Women with Positive Serum Screening Results Through the California Prenatal Screening Program Will Have Access to Panorama at No Cost
Natera, a leading innovator in prenatal genetic testing, today announced that its non-invasive prenatal test (NIPT), PanoramaTM, will now be available to expecting parents in California at no cost as part of the California Prenatal Screening Program. Panorama was launched in March 2013 for the detection of trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and monosomy X (Turner syndrome), with detection of triploidy added in October 2013.
Under the California Prenatal Screening Program, expecting parents are offered serum screening for chromosome abnormalities and neural tube defects. Women who have a positive serum screen through the program are able to receive comprehensive follow-up prenatal services at no cost, regardless of medical insurance. These services include genetic counseling, ultrasound exam, amniocentesis and chorionic villus sampling (CVS). Non-invasive prenatal testing is being added to the program as an authorized reflex test for expecting parents who receive a positive serum screening result for Down syndrome or trisomy 18. These patients will be referred to one of approximately 140 state-approved Prenatal Diagnosis Centers (PDCs) to receive genetic counseling and a NIPT or amniocentesis/CVS.
"Since the 1980s, the California Prenatal Screening Program has made it possible for all expecting parents in the state to have access to prenatal screening and diagnostic tests. We are excited to be part of this evolution that will give patients more information in a safe, non-invasive manner,” said Matthew Rabinowitz, Ph.D., chief executive officer of Natera. “We are particularly excited to have already signed agreements with more than half of the PDCs in California, as well as most of their satellite facilities. We look forward to offering patients access to Panorama and the most reliable data possible early in their pregnancies through this program.”
Across multiple clinical trials, Panorama has been validated globally, showing highly sensitive and specific detection of trisomy 21, trisomy 18, trisomy 13, monosomy X and now triploidy. Panorama’s clinical validation data has been reported in multiple peer-reviewed publications including the May 2013 article in Prenatal Diagnosis, authored by Professor Nicolaides, which was the first demonstration of Panorama’s ability to detect triploidy. In October 2013 additional validation data was published in Fetal Diagnosis and Therapy, also authored by Professor Nicolaides, showing Panorama was able to differentiate with high accuracy between triploid and euploid cases in blinded samples.
Panorama uses a simple blood draw from the mother, examines cell-free DNA originating from both mother and fetus found in maternal blood and can be performed within the first trimester of pregnancy, as early as nine weeks, without any risk to the fetus. Panorama’s technology analyzes, in a single reaction, 19,488 single nucleotide polymorphisms (SNPs), which are the most informative portions of an individual’s DNA. It utilizes the Next-generation Aneuploidy Testing Using SNPs algorithm, an advanced version of Natera’s proprietary informatics.
Natera is a leading genetic testing company that has developed a proprietary bioinformatics-based technology to deliver accurate and comprehensive high-throughput testing for reproductive indications from tiny quantities of DNA. Natera operates a CLIA-certified laboratory in San Carlos, Calif., providing a host of preconception and prenatal genetic testing services. Test offerings include pre-implantation genetic diagnosis to identify chromosomal anomalies or inherited genetic conditions in embryos generated during an IVF cycle; products-of-conception testing following miscarriage to rapidly and extensively analyze fetal chromosomes in order to understand the cause of the pregnancy loss; non-invasive prenatal testing to determine paternity; carrier screening tests to detect whether parents carry genetic variations that may result in disease in the child; and Panorama, a safe, simple test for pregnant women that identifies the most common chromosomal anomalies in a fetus as early as nine weeks. Natera's clinical trial for non-invasive screening of fetal chromosomal anomalies is funded by the NIH and is being conducted by the leaders in maternal-fetal medicine in the United States. For more information, visit www.natera.com.
Monica May, 619-308-6542
David Schull, 212-845-4271
Solomon Moshkevich, 650-249-9090