Hilden, Germany, November 28, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the QIAscreen HPV PCR Test, a CE-IVD marked molecular diagnostic test for the detection of 15 recognized high-risk genotypes of human papillomavirus (HPV), the virus considered to be the cause of cervical cancer. The assay includes both screening and genotyping functionality in one assay.
QIAscreen is based on an assay design which has proven to be highly accurate and effective as demonstrated with 100% concordance to the “Meijer Guidelines (Hesselink et al. JCM 2007).” Uniquely designed to detect a range of DNA targets within the E7 region of the HPV virus, QIAscreen provides the flexibility of PCR without the risk of false-positives due to L1 deletion which other PCR assays are subject to. Studies have shown, that assays focused on the L1 region of the virus genome “may be associated with a 2–3% false negative rate due to integration events in the L1 open reading frame” (Capone R et al. Clinical Cancer Research2000). With QIAscreen, women now have the benefit of a PCR-based test that eliminates the risk of false-negatives due to L1 related integration events. In addition to the assay design having been studied in several larger clinical studies, the clinical performance of QIAscreen itself was tested using nearly 1,600 samples from the Valgent-3 panel reporting a clinical sensitivity and specificity to CIN3+ of 97.3% and 89.0%, respectively. These results as compared to other leading PCR assays that have published sensitivity and specificity to CIN3+ of 90.0% and 60.0%, respectively, represent a best-in-class clinical profile for amplification-based assays. In addition, QIAscreen has been fully validated for self-collected samples including dry collection and lavage samples.
QIAscreen will be introduced to customers at EUROGIN 2018, the international conference for the European Research Organization on Genital Infection and Neoplasia, being held from December 2-5, 2018, in Lisbon, Portugal.
QIAscreen builds on QIAGEN’s history of providing industry-leading cervical cancer screening portfolio focused on detecion of HPV, which is considered a critical element of the strategy for prevention and treatment of this potentially deadly cancer. QIAGEN’s portfolio includes the gold-standard digene® HC2 HPV Test; the careHPV® Test, developed for use in areas with limited medical and laboratory resources; and the QIAsure Methylation Test for risk stratification. These products together represents QIAGEN’s long-standing commitment to the area of cervical cancer prevention and will continue to position QIAGEN as market leaders and innovators in this space.
The QIAscreen HPV PCR Test has been launched in Europe for use on either clinician-collected or self-collected specimens. This is an important a benefit for women and healthcare systems because self-sampling can streamline processes and avoid unnecessary further medical intervention. It includes separate identification of HPV 16 and 18, which are two high-risk genotypes of the HPV virus whose identification is considered by some physicians to be important in terms of treatment.
QIAscreen has been validated on QIAGEN’s Rotor-Gene® Q MDx system, a PCR (polymerase chain reaction) platform that is a member of the modular QIAsymphony family of automation solutions. QIAGEN also intends to offer a version of the QIAscreen HPV PCR Test for NeuMoDx’s 96 and 288 molecular systems in the future for customers who seek higher volume and fully integrated PCR-based HPV testing.
“Launching QIAscreen as a complete and efficient workflow for cervical cancer screening reaffirms our global leadership in providing solutions to help protect women from this potentially fatal disease. QIAGEN offers the world’s most comprehensive portfolio for cervical cancer screening in highly varied clinical settings,” said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “We are committed to meeting customer needs by offering innovative solutions, and this new PCR-based test provides laboratories with the ability to consolidate a range of women’s health diagnostics onto a single automation system with the Rotor-Gene® Q MDx system.”
Cervical cancer is the fourth most common cancer among women worldwide, with an estimated 528,000 new cases and 266,000 deaths in 2012, the most recent year for which WHO publishes statistics. An estimated 80% of new cases and deaths occur in developing countries, where awareness of the disease and access to preventive tests and medical treatment is low. In many low-resource areas, cervical cancer has eclipsed breast cancer as the primary cancer killer of women.
QIAscreen HPV PCR Test
The QIAscreen HPV PCR Test is an in vitro real-time PCR-based assay for the qualitative detection of human papillomavirus (HPV) DNA of 15 presumed high-risk HPV genotypes. Validated sample types include cervical specimens collected in PreservCyt, Pathtezt and Surepath collection medium, as well as self-collected vaginal brush specimens collected and shipped dry or in saline or self-collected cervico-vaginal lavage specimens. For more information, visit https://herQIAGEN.com/QIAscreen.
QIAGEN collaborated with Self-screen BV, a biotech spinoff company of VU University Medical Center in Amsterdam, in developing this test. Self-screen is the Legal Manufacturer of the QIAscreen HPV PCR Test. “We are pleased to partner with QIAGEN again to bring another innovative HPV diagnostic application to the market. QIAscreen and QIAsure together will give clinicians the ability to provide women all the critical information necessary to make the best-informed decision for their clinical management,” said Prof. Dr. Chris Meijer, Chief Executive Officer of Self-screen.
QIAGEN’s leadership in cervical cancer testing
The QIAscreen HPV PCR Test adds to QIAGEN’s portfolio of diagnostic tools for use in women’s health and fills out the industry’s most comprehensive offering for cervical cancer screening. Other solutions:
- The first-in-class 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 nearly 20 years of clinical practice and more than 100 million tests worldwide.
- The careHPV Test for use in low-resource areas, recently added to the World Health Organization (WHO) list of prequalified in vitro diagnostics, makes the same highly validated HPV testing technology available for every woman.
- The QIAsure Methylation Test provides additional insights for differentiating patients’ risk of developing cervical cancer to aid decision-making on treatments and reduce unnecessary harm.
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 September 30, 2018, QIAGEN employed approximately 4,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Certain of the statements contained in this news 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, markets, strategy or operating results, including without limitation its expected operating 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 in applied testing, personalized healthcare, clinical research, proteomics, women’s health/HPV testing and nucleic acid-based 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, the consummation of acquisitions, 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).