Major Clinical Study Supports NIPT As First Line Screening Test For All Pregnant Women
Analysis of over 17,000 cases finds that clinical performance of PanoramaTM NIPT is consistent in high and low risk populations
Natera, Inc., a leader in non-invasive genetic testing, today announced a study to be published in the November issue of American Journal of Obstetrics and Gynecology, which shows that Panorama™ NIPT performs consistently well in all pregnant women, regardless of their prior risk level. This is the largest ever published study of clinical outcomes with NIPT, following more than 17,000 consecutive cases originally analyzed by Natera in mid-2013. It is also the second in a series of published studies showing strong test performance in low risk populations.
“This study supports the use of NIPT as a first line screening test for aneuploidy,” said lead author Peer Dar, MD, Head of Fetal Medicine at Montefiore Medical Center in New York. “These results are consistent with recent NIPT guidelines published by the American College of Medical Genetics and Genomics (ACMG) that do not distinguish between high risk and low risk pregnancies, and which recommend NIPT in conjunction with first trimester ultrasound.”
Key findings of this study:
- Performance of the Panorama NIPT, determined previously in published case-controlled validation studies, has now been confirmed in a clinical setting with this study, the largest clinical outcomes study of NIPT to date.
- NIPT is already being adopted by some low-risk women and their healthcare providers, with 49% of the cases in this clinical study from women under 35 years of age.
- The authors find that there are no concerns about performance of NIPT as a first line screen, and it will be accessibility and affordability that determine universal adoption.
- The study highlighted an important performance metric: positive predictive value (PPV). Panorama’s demonstrated PPV is significantly higher than traditional serum screening, by an order of magnitude. This should translate to a significant reduction in unnecessary invasive procedures and enhanced patient safety.
The results of this study, entitled “Clinical experience and follow-up with large scale single-nucleotide polymorphism-based non-invasive prenatal aneuploidy testing,” by lead author Dr. Peer Dar and senior author, Dr. Peter Benn, are available online at www.ajog.org.
Natera is a genetic testing company that designs targeted assays to analyze tiny quantities of DNA. The mission of the company is to help families diagnose and manage genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif., currently offering a host of preconception and prenatal genetic testing services primarily to OBGYN physicians and in-vitro fertilization centers. In 2013, the company launched Panorama™, a safe, simple test for pregnant women that screens for the most common chromosomal anomalies in a fetus as early as nine weeks of gestation. Tests developed by Natera have not been cleared or approved by the U.S. Food and Drug Administration (FDA). For more information, visit www.natera.com.
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Mike Hromadik, 858-442-2215