Natera, a leading innovator in prenatal genetic testing, and LifeLabs Medical Laboratory Services (LifeLabs), a Canadian company with over 50 years’ experience in laboratory testing and management, today announced a distribution partnership for Natera’s non-invasive prenatal screening test, Panorama™. Panorama was launched in March 2013 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 syndrome). The detection of triploidy was added in August 2013.
“There is tremendous demand by patients for non-invasive prenatal testing, and we are pleased to be able to offer these tests at our laboratories in Canada,” said Dr. Doug Tkachuk, Chief Medical and Quality Officer at LifeLabs. “We are especially glad to be partnering with Natera to give patients access to Panorama™, which we believe offers the best data possible across most indications.”
“We continue to gain momentum with our global rollout by partnering with leading organizations, such as LifeLabs, and are glad to now expand into Canada,” said Matthew Rabinowitz, Ph.D., Chief Executive Officer of Natera. “We look forward to bringing patients access to the most accurate information possible early in pregnancy, while also expanding the offerings of the test through continued investigation.”
Panorama uses a simple blood draw from the mother to examine cell-free DNA found in maternal blood originating from both mother and fetus. The test can be performed as early as nine weeks of gestation without any risk to the fetus. Panorama’s technology analyzes 19,488 single nucleotide polymorphisms (SNPs) in a single reaction. SNPs are the most informative portions of an individual’s DNA. Panorama™ utilizes the Next-generation Aneuploidy Testing Using SNPs algorithm, an advanced version of Natera’s proprietary informatics.
Across multiple clinical trials, Panorama has been validated globally for trisomy 21, trisomy 18, trisomy 13 and monosomy X with 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. Panorama’s clinical validation data was presented at the annual Society of Maternal Fetal Medicine Meeting on Feb. 15, 2013. The most recent independently-led, blinded study was published in May 2013 in Prenatal Diagnosis from author Professor Nicolaides, M.D., and The Fetal Medicine Foundation. This study also demonstrated the ability to detect triploidy. Panorama is currently being evaluated in several other clinical trials for the detection of other genetic disorders, including XXY, XYY, and XXX.
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. Natera's clinical trial for non-invasive screening of fetal chromosomal anomalies is funded by the NIH and is being conducted by leaders in maternal-fetal medicine in the United States. For more information, visit www.natera.com.
LifeLabs provides laboratory testing services, which help physicians and other healthcare professionals diagnose, treat, monitor and prevent disease in patients. LifeLabs employs approximately 4,000 professionally trained staff, who deliver more than 60 million tests annually, serving over 11 million patients and 26,000 healthcare providers. LifeLabs has operated in Canada for over 50 years and is owned by Borealis, a global leader in infrastructure investing, with assets in energy, transportation and infrastructure buildings, including long-term care facilities and hospitals, pipelines and telecommunications. For information, visit www.lifelabs.com.
Solomon Moshkevich, 650-249-9090 ext. 376
LifeLabs Medical Laboratory Services
Stephanie Sayer, 416-675-4530 ext. 2015