QIAGEN and Illumina Partner to Deliver Sequencing-Based In-Vitro...

QIAGEN and Illumina Partner to Deliver Sequencing-Based In-Vitro Diagnostic (IVD) Tests

By Pharma Tech Outlook | Monday, December 16, 2019

San Diego, California, Hilden, Germany and Germantown, Maryland: Illumina, Inc. (NASDAQ: ILMN) and QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced a 15-year partnership intended to broaden the availability and use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management.

The agreement grants QIAGEN non-exclusive rights to develop and globally commercialize IVD kits to be used together with Illumina’s MiSeq™ Dx and NextSeq™ 550Dx Systems. The agreement also includes rights for expansion of the partnership on future Illumina diagnostic (Dx) systems. Both partners are also exploring opportunities for QIAGEN to develop and market companion diagnostics based on Illumina’s TruSight Oncology (TSO) assays that enable comprehensive genomic profiling of tumor samples in immunotherapy.

Illumina and QIAGEN will cooperate to commercialize a menu of clinically validated workflows that combine QIAGEN’s proprietary content and bioinformatics solutions. The partnership will initially focus on commercializing oncology IVD kits to support patient management and may expand in the future to include additional clinical diagnostic fields, such as cardiology, hereditary diseases, infectious diseases, as well as inflammatory and autoimmune diseases.

“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.”

“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, Chief Executive Officer 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.”

Bringing together highly complementary capabilities

Through this partnership, QIAGEN endeavors to build a broad menu of IVD tests on Illumina’s Dx sequencers by leveraging its market leading companion diagnostic capabilities and Sample to Insight solutions, thereby enhancing both companies’ channel reach and presence in the IVD market.

QIAGEN is an established global leader in molecular (PCR and NGS-driven) precision medicine given its portfolio of more than 25 master collaboration agreements with pharmaceutical and biotechnology companies to co-develop and gain regulatory approvals for companion diagnostics. So far, seven therapies have received FDA co-approval with a QIAGEN companion diagnostic assay.

With global availability of the MiSeq Dx and NextSeq 550Dx platforms, Illumina has a robust diagnostic NGS product portfolio capable of covering a broad range of clinical applications designed for a variety of clinical lab settings. As NGS testing begins to play a more significant role in patient care, Illumina is committed to providing clinical solutions, both Illumina developed and partner driven, that support the diagnosis and management of human diseases.

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