Lilly and QIAGEN and Companion Diagnostics


Companion diagnostics unlock a patient’s molecular information in order to guide treatment decisions for specific cancers or other diseases.


On February 13th it was announced that Eli Lilly and QIAGEN entered into a master collaboration agreement for the development and commercialization of companion 1) ___ for pairing with Lilly investigational and approved medicines across all therapeutic areas. The agreement provides a framework for Lilly and QIAGEN to collaborate on future projects across all of Lilly’s therapeutic areas with the goal of bringing to market Lilly 2) ___ paired with QIAGEN diagnostics. It also further underscores QIAGEN’s leading position in partnering with global pharmaceutical companies to deliver the benefits of personalized medicine to patients and healthcare providers.


“Tailored therapies are a key component of Lilly’s strategy of providing improved outcomes for individual 3) ___. By working with partners like QIAGEN, we are advancing a number of tailored therapeutics in an effort to target the right medicine to the right patient,“ said Daniel Skovronsky, M.D., Ph.D., vice president, tailored therapeutics, Lilly, and chief executive officer, Avid Radiopharmaceuticals, which is a wholly-owned subsidiary of Lilly. This agreement lays the groundwork for potential future projects with Lilly in various therapeutic areas and enables significant efficiencies for future development programs by 4) ___ interfaces and processes between the organizations. Through partnerships like this, QIAGEN offers pharma companies a cost-effective way to maximize the value and benefits of potential new medicines in their pipelines, while also reducing the risks in medicine development.


QIAGEN is at the forefront globally in developing and validating Personalized Healthcare tests that provide physicians with 5) ___ information on each patient to guide the selection of medicines in treating cancer and other diseases. QIAGEN is actively expanding its pipeline of tests for important biomarkers and intends to submit several companion diagnostics for U.S. regulatory approval. Last month, QIAGEN announced submission of its therascreen® EGFR RGQ PCR Kit test to the FDA as a proposed companion diagnostic to guide treatment with a new investigational oncology compound developed by Boehringer Ingelheim.


QIAGEN and Lilly have previously collaborated on companion diagnostics designed to run on QIAGEN’s Rotor-Gene Q system, a component of the QIA symphony family of automated instruments, which is revolutionizing 6) ___ workflows. QIAGEN’s strategy is to develop FDA-approved diagnostics in the United States for use on this platform.


QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from 7) ___ samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation.


Last year, Qiagen’s KRAS RGQ PCR helped Lilly and partner Bristol-Myers Squibb nail down an expanded indication for 8) ___ drug Erbitux. Now, Lilly is employing the company to collaborate on treatments across all its therapeutic areas, a deep dive into companion diagnostics and personalized medicine for the drugmaker. The big Erbitux approval seems to have galvanized Lilly’s commitment to companion diagnostics, as the Qiagen deal follows a similar one last month when Lilly signed on with Agilent’s Dako diagnostics unit to develop assays for its oncology pipeline. Before that, the Lilly partnered with 2012 Fierce 15 winner PrimeraDx to use that company’s ICEPlex assay-development platform.


Big Pharma’s big buy-in to companion diagnostics is unlikely to shrink, as more and more blockbuster hopefuls are being developed with matching assays designed to sway regulators, payers and patients. Roche leads the pack, with CEO Severin Schwan saying 60% of the company’s pipeline treatments will be packaged with complementary 9) ___. And fellow heavyweights Pfizer, AstraZeneca and BMS have all reached out to diagnostics companies to help target their treatments.


Qiagen’s KRAS RGQ PCR Kit


The FDA approved the KRAS RGQ PCR Kit the same day it approved an expanded indication for Erbitux and analysts hailed the pairing as a victory for 10) ___ medicine. Erbitux was already approved for head and neck cancer, but with Qiagen’s assay identifying the colorectal cancer patients who would respond to the therapy, BMS and Lilly were able to persuade the FDA. The test IDs patients with so-called “wild-type“ KRAS genes, about 60% of whom benefit from Erbitux, according to Qiagen. Weeding out patients who won’t respond to the drug could save about $600 million a year in the U.S., the company says, and that’s music to the ears of payers.


While the Erbitux-KRAS test combo stood out in 2012, many in the life sciences world say the blockbusters of the future will come hand-in-hand with companion diagnostics. “Twenty years ago, the paradigm was that for every 100 cancer patients treated, 10 benefited,“ UBS analyst Gbola Amusa told the Financial Times. “If you could instead only treat those 10 patients, you get the same result without putting through 90 who don’t benefit, and society gains. Ten years from now, this will be standard.“


ANSWERS: 1) diagnostics; 2) medicines; 3) patients; 4) standardizing; 5) genomic; 6) laboratory; 7) biological; 8) cancer; 9) tests; 10) personalized


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