April 24, 2014
Natera, Inc., a leading innovator in prenatal genetic testing, today announced that it has received a new conditional approval from the New York State Department of Health to offer its Panorama™ non-invasive prenatal test (NIPT) for aneuploidies and 22q11.2 deletion syndrome in all pregnant women.
“This conditional approval marks another major milestone for Natera, and it reflects the strength of Natera’s validation methodology,” said Matthew Rabinowitz, Ph.D., chief executive officer of Natera. “We are encouraged by the rapid adoption of microdeletion screening since its release in March, and we are pleased that expecting parents in New York will now have access to the latest prenatal testing technology.”
The Panorama test is a safe, non-invasive prenatal screening tool that uses a blood sample to assess the risk of certain chromosomal conditions that may affect a baby’s health. Panorama can safely and accurately screen for many genetic conditions, including Down syndrome, Edwards Syndrome and Patau syndrome; and as of March 2014, it was expanded to screen for five microdeletions. Microdeletions are tiny missing pieces of DNA at the sub-chromosomal level, which can have serious health implications depending on the location of the deletion.
22q11.2 deletion syndrome (also known as DiGeorge syndrome or “22q”) is the most common microdeletion on Panorama’s screening panel, affecting approximately 1 out of every 2,000 births regardless of maternal age at time of pregnancy. The syndrome can cause heart defects, growth delays, immune system and endocrine issues, developmental and speech delays, and behavioral, emotional and psychiatric challenges. There is no cure for 22q, though early identification and medical intervention helps to address associated symptoms.
The Panorama test is currently the only commercially-available NIPT that uses a SNP-based approach to detect chromosomal abnormalities, delivering a result early in pregnancy that is highly accurate across fetal fractions. The test uses a simple blood draw from the mother as early as nine weeks gestation. Panorama has been validated in multiple clinical trials and is the only commercially available NIPT to consistently demonstrate high sensitivity and specificity for several major aneuploidies beyond Down syndrome, including trisomy 13 and 18, monosomy X (Turner syndrome), and triploidy (Triploidy syndrome).
Natera, Inc. is a genetic testing company that specializes in analyzing microscopic quantities of DNA for reproductive health. The mission of the company is to help families conceive and deliver. In pursuit of that mission, Natera operates a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif., providing a host of preconception and prenatal genetic testing services primarily to OBGYN physicians and in-vitro fertilization centers. In early 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. These tests were developed by Natera, and they have not been cleared or approved by the U.S. Food and Drug Administration (FDA). For more information, visit www.natera.com.