SAN CARLOS, Calif., July 18, 2016 /PRNewswire/ — Natera (NASDAQ: NTRA),a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, and Swiss-based Unilabs, one of Europe’s leading providers of clinical laboratory testing and medical diagnostic imaging services, today announced a Constellation™ technology transfer licensing agreement that enables Unilabs to offer Panorama®, Natera’s non-invasive prenatal test (NIPT).
Constellation allows laboratories worldwide to access key technologies that Natera uses in its own lab, enabling them to develop, validate, and clinically offer complex, next generation clinical genomics testing from their own facilities. The licensing agreement also includes access to Natera’s proprietary protocols, CE-marked (European Conforming) reagents, and algorithms within the Constellation software platform.
Unilabs selected Natera’s proprietary single nucleotide polymorphisms-based (SNPs) technology because of Panorama’s sensitivity, specificity, and lower false positive rate compared to other NIPT technologies. It is also one of the few NIPTs that accurately measures and reports fetal fraction for every sample. The targeted sequencing approach of the assay also has economic benefits for Unilabs’ caregivers and patients, by focusing expensive sequencing reads on specific genetic regions of interest rather than randomly across the whole genome. This enables Unilabs to achieve higher resolution and clinical performance with a lower overall sequencing cost than other approaches.
"We are delighted to be working with Natera, particularly given Natera’s unparalleled expertise in NIPT testing," commented Pierre Alain Menoud, Head of Molecular Diagnostics at Unilabs. "This agreement with Natera reinforces our commitment to providing people with the best solutions that help give care. I sincerely hope that this first step will lead to further collaboration between the two companies down the road."
"We are very pleased that Unilabs has chosen to partner with Natera to offer NIPT locally in Switzerland and other parts in Europe," said Matthew Rabinowitz, Ph.D., CEO of Natera. "Panorama is a trusted name in prenatal testing, and this continues Natera’s deployment of our Constellation platform that supports laboratories worldwide as they develop their non-invasive DNA testing capabilities."
Panorama, Natera’s non-invasive prenatal test determines the chance that a pregnancy has certain chromosomal abnormalities. It involves a simple blood draw. Panorama is the only commercially available NIPT that analyzes single nucleotide polymorphisms (SNPs) to detect for chromosomal abnormalities, allowing it to distinguish between fetal (placental) and maternal cell-free DNA. The ability to determine the difference between maternal and fetal DNA results in higher specificities than other tests. Panorama also identifies the probability of genetic conditions, including common chromosomal abnormalities, than traditional Maternal Serum Screening (MSS). These include Trisomy 21(Down Syndrome), Trisomy 18 (Edwards Syndrome), Trisomy 13 (Patau Syndrome) and Triploidy; sex chromosome abnormalities, and five microdeletions, including 22q11.2 deletion syndrome (DiGeorge Syndrome).
The Constellation software platform provides secure-hosted access to the bioinformatics algorithms that Natera has developed for clinical genomic applications in circulating cell-free DNA. The availability of these algorithms allows licensee laboratories around the world to rapidly develop and validate their own clinical genomic assays for current applications such as NIPT and non-invasive prenatal paternity testing and future products in development such as liquid biopsy assays for oncology. The Constellation software platform is developed to meet rigorous patient privacy standards and is highly scalable to accommodate the growing demand for genetic testing around the world.
Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software system. Tests include the Spectrum® pre-implantation genetic test for embryo selection during IVF; the Anora® miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier test to detect inherited mutations; and the Panorama® non-invasive prenatal test (NIPT) to detect for common chromosomal anomalies in a fetus as early as nine weeks of gestation. Each test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test.
These tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.
Natera is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit http://www.natera.com and connect on Twitter and Facebook.
Unilabs aspires to be at the heart and start of all effective treatment decisions. With over 109 laboratories, 44 imaging units and a broad catalogue of more than 2,500 diagnostic tests, Unilabs is one of Europe’s leading providers of clinical laboratory testing and medical diagnostic imaging services. Headquartered in Geneva, the Unilabs Group services sectors ranging from private and public healthcare providers to local governments, from pharmaceutical companies to the general public.
In 2015, its laboratories carried out over 106 million diagnostic tests ensuring swift, accurate diagnosis of patient samples, and over 1 million radiology exams. The importance of medical diagnostics is expanding; as focus shifts from treatment to prediction and prevention, and innovations in molecular and genetic testing continue to emerge, Unilabs aims to be at the heart of this healthcare transformation.
Unilabs Group employs more than 5,000 people worldwide, successfully operating laboratory and medical diagnostic imaging facilities in 12 countries. Its network of facilities provides it with one of the broadest geographic footprints of any clinical laboratory and medical diagnostic services provider in Europe. For more information about Unilabs, please visit: www.unilabs.com. Follow us on Twitter: @Unilabs.
This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release. These forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our ability to increase demand for Panorama, our expectations of the reliability, accuracy and performance of Panorama or of the benefits of Panorama to patients, providers and payers, or our ability to successfully implement, commercialize or scale our Constellation platform.
Additional risks and uncertainties are discussed in greater detail in the sections entitled "Risk Factors" and "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in Natera’s Form 10-Q for the quarter ended March 31, 2016. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. These documents are available for free on the company’s website at www.natera.com under the Investor Relations section, and on the SEC’s website at www.sec.gov.
SOURCE Natera, Inc.