Abstract
Two leaders in genomics and molecular analysis, Illumina and QIAGEN, have announced a 15-year partnership that the companies say is aimed at increasing the availability and use of NGS-based in vitro diagnostics (IVDs) for precision medicine applications.
Under the terms of the agreement, Qiagen has received non-exclusive rights to develop and commercialize diagnostic kits to be used on Illumina's MiSeq Dx and NextSeq 550Dx sequencing systems, with Illumina also holding the right to expand the relationship to future diagnostic systems it develops. The agreement also includes a provision for Qiagen to develop immunotherapy companion diagnostics based on Illumina's TruSight Oncology assays.
“The partnership between QIAGEN and Illumina accelerates the adoption of routine clinical NGS testing by bringing together synergies of QIAGEN's expertise in the development and commercialization of IVD products, its leadership position in precision medicine including regulatory experience, best-in-class clinical decision-making informatics, sample technologies, and IVD assay development with Illumina's best-in-class NGS instrumentation and related chemistry and global commercial channels,” Jonathan Arnold, vice president, head of partnering for Precision Diagnostics, Oncology and PPD Franchise at QIAGEN, told Clinical OMICs. “This is a highly complementary package and will speed the decentralization of NGS testing to routine clinical (community) labs while maintaining a strong presence in central labs.”
According to the companies, the initial focus of the partnership will be on the commercialization of oncology diagnostic kits to aid clinical patient management. In the future, the diagnostics partnership may expand to other clinical areas such as cardiology, hereditary diseases, infectious diseases, and inflammatory and autoimmune diseases.
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“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 in a press release. “Our partnership with Qiagen will complement Illumina's TSO 500 family with additional testing menu options, accelerating NGS adoption in oncology patient management.”
For Qiagen, the deal will allow the company to develop an array of diagnostic tests designed to run on Illumina's Dx line of sequencers, with the aim of increasing the footprint of both companies in the clinical diagnostics space. According to Qiagen, the partnership with Illumina further strengthens its presence in molecular precision medicine and in immune-oncology, which currently includes 25 master collaboration agreements with pharma and biotech partners—agreements that have yielded seven co-approvals of a therapeutic and companion diagnostic.
“Immuno-oncology is a promising field for QIAGEN, and, beyond our partnership with Bristol-Myers Squibb to develop gene expression profiles using NGS technology for immune-oncology therapies, we are currently exploring combinatorial testing with multiple biomarkers across DNA and RNA,” Arnold added.
For its part, Illumina has set its sights firmly on influencing and improving precision clinical care via its MiSeq Dx and NextSeq 550Dx systems, as well as other technologies and assays. With its focus on reducing the cost of sequencing a whole genome to the $100 range, the company is working toward making NGS testing for patients a more integral part of everyday clinical care across a range of indications.