In it for the long haul

Illumina, QIAGEN ink 15-year agreement to expand options for in-vitro diagnostics

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SAN DIEGO—Short-term partnerships are a common feature within the pharmaceutical industry, but longer ones are a bit rare, with those that span a decade rarer still. Illumina Inc. and QIAGEN N.V. established just such a partnership this week, having announced a 15-year agreement between their companies. The two organizations will focus on expanding the use and availability of next-generation sequencing (NGS)-based in-vitro diagnostic (IVD) kits, including companion diagnostics.
“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,” said 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.”
Under this arrangement, QIAGEN will receive non-exclusive rights to develop and globally commercialize IVD kits to be used in concert with Illumina's MiSeq Dx and NextSeq 550Dx Systems, as well as rights to expand the partnership to include future diagnostic systems from Illumina. The partners will work together to commercialize a menu of clinically validated workflows that unite QIAGEN's proprietary content and bioinformatics solutions and Illumina's diagnostic systems. An initial focus will be on the commercialization of oncology IVD kits to support patient management, with future fields of interest potentially including cardiology, hereditary diseases, infectious diseases and inflammatory/autoimmune diseases. In addition, Illumina and QIAGEN are assessing the possibility of QIAGEN developing and marketing companion diagnostics based on Illumina's TruSight Oncology assays.
Financial details for this partnership were not released.
The two companies are well equipped to be a force in the IVD space. QIAGEN leads the industry in molecular precision medicine—both PCR- and NGS-driven—and to date, seven therapies have been co-approved with a QIAGEN companion diagnostic assay by the U.S. Food and Drug Administration. And Illumina brings with it the MiSeq Dx and NextSeq 550Dx platforms, as well as a strong diagnostic NGS product portfolio.
“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,” Peer M. Schatz, CEO of QIAGEN, remarked in a press release about the deal. “We at QIAGEN are very pleased with this groundbreaking 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.”
This news came just a week after Illumina announced another industry partnership. The company reported on Sept. 30 that it had initiated a collaboration with the Broad Institute of MIT and Harvard to co-develop secondary genomic analysis algorithms and software. The goal is to combine the Broad Institute's industry-leading open-source GATK algorithms with Illumina's Dynamic Read Analysis for GENomics (DRAGEN) Bio-IT Platform for approaches such as small variant and large variant detection. GATK provides the ability to identify SNPs and indels in germline DNA and RNA sequencing data, and can process exomes, whole genomes, somatic short variant calling, copy number variation (CNV) and structural variation (SV). For its part, the DRAGEN Bio-It platform offers fast, accurate secondary analysis for germline and somatic single nucleotide variant, SV and CNV calling, in addition to methylation, RNA and repeat expansion workflows.
The resulting software will be open-source and offered through the Broad Institute's community support channels, such as GitHub. Illumina plans to develop proprietary, hardware-accelerated versions of the software on its DRAGEN Bio-It platform as well.
“Broad and Illumina are committed to ensuring labs of all sizes and disciplines have access to the best algorithms,” stated Dr. Anthony Philippakis, chief data officer of the Broad Institute. “By bringing our expertise together to improve on our open-source toolkit, we can offer our most advanced, comprehensive pipeline, while ensuring it remains widely available, open and accessible to the global genomics community. This is a long-term partnership; we will innovate together to drive the leading edge of novel variant calling for the advancement of genomics.”

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