QIAGEN expands liquid biopsy pipeline with AR-V7 test in prostate cancer
Mar 31 2017

QIAGEN expands liquid biopsy pipeline with AR-V7 test in prostate cancer

Exclusive license to RNA biomarker from The Johns Hopkins University clears path to commercialization

Hilden, Germany, and Germantown, Maryland, March 31, 2017 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it is commercializing the Research use only AdnaTest Prostate Cancer Panel AR-V7 to detect the androgen receptor splice variant 7 (AR-V7) from liquid biopsies to investigate resistance to potential drugs for advanced prostate cancer. QIAGEN has acquired an exclusive worldwide license from Johns Hopkins University for detecting the AR-V7 biomarker in all sample and cell types through nucleic acid tests such as polymerase chain reaction (PCR) or next-generation sequencing (NGS). Johns Hopkins researchers have used AdnaTest technology in studies to evaluate the expression of AR-V7 messenger RNA in prostate cancer patients.

“Our AdnaTest workflow unlocks an important biomarker for clinical research to provide for the development of prostate cancer diagnostics in the future. Providing accurate insights from circulating tumor cells in a blood sample, our AR-V7 solution is a significant addition to our portfolio of non-invasive liquid biopsies for Personalized Healthcare,” said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “We are pleased to partner with the pioneering researchers at Johns Hopkins in developing this workflow. We plan to make the AdnaTest kit commercially available this year, as a Sample to Insight solution for clinical researchers.”

Johns Hopkins researchers highlighted the role of AR-V7 variants in understanding response in patients with castration-resistant prostate cancer (CRPC) in a 2014 article in the New England Journal of Medicine. In the study, scientists used AdnaTest workflows for isolation, enrichment and detection of the AR-V7 marker from circulating tumor cells in blood samples using reverse-transcription polymerase chain reaction (RT-PCR).

In 2015 QIAGEN acquired the AdnaTest technology for detecting RNA expression from circulating tumor cells (CTCs) obtained from blood samples as non-invasive liquid biopsies. QIAGEN is currently working with several pharmaceutical companies to field-test the assay for clinical research in prostate cancer. The agreement with Johns Hopkins provides QIAGEN the exclusive worldwide license for detection of the AR-V7 marker.

Prostate cancer is the second most common cancer in men, according to the World Health Organization (WHO). About 1.1 million were diagnosed with prostate cancer worldwide, with an estimated 307,000 deaths, in 2012, the most recent year for which statistics are available. In the United States, the American Cancer Society estimates more than 160,000 men will be diagnosed with prostate cancer in 2017, resulting in more than 26,000 deaths. About one in seven men in the U.S. will be diagnosed with prostate cancer during his lifetime, and it is the third leading cause of cancer deaths for American men.

QIAGEN is a global leader in developing Sample to Insight workflows for non-invasive liquid biopsies in oncology, prenatal testing and other applications. QIAGEN is actively partnering with pharmaceutical and biotech companies to develop companion diagnostics using liquid biopsies and PCR or NGS analysis of biomarkers for stratification or monitoring of patients. In 2015, QIAGEN introduced the first regulated companion diagnostic assay based on molecular biomarkers from circulating tumor DNA. QIAGEN also has collaborations underway using circulating tumor cells and exosomes collected from blood or plasma. Liquid biopsies are easier to perform, less risky and less expensive than tissue biopsies, and they can be repeated at regular intervals for monitoring of disease progression.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of December 31, 2016, QIAGEN employed approximately 4,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

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