Natera Announces Results From DNAFirst Study, Validating Use Of NIPT In Routine Prenatal Care
Results demonstrate clinical utility of NIPT as first line screen in a general population
Study results published in Genetics in Medicine
SAN CARLOS, Calif., Jan. 17, 2017 /PRNewswire/ -- Natera, Inc., (NASDAQ: NTRA), a leader in non-invasive genetic testing, today announced the results from the DNAFirst trial, showing that non-invasive prenatal screening tests (NIPT) can be effectively and appropriately offered as a primary screen for all pregnant women, regardless of risk due to maternal age or other factors. This is the first report of a routine clinical use of cfDNA-based prenatal screening for common aneuploidies in a general U.S. population, offered through primary obstetric care providers. The results of this study were published on January 12, 2017 online in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics.
The DNAFirst study, led by Glenn E. Palomaki, Ph.D., of Brown University and Women and Infant's Hospital in Rhode Island, involved 2,681 women who were screened with Panorama® through 72 healthcare providers in Rhode Island. Pre-test counseling was provided solely by the women's primary obstetrical care provider, including women's physicians, nurse midwives and nurse/educators. The median patient age was 31 years, with approximately 79 percent of participating women less than 35 years of age. In the study, Panorama's performance in this general risk population was consistent with previously published clinical validation and experience data with excellent sensitivity (12/12) with no false negatives in the cohort, 75 percent positive predictive value (PPV) across all conditions and 0.15 percent combined false positive rate (FPR). Screening reports were issued to 99.85% of women in the study who were tested, after retesting as needed by either NIPT or serum screening.
In a survey conducted following the study, women reported sufficient time to talk with their provider (95%), having their questions answered (96%) and felt the optional nature of screening was conveyed (99%). The majority of women correctly recalled that the NIPT was not diagnostic and evaluated risk for a limited number of conditions. Approximately 93 percent of women rated their decision to consent to the screening as 'good' or 'great' and nearly all would recommend NIPT to a friend (98 percent) or undergo the test in their next pregnancy (95 percent).
Providers were given a short (10-20 minute) in-service education at a convenient location, questions were answered and patient education / test requisitions provided. Following completion of the study, 83 percent of providers surveyed believed they and their staff were adequately prepared to implement NIPT in their practice, without the need for additional, more extensive education.
"The results of this study demonstrate that NIPT can be utilized as a first line screen for aneuploidy in the general obstetrical population with pre-test counseling by primary obstetrical care providers. This publication describes a straightforward, efficient and effective protocol for provider and patient education that should allay concerns about the ability of healthcare providers to offer this testing in the context of routine obstetrical care," said Kimberly Martin, MD, Senior Global Medical Director, Women's Health at Natera. "The level of patient understanding achieved in this study is comparable to that observed following formal genetic counseling for NIPT and among women who've undergone traditional serum screening, based on recent studies. These data support recent medical societies' recommendations that NIPT should be offered to all women, regardless of risk category."
About Natera 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 test to detect inherited mutations; and the Panorama® non-invasive prenatal test to detect 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.
Forward-looking statements 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 with respect to whether the results of clinical studies will support the use of our tests, our ability to enroll sufficient numbers of patients in studies, our ability to increase demand for our screening tests, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests to patients, providers and payers.
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 September 30, 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 SEC's website at www.sec.gov.