SAN CARLOS, Calif., Aug. 1, 2016 /PRNewswire/ — Natera, Inc., (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, announced a research collaboration with the University of California, San Francisco (UCSF), a leader in renal transplantation medicine in North America, to study the level of donor-derived cell-free DNA (dd-cfDNA) in over several hundred retrospectively banked plasma samples from kidney transplant recipients with and without organ injury.
There is a significant unmet need for a more accurate non-invasive diagnostic test for renal transplant care. Currently, physicians rely on a combination of creatinine measures and invasive needle biopsies, which often result in inconclusive results or a diagnosis of acute rejection after the damage to the kidney is irreversible.
Multiple studies have shown dd-cfDNA has a potential to be a universal marker for acute rejection for solid organs. Under this research collaboration, Natera will analyze the dd-cfDNA level of plasma samples collected at UCSF from kidney transplant patients using Natera’s proprietary massively-multiplexed PCR (mmPCR) platform and proprietary statistical algorithms. Through this research collaboration, Natera and UCSF will investigate whether the routine measurement of dd-cfDNA can help predict organ injury and ultimately improve clinical outcomes.
"We are honored to be working with Professor Minnie Sarwal, an internationally recognized leader in the fields of renal and transplant medicine," said Matthew Rabinowitz, Ph.D., CEO of Natera. "Collaborations of this kind advance the needs of patients, and are very efficient vehicles to further expand the range of clinically actionable applications for our technology platform."
"The advances we’ve made in organ transplant over the past few decades have made a tremendous difference in our patients’ quality of life, but it is still very difficult to detect quickly whether an individual patient is recovering well or rejecting the organ," said Sarwal, MD, Ph.D., a UCSF professor of medicine and nephrologist at UCSF Health. "Because the speed of that detection is crucial in preventing acute rejection, our goal is to develop a test that will help us identify which patients are at greatest risk, before the damage is irreversible."
Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software system. Tests include the Spectrum® pre-implantation genetic test for embryo selection during IVF; the Anora® miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier screen to detect inherited mutations; and the Panorama® non-invasive prenatal test (NIPT) to screen for common chromosomal anomalies in a fetus as early as nine weeks of gestation. Each test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. These tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.
Natera is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not been cleared or approved by the U.S. Food and Drug Administration.
This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release. These forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results to differ materially, including uncertainty in the development and commercialization of Natera’s planned future cancer products or other new products or if the results of its clinical studies do not support the use of its tests, or cannot be replicated in later studies required for regulatory approvals or clearances. Additional risks and uncertainties are discussed in greater detail in the sections entitled "Risk Factors" and "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in Natera’s Form 10-Q for the quarter ended March 31, 2016. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. These documents are available for free on the company’s website at www.natera.com under the Investor Relations section, and on the SEC’s website at www.sec.gov.
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This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved.
Mike Brophy, Investor Relations, 650 249 9091 x 1471
Laura Zobkiw, 650 249 9091 x 1649
SOURCE Natera, Inc.