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Qiagen, Lilly Ink CDx Development Pact Targeting Multiple DNA, RNA Markers

This article has been updated from a previous version as Qiagen clarified an earlier statement regarding its acquisition of PrimeraDx.

NEW YORK (GenomeWeb) — Qiagen said today that it is collaborating with Eli Lilly to co-develop universal and modular assay panels to simultaneously analyze DNA and RNA biomarkers targeting multiple cellular pathways in common cancer types.

In addition, Qiagen disclosed that it recently acquired Boston-area molecular diagnostics startup PrimeraDx, and will be using that company's multi-modal, multi-analyte testing system, called Modaplex, as part of the collaboration with Lilly.

"Certain applications in biomarker development for tailoring oncology therapeutics require the combined analysis of DNA and RNA, and this collaboration provides a multi-modal, multi-analyte solution that can process multiple sample types and biomarkers in a single test," Richard Gaynor, senior vice president of oncology-clinical product development and medical affairs at Lilly, said in a statement.

The Modaplex platform was formerly called ICEPlex and received 510(k) clearance from the US Food and Drug Administration in December along with PrimeraDx's first assay for Clostridium difficile.

However, PrimeraDx had also been developing ICEPlex for oncology and CDx development, and in fact already has had its own diagnostics development partnership in place with Lilly since 2012.

According to a Qiagen spokesperson, Qiagen has acquired all assets of PrimeraDx.

The new collaboration with Lilly is Qiagen's fourth CDx development project with the drugmaker. Qiagen's Therascreen KRAS RGQ PCR Kit was approved by the FDA in 2012 as a companion diagnostic to detect KRAS gene mutations in metastatic colorectal cancer patients and to indicate which patients would benefit from a tailored oncology therapy marketed by Lilly and Bristol-Myers Squibb. In 2011, Qiagen and Lilly partnered to develop a companion diagnostic that evaluates a gene mutation that plays a role in some blood cancers. And in 2013, Qiagen announced a third project, building on a master collaboration agreement, to create a companion diagnostic to guide use of an undisclosed Lilly oncology compound.

"We are excited to add a new stage to our successful collaboration with Lilly, this time co-developing a broad panel of molecular assays covering a range of biomarkers with diverse nucleic acid analytes and modalities to guide the use of tailored therapies," Qiagen CEO Peer Schatz said in a statement. "We believe our technology can enhance Lilly's development of innovative therapies for the benefit of cancer patients. In addition to a broad portfolio of PCR-based assays targeting more than 25 biomarkers, Qiagen's personalized healthcare offering has expanded to include universal solutions using next-generation sequencing and now also a unique and proprietary multi-modal, multi-analyte testing technology."