standard of care to protect health and enable earlier, more targeted interventions that help lead longer, healthier lives. Natera’s tests are validated by over 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485 certified and CAP accredited laboratories under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, TX 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 do not constitute 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 any 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 market new product offerings, our ability to successfully increase demand and increase revenue from our product. offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations regarding the reliability, accuracy, and performance of our screening tests, or the benefits of our screening tests and offerings products for patients, providers and payers . Additional risks and uncertainties are discussed in more detail in the “Risk Factors” section of Natera’s recent filings on Forms 10-K and 10-Q and in other filings by Natera with the SEC from time to time. other. These documents are available at www.natera.com/investors and www.sec.gov.

contacts

Investor Relations: Mike BrophyChief Financial Officer, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 [email protected]

The references

  1. Reuse of 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, publication expected in 2022.

  3. Bunnapradist S, Homkrailas P, Ahmed E, Fehringer G, Billings PR, Tabriziani H. Using both donor-derived cell-free DNA fraction and amount to detect renal 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 seen in a renal allograft patient with SARS-CoV-2 infection. Direct transplant. 2021;7(5):e691.

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