SAN CARLOS, Calif. & DALLAS--(BUSINESS WIRE)--Natera, a leading innovator in prenatal genetic testing, today announced the initiation of a distribution partnership with ProPath, a wholly physician-owned provider of pathology services to clinicians and medical facilities in the United States, for its Panorama™ non-invasive prenatal screening test (NIPT).
Panorama has been validated globally in multiple clinical trials and is the only NIPT to consistently demonstrate high sensitivity and specificity for all major aneuploidies beyond Down syndrome, including trisomy 13 (Patau syndrome), trisomy18 (Edwards syndrome), triploidy and sex chromosome abnormalities. Panorama is now also able to screen for microdeletions, such as the 22q11.2 deletion (DiGeorge syndrome), which is caused by a small deletion on chromosome 22. DiGeorge results in a range of developmental problems, such as heart disease, cleft palate, learning disabilities as well as weak immune systems. The microdeletions screened for by Panorama occur with a combined incidence of approximately 1 in every 1,000 births, occur equally across all maternal ages, and for younger mothers are more prevalent than Down syndrome.
“We have seen increasing demand for non-invasive prenatal testing, and we are proud to offer Panorama with its ability to more accurately and comprehensively screen for abnormalities than conventional tests,” said Kenneth E. Youens, M.D., director of women’s health for ProPath. “We look forward to rolling out this test quickly and making it available to our medical facilities and clinicians nationwide.”
Matthew Rabinowitz, Ph.D., chief executive officer of Natera, said, “ProPath is an excellent partner for us, with a wide network in the United States as we continue to expand access to Panorama. We look forward to working with ProPath to reach more patients as we continue to investigate all potential applications for this promising technology.”
Panorama uses a simple blood draw from the mother, examines cell-free DNA found in maternal blood originating from both mother and fetus, 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, 19,500 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. 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.
ProPath® is a team of pathologists recruited from top-tier medical centers and academic institutions around the country. ProPath® has surrounded its physicians with an unsurpassed, internationally-recognized laboratory utilizing a proprietary tracking system for every patient specimen. As with all medical specialties, the quality of a cancer diagnosis is directly related to the education, talent and experience of the rendering physician. The ProPath® team of board-certified and subspecialty-trained pathologists are the experts you want rendering your diagnosis. For more information about ProPath®, please visit www.propath.com. Also, follow us on Facebook and Twitter.
Natera Inc. is a genetic testing company that specializes in analyzing microscopic quantities of DNA for reproductive health indications. The mission of the company is to help families conceive and deliver. In pursuit of that mission, Natera operates a CLIA-certified laboratory in San Carlos, Calif., providing a host of preconception and prenatal genetic testing services primarily to OBGYN physicians and in-vitro fertilization centers. In early 2013, the company launched Panorama™, a safe, simple test for pregnant women that screens for the most common chromosomal anomalies in a fetus as early as nine weeks of gestation. These tests were developed by Natera, a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA), and they have not been cleared or approved by the U.S. Food and Drug Administration (FDA).
For more information, visit www.natera.com.