Natera, Inc. has announced two new partnerships to launch its Panorama™ non-invasive prenatal screening test (NIPT) outside of the United States.
The Joaquim Chaves Group will manage the distribution of Panorama in Portugal, and Bangkok Cytogenetics Center will manage its distribution in Thailand.
“There is a strong demand for accurate and comprehensive prenatal screening tests outside of the U.S., and these two partnerships are an integral part of our mission to fill this need worldwide,” said Matthew Rabinowitz, Ph.D., chief executive officer of Natera.
Panorama™ has been validated globally in multiple clinical trials and has consistently demonstrated high sensitivity and specificity for all major aneuploidies beyond Down syndrome, including trisomy 13 (Patau syndrome) and 18 (Edwards syndrome), as well as sex chromosome abnormalities.
Panorama is also the only commercially available NIPT capable of screening for triploidy. A severe chromosomal syndrome, triploidy occurs in over 10% of spontaneous miscarriages. In some cases, it can be associated with persistent gestational trophoblastic neoplasia that may require close and ongoing physician follow up to ensure the best maternal outcome possible.
“Prenatal genetic screening and diagnosis is the focus of the Joaquim Chaves Group’s genetics department,” said Ana Rita Tarelho from the Clinical Genetics Department at Joaquim Chaves Group. “We have a history of being the first and striving for excellence in all of our work, so it is only natural for us to use Panorama, the most accurate non-invasive prenatal test in the market.”
Dr. Vitaya Titapant, the chief of the Maternal-Fetal Medicine Unit, Department of Obstetrics/Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, said, “Fetal abnormalities, particularly in older women, are a significant challenge for us. We have implemented a number of methods to screen for these abnormalities, however invasive methods, including CVS and amniocentesis, put patients at risk for miscarriage, and non-invasive serum screening has a low detection rate and a high false positive rate. After trying the various non-invasive prenatal tests on the market today, we have selected Panorama because of its advantages. We now expect that this screening test will be used more extensively all over Thailand.”
Panorama analyzes cell-free DNA in maternal blood using a simple blood draw and can be performed as early as nine weeks without any risk to the fetus. Panorama uses an advanced, bioinformatics-based algorithm called NATUS [Next-generation Aneuploidy Testing Using SNPs] that analyzes in a single reaction approximately 19,500 single nucleotide polymorphisms (SNPs), within the most informative portions of an individual’s DNA.
These SNPs are combined with genetic information from the parents and data from the Human Genome Project to generate hypotheses of 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 in the fetus.
Panorama is the only NIPT commercially available using a SNP-based approach, delivering reliable result early in pregnancy even at fetal fractions as low as 3.8%, which is important as low fetal fractions affect up to 25% of pregnancies between 9 and 14 weeks of gestation.
In contrast to traditional genetic testing such as amniocentesis or chorionic villus sampling, Panorama causes no risk to the fetus.
In published clinical trials, Panorama has demonstrated a sensitivity of greater than 99% for trisomy 21, trisomy 18 and trisomy 13, 92% for monosomy X, and a less than 0.1% false positive rate for all syndromes tested.