Qiagen, a Netherlands-based holding company, has entered into a master collaboration agreement with the Swiss pharmaceutical company Novartis to enable the development and commercialization of companion diagnostics to be paired with existing Novartis pharmaceutical products as well as compounds in its development pipeline.
The non-exclusive agreement with Novartis creates a framework for collaborations that would include developing Qiagen companion diagnostics to guide treatment decisions for Novartis pharmaceutical products. The scope of the collaboration can cover all Qiagen platforms, indications or biomarkers.
Financial terms of the agreement have not been disclosed.
The collaboration with Novartis is the ninth master framework agreement reached by Qiagen for the development of companion diagnostics, underscoring its position as the preferred partner to pharma companies.
Qiagen is pursuing more than 20 collaborative projects with pharma and biotech companies to develop, validate and market companion diagnostics designed to guide the treatment of cancers and other diseases. Around the world, Qiagen already markets companion diagnostics based on molecular biomarkers, and the company has a growing portfolio of novel targets in development.
The companion diagnostic programs span a range of platforms for molecular testing. A number of the diagnostics are real-time PCR assays for analysis on Qiagen's Rotor-Gene Q, a component of the QIAsymphony family of automated instruments. For example, Qiagen received FDA approvals in 2012 and 2014 for its therascreen KRAS RGQ PCR Kit in colorectal cancer and in 2013 for the therascreen EGFR test in NSCLC—both running on Rotor-Gene Q.
In addition, QIAGEN is a developer of universal solutions for NGS platforms, which include a broad number of gene panels that cover an extensive range of cancer-related genes and gene regions. A recent addition to the portfolio of Qiagen platforms for companion diagnostics is the multi-modal, multi-analyte Modaplex system, which enables laboratories to analyze multiple sample types simultaneously for dozens of DNA and RNA biomarkers.
Qiagen also is pioneering companion diagnostics based on blood or other fluid samples for medical situations that make surgical biopsies difficult. Qiagen has collaborations to develop first-in-class, non-invasive tests for genetic biomarkers using liquid biopsies, which use blood or other fluid samples rather than tissue samples. Qiagen's liquid biopsy technologies include industry-leading kits for processing free-circulating DNA and RNA, genomic material from single cells, or exosomes circulating in the body.