Qiagen NV, Hilden, Germany, and Natera Inc, San Carlos, Calif, have announced a partnership to develop cell-free DNA assays for use on Qiagen’s GeneReader next-generation sequencing (NGS) system.
The cell-free DNA assays will enable access to genetic testing, including prenatal screening, in hospitals and laboratories globally. Natera’s Constellation software will also be accessible for users of these and other assays, in combination with the Qiagen Clinical Insights (QCI) bioinformatics system.
Under the 10-year agreement, Qiagen will pay Natera $40 million in upfront licensing fees and prepaid royalties during the first quarter of 2018. Natera is also eligible for an additional $10 million in milestone payments, as well as ongoing royalty payments. Each company will bear its own development costs for the assays. Natera and Qiagen will establish a complete sample-to-insight workflow with the GeneReader NGS system, and will validate the sample preparation workflow using the Constellation platform.
“We are excited to partner with Natera, a global market leader in noninvasive cell-free DNA genetic testing,” says Peer M. Schatz, chief executive officer of Qiagen. “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.”
Schatz adds, “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,” says Matthew Rabinowitz, chief executive 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.”
The partnership builds on Natera’s expertise in reproductive genetics and noninvasive cell-free DNA testing. The company’s portfolio includes accurate and broad-coverage solutions for noninvasive prenatal testing (NIPT), such as Anora miscarriage testing; Horizon genetic-carrier testing; Panorama and Vistara tests for genetic disorders; Spectrum preimplantation genetic testing; and recently the Signatera research use only high-sensitivity assay for use in oncology research.
The new NIPT assays will analyze noninvasive 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 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. They will also provide personalized risk reports for healthcare and genetic counseling.