Approval Includes the Panorama™ Non-Invasive Prenatal Test, Preimplantation Genetic Diagnosis (PGD) and Non-Invasive Prenatal Paternity Testing
Natera, a leading innovator in prenatal genetic testing, today announced that the New York State Department of Health has issued a clinical laboratory permit for the company’s CLIA-certified laboratory in San Carlos, Calif., enabling the company to make its portfolio of next-generation preconception and prenatal tests available to expecting parents in New York State. The approval includes the Panorama™ non-invasive prenatal test (NIPT), pre-implantation genetic screening and diagnosis (PGD), and non-invasive prenatal paternity testing.
“New York’s Clinical Laboratory Evaluation Program (CLEP) is one of the most rigorous assessments in the nation, and this laboratory permit recognizes the accuracy, reliability and high standard of quality of our next-generation genetic testing technologies,” said Matthew Rabinowitz, Ph.D., chief executive officer of Natera. “Our launch in New York is a significant milestone because Natera is now the only company to offer this range of services to health professionals and expecting parents in New York.”
The Panorama™ test is the only NIPT available today that uses a SNP-based approach to detect chromosomal abnormalities, delivering a result early in pregnancy that is accurate across fetal fractions. The test uses a simple blood draw from the mother as early as nine weeks gestation. Panorama has been validated globally in multiple clinical trials and is the only noninvasive prenatal test to consistently demonstrate high sensitivity and specificity for all major autosomal aneuploidies beyond Down syndrome, including trisomy 13 and 18. The Panorama™ test is also the only NIPT capable of detecting triploidy, a severe chromosomal syndrome which occurs in over 10% of spontaneous miscarriages and can be associated with persistent gestational trophoblastic neoplasia that may require close and ongoing physician follow up to ensure the best maternal outcome possible.
Panorama uses an advanced, bioinformatics-based algorithm called Next-generation Aneuploidy Testing Using SNPs, that analyzes in a single reaction approximately 19,500 single nucleotide polymorphisms (SNPs), the most informative portions of an individual’s DNA. These SNPs are combined with genetic information from the parents as well as data from the Human Genome Project, to generate hypotheses of all the potential fetal genotypes. These billions of hypotheses are then compared to the actual cell-free DNA measurements to determine the presence or absence of a chromosomal abnormality.
Natera’s PGD test, commercially available since 2009, was the first 24-chromosome aneuploidy test on the market based on SNP microarray. PGD is used during in vitro fertilization (IVF) to test an embryo for extra or missing chromosomes or pieces of chromosomes, and/or inherited diseases, to determine which embryos are most likely to result in a healthy pregnancy.
Natera also offers the only non-invasive prenatal test in the world capable of reliably determining paternity from a maternal blood sample in the first trimester of pregnancy.
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 of gestation. 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. In August, Natera was selected by the World Economic Forum as a Technology Pioneer for innovations in prenatal care. For more information, visit www.natera.com.
Lena Evans, 212-845-4262
Solomon Moshkevich, 650-249-9090