Natera, Inc., a leader in non-invasive genetic testing, today announced its cloud-based analytical software has achieved Conformité Européenne (CE) marking. This registration provides a significant step for Natera to license and sell its software throughout the European Union to support laboratory partners who will run Panorama in their own laboratories as an in vitro diagnostic (IVD).
“The CE Mark is a milestone that reflects the quality and reliability of Natera's technology”
“The CE Mark is a milestone that reflects the quality and reliability of Natera's technology,” said Jonathan Sheena, chief technology officer of Natera. “This will help us to meet the needs of our laboratory partners in the EU who want to implement Natera’s proprietary algorithms for clinical use.”
The proprietary software is a cloud-based platform that will allow for the secure delivery of Natera’s analytical services to laboratory customers in countries worldwide that accept the CE Mark. The flexible platform is designed to enable access in a way that is highly secure and easy to integrate and scale. The new software is applicable to multiple applications, including Natera’s flagship Panorama NIPT.
CE marking provides assurance to EU consumers that the product has been developed and manufactured to meet EU safety, health and environmental protection requirements. Natera’s laboratory partners in the EU and in other countries that accept the CE Mark will be able to access the software when they are able to run Natera’s genomic technology in their own facility, for which Natera is pursuing additional regulatory approvals, as needed.
Natera expects to include a CE Mark on the Panorama test reports that are generated in the company’s laboratory in San Carlos, Calif., for patients in the EU beginning in the third quarter and following a separate filing.
Natera is a genetic testing company that designs targeted assays to analyze tiny quantities of DNA. The mission of the company is to help families diagnose and manage genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif., currently offering a host of preconception and prenatal genetic testing services primarily to OBGYN physicians and in vitro fertilization centers. In 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. Tests developed by Natera have not been cleared or approved by the U.S. Food and Drug Administration (FDA). For more information, visit www.natera.com.
GOLD PR for Natera
Shari Gold, 714-251-0375
Michael Hromadik, 858-442-2215