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QIAGEN Announces Companion Diagnostics Program

QIAGEN
22 Nov 2013
Sonia Nicholas
Managing Editor and Clinical Lead

Industry news

QIAGEN has announced an agreement with Eli Lilly and Company to develop and commercialize a molecular companion diagnostic paired with a novel Lilly oncology compound. This is the third co-development project by QIAGEN and Lilly to create companion diagnostics, which are tests that analyze genomic information in patient samples to enable personalized decisions on treatments.

The latest collaboration, involving an undisclosed Lilly compound and an undisclosed molecular diagnostic target, builds on a master collaboration agreement for development of tailored therapies in cancer and other therapeutic areas signed earlier this year.

QIAGEN and Lilly are long-standing partners in personalized healthcare. QIAGEN’s therascreen® KRAS RGQ PCR Kit has been widely adopted by laboratories since its July 2012 approval by the Food and Drug Administration (FDA) as a companion diagnostic. The therascreen KRAS Test detects gene mutations in metastatic colorectal cancer patients, indicating which ones will benefit from Erbitux. In September 2011, QIAGEN and Lilly partnered to develop a companion diagnostic that evaluates the Janus kinase 2 (JAK2) gene, which plays a role in some blood cancers. The test is paired with a Lilly compound to guide use of the proposed drug, currently in clinical trials.

"We are pleased to partner with Lilly on a third development program to improve life for cancer patients through companion diagnostics that guide the use of novel targeted medications. QIAGEN is a preferred partner for leading pharmaceutical companies like Lilly because our validated development processes and regulatory track record provide an accelerated path to commercialization,” said Peer Schatz, QIAGEN’s Chief Executive Officer. “Using standardized, well-validated processes to develop and commercialize companion diagnostics reduces the risks in drug development for Pharma companies. Once approved, our therascreen tests have a ready path to commercial adoption since laboratories around the world have embraced QIAGEN’s efficient QIAsymphony automation platform."

"Partnering with QIAGEN on this program enables Lilly to continue to advance our goal of providing tailored therapies to patients in need," said Daniel Skovronsky, M.D., Ph.D., vice president, tailored therapeutics, Lilly and CEO, Avid Radiopharmaceuticals, Lilly’s wholly owned molecular imaging subsidiary. “The QIAGEN and Lilly teams have formed strong working relationships and we look forward to working with QIAGEN to advance this latest innovation together.”

The Lilly co-development program and others are designing companion diagnostics that offer laboratories an efficient workflow on QIAGEN’s Rotor-Gene Q MDx instrument using real-time PCR technology. The Rotor-Gene Q MDx is part of the QIAsymphony family of automated platforms.

In addition to the Lilly collaboration, QIAGEN is a leading partner globally in developing and validating companion diagnostics to transform patient care and extend lives by providing personalized genomic information to guide treatment decisions in cancer and other diseases. More than 15 projects with pharmaceutical and biotech companies are underway to create new companion diagnostics. In addition to the FDA-approved therascreen KRAS test, QIAGEN received FDA approval in July 2013 for the therascreen® EGFR RGQ PCR Kit as a companion diagnostic for a new targeted therapy in metastatic NSCLC patients whose tumors have certain gene mutations. Globally, QIAGEN offers the broadest portfolio of companion diagnostics, including the therascreen EGFR and KRAS kits in Japan, and more than 15 CE-marked assays for personalized healthcare applications in Europe.

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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.Medicinal ChemistryMedicinal chemistry is a broad discipline encompassing the design, identification, synthesis and development of chemicals in drug discovery. It includes a number of techniques covering structural biology, synthetic chemistry and molecular biology. Technologies used in medicinal chemistry include ADME, lab-on-a-chip, high content screening and assay assembly.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.Gene Expression and Molecular CloningMolecular cloning is a set of techniques that utilizes vectors to transfer recombinant DNA into host cells and is an essential tool for investigating the expression of genes and proteins in bacterial or mammalian cells. A variety of vectors optimized for gene cloning and expression in a range of host organisms are available, alongside competent cells for genetic replication. Here, you can explore a range of molecular tools, high-quality genomic and cDNA libraries, premade clones, transformation and transfection reagents and mutagenesis or gene expression detection assays and expression arrays. Find the best gene expression and molecular cloning products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.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.Companion DiagnosticsCompanion diagnostics are tests, often <i>in vitro</i>, that are used to determine whether a therapeutic product will be safe and effective for use on an individual. They also identify which patients will benefit most from them. Companion diagnostic tests are often developed in conjunction with the pharmaceutical industry.Precision MedicinePrecision medicine refers to the idea of customized healthcare, where medical decisions and treatments are tailored to the individual patient. Molecular diagnostics, companion diagnostics and Next Generation Sequencing (NGS) play a pivotal role in this approach.

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