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Recent Publication Supports the Cost Effectiveness of NIPT for All Pregnant Women, Regardless of Prior Risk
Date:8/10/2015

SAN CARLOS, Calif., Aug. 10, 2015 /PRNewswire/ -- Natera, Inc., (Nasdaq: NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, today announced new data that supports the use of non-invasive prenatal testing (NIPT) as a first line screening for chromosomal aneuploidies and related conditions.

Peter Benn, DSc., Professor of Genetics at the UCONN Health Center, initiated a comprehensive economic analysis of NIPT and alternative methods, one of the first studies to incorporate U.S. based clinical and cost models in a general patient population. Dr. Benn concluded, "Universal application of NIPT would increase fetal aneuploidy detection rates and can be economically justified. Replacing conventional screening with NIPT would reduce healthcare costs if it can be provided for $744 or less in the general patient population."  Dr. Benn's study, An Economic Analysis of Cell-Free DNA Non Invasive Prenatal Testing in the US General Pregnancy Population will be published in the August issue of PLOS ONE.

Two additional recently released peer-reviewed articles support Dr. Benn's conclusion that NIPT can be a cost effective screening option for all women, regardless of age or risk.

  • Walker, et al. found "Universal NIPT remained less costly than conventional MSS [maternal serum screening] so long as the cost of NIPT was below $619," in A Cost-Effectiveness Analysis of First Trimester Non-Invasive Prenatal Screening for Fetal Trisomies in the United States.2
  • Fairbrother et al., reported: "As NIPT identifies more fetal trisomies than FTS [first trimester screen], a NIPT unit cost of $665 allows a cost per trisomy case identified to be equivalent to that of FTS," in Prenatal Screening for Fetal Aneuploidies with Cell-free DNA in the General Pregnancy Population: A Cost-effectiveness Analysis.3

This data complements the September, 2015 American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal Fetal Medicine (SMFM) Committee Opinion, Cell-free DNA Screening for Fetal Aneuploidy: "Any patient may choose cell-free DNA analysis, regardless of their risk status… The patient should understand the limitations and benefits of this screening paradigm in the context of alternative screening and diagnostic options."

"The body of clinical and economic data supporting NIPT is significant," said Steve Chapman, Senior Vice President and head of Natera's health policy initiatives.  "We applaud our leading society's opinion allowing women to choose cell-free DNA analysis, regardless of their risk status."

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 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. 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.

Contacts
GOLD PR for Natera
Jill Edgeworth, 847-778-1538
jedgeworth@goldpr.com

Natera, Inc.
Michael Hromadik, 858-442-2215
mhromadik@natera.com

1 Benn P, Curnow KJ, Chapman S, et al. (2015) An Economic Analysis of Cell-Free DNA Non-Invasive Prenatal Testing in the US General Pregnancy Population. PLoS ONE 10(7): e0132313. doi:10.1371/journal.pone.0132313

2 Walker BS, Nelson RE, Jackson BR, et al. (2015) A Cost-Effectiveness Analysis of First Trimester Non-Invasive Prenatal Screening for Fetal Trisomies in the United States. PLoS ONE 10(7): e0131402. doi:10.1371/journal.pone.0131402

3 Fairbrother G, Burigo J, Sharon T, et al. (2015) Prenatal screening for fetal aneuploidies with cell-free DNA in the general pregnancy population: a cost-effectiveness analysis. Journal of Maternal-Fetal & Neonatal Medicine.

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