SAN DIEGO, HILDEN, Germany & GERMANTOWN, Md.—Commitment is the name of the game of the latest agreement between Illumina Inc. and QIAGEN N.V., as the companies have inked a 15-year partnership for the development of next-generation sequencing (NGS)-based in-vitro diagnostic (IVD) kits for patient management. Under the auspices of this deal, QIAGEN will aim to develop a variety of IVD tests based on Illumina’s Dx sequencers.
The partners’ combined reach should not be understated. QIAGEN is making its mark in molecular precision medicine—particularly PCR- and NGS-driven precision medicine—both singularly and in concert with partners; the company has established more than 25 collaboration agreements for the development of companion diagnostics, and seven therapies have been co-approved by the FDA with a QIAGEN companion diagnostic. For its part, Illumina is an industry leader in diagnostic NGS, thanks to its MiSeq Dx and NextSeq 550Dx platforms, with a global reach and a portfolio that spans a number of clinical applications.
“Bringing together our highly complementary capabilities marks an important milestone to advance the use of NGS technologies in clinical decision-making and our shared vision of using this powerful technology to improve the outcomes for patients worldwide,” said Peer M. Schatz, CEO of QIAGEN. “We at QIAGEN are very pleased with this ground-breaking partnership and this first step in what we hope to be a long and productive relationship that capitalizes on combining our unique strengths. This partnership becomes a key cornerstone of our NGS strategy, which continues to include our universal solutions for use with any sequencer as well as the GeneReader NGS System for use primarily with smaller, targeted gene panels. Through this partnership, we look forward to creating significant benefits for customers and for both parties, as well as to allowing QIAGEN to maximize our opportunities as a company creating value by offering sample-to-insight solutions.”
Under the agreement, QIAGEN will receive non-exclusive rights to develop and globally commercialize IVD kits for use in concert with Illumina’s MiSeq Dx and NextSeq 550Dx systems. This deal also covers rights for expansion of the agreement to include future Illumina diagnostic systems, and the companies are looking into options for QIAGEN to develop and market companion diagnostics based on Illumina’s TruSight Oncology (TSO) assays.
“We are committed to expanding the range of clinical use cases addressed by genomic sequencing by enabling partners to deliver IVD tests and companion diagnostics on Illumina’s Dx instruments,” remarked Francis deSouza, CEO of Illumina. “Our partnership with Qiagen will complement Illumina’s TSO 500 family with additional testing menu options, accelerating NGS adoption in oncology patient management.”
“Strong partnerships are something that QIAGEN believes are a key component of our business and success,” says Jonathan Arnold, vice president, head of Oncology and Precision Diagnostics (OPDx) at QIAGEN. “We understand that we’re not able to do everything, and we always seek out partners in key markets for us where they have a dominant position, and that’s certainly Illumina from an NGS-sequencer standpoint. And the beauty of this is it allows both companies to really leverage each other’s capabilities.”
The initial focus for the agreement will be in oncology, a popular field for companion diagnostics, and one that Arnold notes is “one of the largest markets for NGS next to reproductive health.” Beyond that, additional indications of focus could include cardiology, infectious diseases, hereditary diseases and inflammatory/autoimmune diseases.
Arnold calls it an “IVD development agreement,” and notes that QIAGEN will be responsible for commercialization of any IVD products, while Illumina will be responsible for commercializing the related sequencers and sequencing consumables.
He adds that QIAGEN considers NGS to be a disruptive, dominant technology that is a “fundamental tool” for enabling precision medicine, one that is here to stay.
“We segment the overall NGS market into, I’d say, four top-line market segments: clinical (including reproductive health testing), applied testing, academic testing and pharma. We estimate the overall total NGS market to be between a $4-billion to $5-billion market now, growing roughly 12 percent to 16 percent year over year,” Arnold tells DDNews. “Within that, I would define the clinical segment—including tools, applications and testing across these segments—as approximately 35 percent of that total NGS market. IVD testing is an emerging subsegment of the clinical market. One of the critical points is it’s actually growing faster than the overall NGS market; we estimate that that market is growing at about 18 percent, so it’s a very attractive segment based on its growth.”