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Natera, Qiagen Partner to Develop Cell-Free DNA Assays for Prenatal Screening

NEW YORK (GenomeWeb) – Natera and Qiagen announced after the close of the market on Monday that they have signed a 10-year agreement to develop cell-free DNA assays for use on Qiagen's GeneReader next-generation sequencing system, for the purposes of prenatal screening.

The financial terms of the agreement call for Qiagen to pay Natera $40 million in up-front licensing fees and prepaid royalties in the first quarter of 2018. Natera is also eligible for an additional $10 million in milestone payments and ongoing royalty payments. Each company will bear its own development costs for the assays.

The assays will be designed for use with maternal blood samples and will build on Qiagen's PaxGene cell-free DNA collection and sample processing technology. The tests are expected to selectively differentiate fetal placental DNA from maternal background DNA to test whether a baby is at higher risk for common genetic disorders.

The partners will further establish a complete sample-to-answer workflow on the research-use-only GeneReader NGS system and will validate the sample prep workflow using Natera's Constellation software, which will also be accessible to assay users through Qiagen's Clinical Insights bioinformatics software. The software will also provide personalized risk reports for healthcare and genetic counseling.

"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," Qiagen CEO Peer Schatz said in a statement. "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 added that the new assays and Natera's Constellation software "will substantially increase [GeneReader's] value and utility for a broader range of customers beyond our current focus on oncology."

Natera CEO Matthew Rabinowitz noted that Qiagen's global reach "will help [Natera] capitalize on the emergence and power of next-generation sequencing globally, and make these assays broadly accessible to hospital systems and laboratories worldwide."