The New York State Department of Health has issued a clinical laboratory permit for the CLIA-certified laboratory operated by Natera, a prenatal genetic testing firm in San Carlos, Calif. The approval enables 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 noninvasive prenatal test, preimplantation genetic screening and diagnosis (PGD), and noninvasive prenatal paternity testing.
“New York’s Clinical Laboratory Evaluation Program 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, PhD, CEO 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 noninvasive prenatal test that uses an approach based on single nucleotide polymorphisms (SNPs) 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 9 weeks’ gestation. Panorama has been validated globally in multiple clinical trials which demonstrate a combined accuracy greater than 99% in analyzing chromosomes 21, 18, 13, triploidy, and the sex chromosomes.
Panorama uses an advanced, bioinformatics-based algorithm called next-generation aneuploidy testing using SNPs (NATUS) that analyzes in a single reaction approximately 19,500 SNPs, the most informative portions of an individual’s DNA. The SNPs data 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. The 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 to be based on a SNP microarray. PGD is used during in vitro fertilization to test an embryo for extra or missing chromosomes and/or inherited diseases, to determine which embryos are most likely to result in a healthy pregnancy.
Natera also offers the only noninvasive prenatal test capable of reliably determining paternity from a maternal blood sample in the first trimester of pregnancy.
For further information, visit Natera.
