June 4, 2021
Natera Announces New Prospera™ Data at the ATC 2021 Virtual Connect Conference

AUSTIN, Texas, June 4, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA (cfDNA) testing, today announced it will present new data on its latest scientific innovations in cfDNA testing at the American Transplant Congress' (ATC) 2021 Virtual Connect, taking place June 4-9, 2021.

Three posters showcasing the scientific progress and performance of the Prospera test will be presented along with four sponsored presentations featuring leading transplant physicians. 

"We look forward to sharing our latest findings with the transplant community and believe these innovations will play an important role in helping nephrologists make more timely and informed decisions about the health of their patients' transplanted organs," said Bernie Tobin, Natera's general manager of organ health.

Details about Natera's symposia are as follows:

Fresh Perspectives on Rejection Assessment with cfDNA | June 5, 1:30 PM ET

New Methods to Evaluate Rejection Using Donor Fraction & Dd-cfDNA Quantity

  • Suphamai Bunnapradist, M.D., M.S., transplant nephrologist and professor of medicine, University of California, Los Angeles

Cell-free DNA Performance in Simultaneous Pancreas-Kidney and Pancreas Recipients

  • Samy Riad, M.D., M.S., assistant professor of medicine, division of nephrology and hypertension, University of Minnesota

Prospera in Action: Kinetics and Routine Surveillance

  • David Wojciechowski, D.O., medical director, kidney transplantation program, University of Texas Southwestern
  • Rodolfo Batarse, M.D., president & nephrologist, Desert Kidney Care
  • Ty Dunn, M.D., surgical director of kidney & pancreas transplantation, University of Pennsylvania

Prospera: The Power & Potential of cell-free DNA in Transplantation & Oncology | June 6, 11:30 AM ET

  • Hossein Tabriziani, M.D, FACP, FASN, medical director of organ transplantation at Natera, Inc.

Details about the abstract presentations are as follows:

Abstract #LB 76 | Poster Presentation | Presenter: Suphamai Bunnapradist, M.D., M.S.

Detection of rejection in kidney transplant patients using an algorithm that combines donor fraction and dd-cfDNA quantity

Results of a study incorporating the dd-cfDNA fraction with the dd-cfDNA quantity shows improved performance of the Prospera test to assess active rejection. The application of these two values resulted in an increased sensitivity.

Abstract #LB 19 | Oral Presentation | Presenter: Philip F. Halloran, M.D.

Relationship between %dd-cfDNA, MMDx molecular diagnoses, and donor-specific antibody in the Trifecta study

Investigating the relationship between dd-cfDNA, donor-specific antibody (DSA) status, and molecular characteristics of 176 kidney biopsies, as part of the Trifecta study. It finds that dd-cfDNA levels at the time of indication biopsy are highly correlated with class II DSA and rejection status. In addition, this talk will show that many cases of antibody-mediated rejection are DSA negative but still release high levels of dd-cfDNA.

Abstract #322 | Oral Presentation | Presenter: Philip F. Halloran, M.D.

The Trifecta study: Calibrating circulating donor-derived cell-free DNA at the time of indication biopsies against the molecular phenotype of the biopsy reveals a prominent association with NK cell genes

This Trifecta study analysis looks at 300 kidney biopsy samples from 14 centers using MMDx and Prospera test technologies. Genome-wide gene expression profiling indicates that natural killer cell genes, interferon gamma-induced genes and the molecular classifications of active rejection are strongly correlated with dd-cfDNA levels at the time of indication biopsy.

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) 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 pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

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 

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/natera-announces-new-prospera-data-at-the-atc-2021-virtual-connect-conference-301305899.html

SOURCE Natera, Inc.

AUSTIN, Texas, June 4, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA (cfDNA) testing, today announced it will present new data on its latest scientific innovations in cfDNA testing at the American Transplant Congress' (ATC) 2021 Virtual Connect, taking place June 4-9, 2021.

Three posters showcasing the scientific progress and performance of the Prospera test will be presented along with four sponsored presentations featuring leading transplant physicians. 

"We look forward to sharing our latest findings with the transplant community and believe these innovations will play an important role in helping nephrologists make more timely and informed decisions about the health of their patients' transplanted organs," said Bernie Tobin, Natera's general manager of organ health.

Details about Natera's symposia are as follows:

Fresh Perspectives on Rejection Assessment with cfDNA | June 5, 1:30 PM ET

New Methods to Evaluate Rejection Using Donor Fraction & Dd-cfDNA Quantity

  • Suphamai Bunnapradist, M.D., M.S., transplant nephrologist and professor of medicine, University of California, Los Angeles

Cell-free DNA Performance in Simultaneous Pancreas-Kidney and Pancreas Recipients

  • Samy Riad, M.D., M.S., assistant professor of medicine, division of nephrology and hypertension, University of Minnesota

Prospera in Action: Kinetics and Routine Surveillance

  • David Wojciechowski, D.O., medical director, kidney transplantation program, University of Texas Southwestern
  • Rodolfo Batarse, M.D., president & nephrologist, Desert Kidney Care
  • Ty Dunn, M.D., surgical director of kidney & pancreas transplantation, University of Pennsylvania

Prospera: The Power & Potential of cell-free DNA in Transplantation & Oncology | June 6, 11:30 AM ET

  • Hossein Tabriziani, M.D, FACP, FASN, medical director of organ transplantation at Natera, Inc.

Details about the abstract presentations are as follows:

Abstract #LB 76 | Poster Presentation | Presenter: Suphamai Bunnapradist, M.D., M.S.

Detection of rejection in kidney transplant patients using an algorithm that combines donor fraction and dd-cfDNA quantity

Results of a study incorporating the dd-cfDNA fraction with the dd-cfDNA quantity shows improved performance of the Prospera test to assess active rejection. The application of these two values resulted in an increased sensitivity.

Abstract #LB 19 | Oral Presentation | Presenter: Philip F. Halloran, M.D.

Relationship between %dd-cfDNA, MMDx molecular diagnoses, and donor-specific antibody in the Trifecta study

Investigating the relationship between dd-cfDNA, donor-specific antibody (DSA) status, and molecular characteristics of 176 kidney biopsies, as part of the Trifecta study. It finds that dd-cfDNA levels at the time of indication biopsy are highly correlated with class II DSA and rejection status. In addition, this talk will show that many cases of antibody-mediated rejection are DSA negative but still release high levels of dd-cfDNA.

Abstract #322 | Oral Presentation | Presenter: Philip F. Halloran, M.D.

The Trifecta study: Calibrating circulating donor-derived cell-free DNA at the time of indication biopsies against the molecular phenotype of the biopsy reveals a prominent association with NK cell genes

This Trifecta study analysis looks at 300 kidney biopsy samples from 14 centers using MMDx and Prospera test technologies. Genome-wide gene expression profiling indicates that natural killer cell genes, interferon gamma-induced genes and the molecular classifications of active rejection are strongly correlated with dd-cfDNA levels at the time of indication biopsy.

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) 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 pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

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 

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/natera-announces-new-prospera-data-at-the-atc-2021-virtual-connect-conference-301305899.html

SOURCE Natera, Inc.