SALT LAKE CITY & SAN CARLOS, CALIF. — ARUP Laboratories, a leading national clinical and anatomic pathology reference laboratory, and Natera, a leading innovator in reproductive and prenatal genetic testing, today announced that Natera’s non-invasive prenatal screening test, Panorama™, is available to ARUP clients nationwide.
The test is available for the detection of trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and select sex chromosome abnormalities, such as monosomy X (Turner’s syndrome).
“Demand for non-invasive prenatal testing continues to grow, especially following the recommendation by the American Congress of Obstetricians and Gynecologists of use of the tests in high-risk pregnancies,” said Edward Ashwood, M.D., president and CEO of ARUP. “We are very pleased to partner with Natera to offer non-invasive prenatal testing to physicians and patients.”
Added Matthew Rabinowitz, Ph.D., chief executive officer of Natera, “Panorama has shown it has superior sensitivity and specificity compared to other non-invasive prenatal tests currently available, demonstrating that it is the best non-invasive prenatal testing choice for pregnant women today. We are pleased to partner with ARUP to enable Panorama to be offered to a broad network of hospitals, granting even more patients access to our best-in-class test.”
ARUP is a national reference laboratory that provides tests to an extensive network of U.S.-based hospitals. ARUP’s clients include more than half of the nation’s university teaching hospitals and children’s hospitals, as well as many other hospital networks and groups. Hospital laboratories provide patients with key tests that improve patient care, and are expected to play an increasingly important role in patient treatment as the use of molecular diagnostics grows. Hospital labs can order Panorama via ARUP’s test code #2007537.
In clinical validation studies, Panorama demonstrated a sensitivity of greater than 99% when detecting common chromosomal abnormalities such as trisomy 21, trisomy 18 and trisomy 13; and 92% when detecting monosomy X. In addition, the Panorama test has had no false positives for all the syndromes tested in three clinical trials. The test uses fetal cell-free DNA found in maternal blood and works as early as nine weeks gestation. Panorama’s clinical validation data was presented at the annual Society of Maternal Fetal Medicine Meeting on Feb. 15, 2013.
Panorama’s technology analyzes, in a single reaction, 19,500 single nucleotide polymorphisms (SNPs), which are the most informative portions of an individual’s DNA. It utilizes the NATUS [Next-generation Aneuploidy Testing Using SNPs] algorithm, an advanced version of Natera’s proprietary informatics. Panorama has been validated globally and is currently being evaluated in several other clinical trials for the detection of genetic disorders, including trisomy 21, trisomy 18, trisomy 13, monosomy X, XXY, XYY, XXX and triploidy. The test uses a simple blood draw from the mother and can be performed within the first trimester of pregnancy, as early as nine weeks, without any risk to the fetus.
Natera is a genetic testing company that has developed a proprietary bioinformatics-based technology (NATUS) 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 PreNATUS 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.
About ARUP Laboratories
Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation’s top university teaching hospitals and children’s hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology®.