QIAGEN Signs Ninth Master Collaboration Agreement for Companion Diagnostics

17 Nov 2014
Sarah Thomas
Associate Editor

Industry news

QIAGEN N.V. has announced it has entered into a master collaboration agreement with the Swiss pharmaceutical company Novartis AG 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 were not 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.

“We are very pleased to be working with Novartis in the development and commercialization of companion diagnostics to support their innovative pharmaceutical products. Healthcare providers are increasingly benefitting from personalized treatment strategies based on genomic insights, to select the right drug for the right patient at the right time and in the right dose," said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “This broad agreement gives Novartis and QIAGEN the flexibility to pursue co-development projects. We are committed working with our partners like Novartis to make improvements in life possible.”

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 leader in developing 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.

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Genome AnalysisGenomics, the study of genomes, includes functional genomics, evolutionary genomics and comparative genomics. There are many genomic technologies such as DNA sequencing of whole genomes, computational biology and bioinformatics. DNA and nucleic acids must be isolated and concentrated from cells for analysis with kits, automated analyzers and software. Other useful technologies for studying genomics include PCR, microarrays and electrophoresis.PCR and Thermal CyclingPolymerase chain reaction (PCR) kits and thermal cyclers are used for the in vitro amplification of DNA permitting subsequent analysis and experimental procedures. Explore a range of high-quality polymerase, primers and nucleotides or simplify your workflow with a PCR mastermix. Find reverse transcription PCR (RT-PCR) and cDNA synthesis kits for RNA products and libraries. 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Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Next Generation SequencingNext-generation sequencing (NGS), also known as whole-genome sequencing, high-throughput sequencing and massive parallel sequencing, produces and analyses thousands to millions of nucleotide sequences at once. 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Companion diagnostic tests are often developed in conjunction with the pharmaceutical industry.TherapeuticsTherapeutics are treatments designed to alleviate or cure diseases. These include pharmaceuticals, biologics, and gene therapies, which work by targeting specific disease mechanisms. Advances in personalized medicine and biologics offer new hope for patients with conditions that were previously difficult to treat. Browse our peer-reviewed product directory to find therapeutic solutions for various diseases; compare products, check user reviews, and get pricing directly from manufacturers.
QIAGEN Signs Ninth Master Collaboration Agreement for Companion Diagnostics