US-based genetic testing company Natera has received CE Mark approval for its cloud-based analytical software, allowing the company to license and sell its software throughout the EU to support laboratory partners who will run Panorama in their own laboratories as an in vitro diagnostic.
Natera chief technology officer Jonathan Sheena said: "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 cloud-based analytical software, which is applicable to multiple applications, including Natera’s Panorama non-invasive prenatal test (NIPT), will allow for the secure delivery of Natera’s analytical services to laboratory customers in countries worldwide that accept the CE Mark.
According to Natera, the company’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 its genomic technology in their own facility, for which Natera is pursuing additional regulatory approvals, as needed.
The company expects to include a CE Mark on the Panorama test reports that are generated in its laboratory in San Carlos, California, for patients in the EU beginning in the third quarter of 2014 and following a separate filing.