Qiagen N.V., a world leader in providing sample to insight molecular solutions, and Natera, Inc., a leading developer of NGS assays, announced a partnership to develop cutting-edge cell-free DNA assays for use on Qiagen’s GeneReader NGS System.

These cell-free DNA assays will now be developed for use on the GeneReader NGS System, the first fully integrated sample to insight NGS solution, and designed to enable these type of tests, including prenatal screening, for hospitals and laboratories globally. Natera’s Constellation software would also be accessible for users of these and other assays in combination with the Qiagen Clinical Insights (QCI) bioinformatics solution.

“We are excited to partner with Natera, a global market leader in non-invasive cell-free DNA genetic testing. Through this strategic partnership, we are planning to offer assays that provide significant clinical and economic value backed by extensive validation data and large clinical studies. We intend to make these assays available on the GeneReader NGS System to laboratories around the world that are very eager to bring in-house genetic testing across several applications, including prenatal screening,” said Peer M. Schatz, chief executive officer of Qiagen N.V. “The addition of these assays, along with Natera’s Constellation software, will substantially increase the system’s value and utility for a broader range of customers beyond the current menu focused on oncology.”

“This strategic partnership is an important milestone in the development of Natera, and we welcome the opportunity to partner with Qiagen since both companies share a commitment to providing customers with actionable and often life-changing clinical insights,” said Matthew Rabinowitz, CEO of Natera. “We are combining Natera’s molecular and clinical experience in NGS content development with Qiagen’s expertise in offering a complete and integrated NGS workflow to offer Sample to Insight testing leveraging Natera’s Constellation cloud platform. We also believe the global reach of Qiagen will help us capitalize on the emergence and power of next-generation sequencing globally, and make these assays broadly accessible to hospital systems and laboratories worldwide.”

The partnership builds on Natera’s expertise in reproductive genetics and non-invasive cell-free DNA testing. This includes highly accurate and broad-coverage solutions for non-invasive prenatal testing (NIPT) such as Panorama and Vistara, Horizon genetic-carrier testing, Spectrum preimplantation genetic testing (PGD/PGS), Anora miscarriage testing, and recently the Signatera (RUO) high-sensitivity assay for use in oncology research.

The new NIPT assays will analyze non-invasive maternal blood samples and reflect the power of liquid biopsy to gain insights. Building on Qiagen’s leading PAXgene blood cell-free DNA collection and sample processing technology, which is fully automated and integrated into the GeneReader NGS workflow, the tests are expected to selectively differentiate fetal placental DNA from the background of the mother’s DNA to test whether a baby is at higher risk for common genetic conditions. The Sample to Insight workflow will also provide personalized risk reports for healthcare and genetic counseling.

Under the 10-year agreement, Qiagen will pay Natera $40 million in upfront licensing fees and prepaid royalties in the first quarter of 2018. Natera is also eligible for an additional $10 million of milestone payments, as well as ongoing royalty payments. Each company will bear its own development costs for the assay. Natera and Qiagen will establish a complete sample to insight workflow with the GeneReader NGS System and validate the sample preparation workflow using the Constellation platform.

The GeneReader NGS System provides the first true Sample to Insight NGS workflow for laboratories worldwide to take advantage of the power of NGS technology. The system’s integrated bioinformatics for analysis and interpretation of NGS data, as well as a family of gene panels under the GeneRead QIAact brand, enable laboratories to identify gene variations linked to cancers and gain actionable molecular insights. Qiagen continues to add content for GeneReader, with a pipeline of potential future tests in areas such as oncology, prenatal testing, infectious disease genotyping, and customized panels for specific needs. Integrated bioinformatics provide streamlined, cloud-based analysis and interpretation. The current version of the GeneReader NGS System is available in the United States for research use only (RUO).

Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic disease.