QIAGEN launches AdnaTest liquid biopsy kits in prostate and lung cancer

Germantown, Maryland, and Hilden, Germany, April 12, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today launched two novel liquid biopsy panels to evaluate circulating tumor cells (CTCs) in the growing field of research into molecular mechanisms in prostate and lung cancers. The AdnaTest ProstateCancerPanel AR-V7 Kit and AdnaTest LungCancer Kit will be introduced at the American Association for Cancer Research (AACR) 2018 Annual Meeting from April 14-18 in Chicago.

Also at the AACR conference, more than 40 scientific abstracts are highlighting studies relying on applications of a broad range of QIAGEN’s Sample to Insight solutions – differentiated sample technologies, tools for analysis on platforms for next-generation sequencing (NGS) and polymerase chain reaction (PCR), and bioinformatics solutions to deliver actionable insights from molecular testing.

“We are excited to collaborate with the cancer research community at AACR 2018 in driving innovative science to fulfill the hope of improving patient care. Our AdnaTest liquid biopsy-based portfolio now offers molecular characterization in leading cancers with insights into tumor biology, pathways, relevant biomarkers, cancer progression and even resistance to therapy,” said Dr. Thomas Schweins, Senior Vice President and head of QIAGEN’s Life Sciences Business Area. “Abstracts being presented at AACR feature dozens of novel solutions from our Sample to Insight portfolio for discovery research and clinical development, with promise for transforming the future of cancer care.”

AdnaTest ProstateCancerPanel AR-V7 Kit

The new AdnaTests build on QIAGEN’s proprietary AdnaTest Combination of Combinations Principle technology, a highly specific immunomagnetic cell-selection system for enriching circulating tumor cells (CTCs) from peripheral blood that allows sensitive analysis of cancer-associated gene expression.

The novel AdnaTest ProstateCancerPanel AR-V7 Kit provides new insights into tumor biology by detecting the androgen receptor splice variant 7 in CTCs of prostate tumor origin isolated from blood samples to investigate potential resistance to drugs for advanced prostate cancer. With an exclusive worldwide license from Johns Hopkins University for nucleic acid detection of the AR-V7 biomarker for diagnostic use, QIAGEN is now launching the test for research use. Johns Hopkins researchers first highlighted the potential clinical relevance of AR-V7 in a 2014 article in the New England Journal of Medicine. In the study, they used AdnaTest workflows for isolation, enrichment and detection of the AR-V7 marker from CTCs in blood samples using reverse-transcription polymerase chain reaction (RT-PCR).

Prostate cancer is the second most common cancer in men, with about 1.1 million diagnosed worldwide and an estimated 307,000 deaths in 2012, the most recent year for which global statistics are available, according to the World Health Organization (WHO). About one in nine men in the United States will be diagnosed with prostate cancer during his lifetime, and it is the second leading cause of cancer deaths for American men, according to the American Cancer Society’s 2018 estimates.

AdnaTest LungCancer Kit

The new AdnaTest LungCancer Kit delivers unique insights into the molecular mechanisms of lung cancer through highly specific selection of CTCs, including stem cell-like cells implicated in cancer growth and epithelial-mesenchymaltransition (EMT), an important marker of resistance to cancer therapy. A proprietary set of antibodies provides sensitive detection of lung cancer-associated targets through reverse-transcriptase PCR. The open system ensures flexibility for users to add the targets of interest.

Lung cancer is the world’s most common cancer and the leading cause of death from cancer. About 1.8 million people were diagnosed with lung cancer and 1.59 million died in 2012, the most recent year for which statistics are available, according to the World Health Organization (WHO). In the United States, lung and bronchus cancer is the second most common cancer but by far the most deadly, with an estimated 154,000 deaths expected in 2018, according to the American Cancer Society.

“The ability to analyze circulating tumor cells offers potential to expand our understanding of the molecular mechanisms of lung and prostate cancer and advance new approaches to treatment. With the high specificity and sensitivity of the AdnaTest kits, researchers can use liquid biopsies to achieve reliable, accurate characterization of lung and prostate cancer CTCs for interpretation of disease development and metastasis,” said Michael Kazinski, Senior Director and head of Sample Technologies at QIAGEN.

QIAGEN Presence at AACR 2018

Among the scientific presentations at AACR 2018, 42 abstracts highlight research utilizing QIAGEN’s broad portfolio of Sample to Insight solutions. More than a third of those studies use QIAGEN solutions for liquid biopsies to unlock molecular insights. Five abstracts focus on applications of the GeneReader NGS System in clinical research on various cancers, while five others utilize QIAGEN’s universal solutions for next-generation sequencing. Several studies deployed QIAGEN bioinformatics solutions to investigate challenges in cancer care, and others used PCR and Pyrosequencing solutions in cancer applications.

Exhibition booth No. 3431 at the AACR conference will feature demonstrations of a range of QIAGEN’s Sample to Insight solutions. To learn more about QIAGEN’s presence at AACR, please visit https://aacr2018.qiagen.com/ or follow the Twitter handle @QIAGEN during the conference.

QIAGEN will host an AACR exhibitor spotlight presentation, “Unlocking cancer’s secrets: from measuring residual disease in AML to using advanced bioinformatics to explore disease signatures in CLL,” presented by Dr. Christopher S. Hourigan of the National Heart, Lung, and Blood Institute (NHLBI) and Dr. Jean-Noel Billaud of QIAGEN Bioinformatics, at 12:30 p.m. Tuesday April 17 in Spotlight Theater B.

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 (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of December 31, 2017, 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).