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


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NateraInc. (NASDAQ: NTRA), a world 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 transplant recipients kidneys hospitalized with COVID-19. 19 using its Prospera™ test to assess disease severity and risk of rejection.

the studyPosted in Transplant procedure, used the Prospera assay to examine the relationship between total cfDNA and dd-cfDNA fraction during rejection monitoring. 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., lead researcher 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 in-depth understanding of graft health in these patients.”

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

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.


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