QIAGEN launches QIAsure Methylation Test to determine cervical cancer risk
Jun 14 2016

QIAGEN launches QIAsure Methylation Test to determine cervical cancer risk

New follow-up assay helps stratify patients with transforming HPV infections

Hilden, Germany, and Salzburg, Austria, June 14, 2016 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the QIAsure Methylation Test, a novel CE-marked molecular diagnostic test for use in differentiating patients’ risk of developing cervical cancer.

The QIAsure Methylation Test is highly complementary to HPV screening tests and follows either a positive high risk HPV test or a finding of abnormal cells in cytology from a Pap smear and can be used on either clinician collected or self-collected samples. Currently available triage options such as HPV genotyping or tissue-based assays often have limited clinical value, or are subjective and in many cases lead to false positives or missed cervical disease. QIAsure testing accurately stratifies cervical cancer risk by detecting and measuring DNA methylation of two specific genes implicated in cervical cancer. In large scale studies, the DNA markers used in this assay have demonstrated reliable additional insights into a patient’s individual risk and contributed to decisions on surveillance and treatment. The test is being presented to the public for the first time at EUROGIN 2016, the international conference for the European Research Organization on Genital Infection and Neoplasia, in Salzburg, Austria.

“QIAsure is a highly attractive and complementary addition to our leading HPV franchise”, said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “It creates a compelling solution for primary screening that includes the leading HPV primary screening test and leading solution for automated sample processing and molecular analysis of cervical samples.“

“The QIAsure Methylation Test is an important advance for women’s health. When a woman screens positive for HPV, or cytology shows abnormal cells, she is at risk of developing cervical cancer. The QIAsure test is the next logical step to assess this risk,” said Dr. Tadd Lazarus, Chief Medical Officer of QIAGEN. “This highly sensitive, specific molecular test identifies cancer specific epigenetic changes in cervical cells and enables the physician to assess whether the HPV infection is progressing toward cancer – a valuable insight that provides timely reassurance and guidance to treatment for each individual patient.”


Medical need in cervical cancer detection

Globally, cervical cancer affects approximately over 500,000 women annually and is the third-most-common malignancy in women after breast and colon cancer. Cervical cancer is caused by the human papillomavirus (HPV), and women can be screened for HPV – making the cancer highly preventable and treatable. The virus, however, is a common infection and in most cases HPV-infected cervical cells do not transform into cervical cancer.

HPV testing is generally accepted as being more sensitive but less specific than cytology for detecting cervical disease. However, the benefit of increased disease detection using HPV as a primary test also results in many positive HPV tests in patients without underlying cervical disease. A positive HPV test result calls for follow-up testing to differentiate each patient’s risk based on cellular effects of the infection. With increased interest and uptake of HPV testing as a primary test, the need for a suitable triage test following a positive HPV test is increasing.

The currently favored triage method for a positive HPV result is cytology. Cytology lacks sensitivity, is subjective, and skill dependent. As primary HPV testing and vaccination prevention methods are implemented, the number of patients with abnormal cells will decrease, and consequently cytology will be increasingly harder to perform. In some countries the lack of cytology infrastructure required for necessary triage is a barrier to adopting primary HPV screening. This makes a complete molecular solution highly desirable. And so the need for an accurate molecular test following a HPV-positive test result is clearly an unmet medical need.


QIAsure Methylation Test

The CE-IVD marked QIAsure Methylation Test is launching in Europe, Middle East and Africa for use on either clinician-collected or self-collected specimens, a benefit for women and healthcare systems because self-sampling can streamline processes and avoid unnecessary further medical intervention. The test has been validated on the Rotor-Gene® Q MDx system, a PCR platform that is a member of the modular QIAsymphony family of automation solution.

QIAGEN collaborated with Self-screen BV, a biotech spinoff company of VU University Medical Center in Amsterdam, in developing this test. “We are pleased to partner with QIAGEN to make this new triage test available. The launch is a milestone for Self-screen, which has developed and validated innovative multiplex assay technologies based on the work of our scientists at VU University Medical Center. More importantly, the test is an improvement for women’s health, offering reliable risk stratification as a follow-up to HPV screening or cytology,” said Prof. Dr. Chris Meijer, Chief Executive Officer of Self-screen.

The QIAsure Methylation Test helps assess transforming HPV infections from non-threatening ones by detecting molecular changes known as methylation in promoter regions of host cell FAM19A4 and mir124-2 genes, which are hyper-methylated in cervical cancers. Current triage options are not ideal in stratifying risk: Genotyping of HPV16/18 lacks specificity, leading to false positive results; cytology lacks sensitivity, leading to missed cervical disease. By identifying hyper-methylation of these host cell genes, the QIAsure test provides highly sensitive and specific results for patients and clinicians.

QIAsure will be available in Europe in the later course of 2016.


About QIAGEN’s leadership in HPV testing

QIAGEN is the global leader in providing highly reliable molecular tests for HPV screening, including the digene® HC2 HPV Test and the careHPV® Test for areas with limited resources. The new QIAsure Methylation Test perfectly adds to QIAGEN’s portfolio of diagnostic tools for use in women’s health and leverages the Company’s leading position in primary screening.

QIAGEN’s digene® HC2 HPV Test, the Gold Standard for sensitive, early detection of high-risk HPV, has been evaluated in clinical trials involving more than 1 million women – and proven through 15 years of clinical practice and more than 90 million tests worldwide. The digene HPV test uses advanced Hybrid Capture 2 technology to directly detect the presence of 18 types of HPV and is the only HPV assay that examines the entire length of the genome, which helps prevent false negatives caused by gene deletions that occur naturally during a woman’s biological integration of the HPV virus. When the digene HPV Test rules out high-risk HPV, the result is highly reliable, based on the higher sensitivity of the HC2 technology. This benefit is seen to be of critical value in screening settings, in particular as intervals between screenings are extended as well as in primary screening settings. QIAGEN was the first company to implement large primary screening programs and has shown unrivalled validation and performance in doing so.

The launch of QIAsure confirms QIAGEN’s commitment to market and technology leadership in the cervical cancer detection arena.


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 March 31, 2016, QIAGEN employed approximately 4,600 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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