QIAGEN launches CE-IVD assay to detect Trichomonas vaginalis in both female and male patients on the QIAsymphony RGQ platform

Germantown, Maryland, and Hilden, Germany, March 5th, 2018 – QIAGEN today announced the European launch of the artus T. vaginalis QS-RGQ Kit, a CE-marked molecular diagnostic test for the qualitative detection of the protozoan parasite T. vaginalisin both female and male patients. The artus T. vaginalis QS-RGQ Kit is an in vitro real-time polymerase chain reaction (PCR) assay for detection of T. vaginalis DNA purified from clinician-collected vaginal swabs, endocervical swabs, and urine samples from symptomatic and asymptomatic patients. This diagnostic test is configured for use with the QIAsymphony SP/AS and Rotor-Gene Q instruments (QIAsymphony RGQ) and adds to QIAGEN’s leading Sexual And Reproductive Health menu.

“The addition of the artus T. vaginalis QS-RGQ Kit to the QIAsymphony RGQ portfolio reinforces QIAGEN’s commitment to helping labs provide a comprehensive suite of solutions to meet a range of clinical needs,” said Michael Nugent, Vice President, Head of Infection and Immune Diagnostics, at QIAGEN. “This molecular test offers timely and sensitive detection of T. vaginalis in a wide range of sample types from both male and female patients.”

T. vaginalis is the most common, curable STI worldwide with 170 – 190 million new cases each year (1). The high worldwide prevalence of T. vaginalis infection and its coinfection with other STIs make Trichomoniasis a compelling public health concern. Trichomoniasis is associated with adverse pregnancy outcomes, infertility, postoperative infections, cervical neoplasia, and an increased probability of transmission of human immunodeficiency virus (HIV) (3, 4). Trichomoniasis is thought to be widely under diagnosed due to various factors, including a lack of routine testing and the low sensitivity of the commonly used diagnostic technique of wet mount microscopy. Traditional, culture-based diagnostic techniques for T. vaginalis are ill-suited for routine screening, as they are slow, difficult and offer inferior sensitivity (50 – 80%) to molecular assays (5). In addition, nonspecific symptomatology and asymptomatic cases present an issue for detection since only about 30% of those infected develop symptoms of Trichomoniasis (2).

QIAsymphony RGQ Menu Expansion

The artus T. vaginalis QS-RGQ Kit extends the STI detection capabilities of QIAsymphony RGQ and adds to the platform’s menu, the largest PCR portfolio in Europe. The QIAsymphony family of instruments features 30 different CE-IVD marked tests, including key market differentiating assays for pathogens important in transplant settings (BKV, CMV, EBV, VZV) as well as bloodborne viruses (HIV-1, HCV and HBV). This extensive menu allows customers to consolidate testing onto a Sample to Insight automation platform, saving costs and streamlining workflows. Additional flexibility is offered via open channels for user-developed tests.

QIAsymphony is an innovative, cost-effective, modular system that integrates a laboratory’s PCR workflow from initial biological sample processing to final insights. In 2017, QIAGEN celebrated surpassing 2,000 cumulative placements of QIAsymphony, demonstrating the value that customers continue to place on this powerful, highly flexible yet easy-to-use system. Three modules make up the complete system: QIAsymphony SP for efficient sample processing, with continuous loading and gold standard protocols to process and purify samples; QIAsymphony AS, enabling safe and reproducible assay setup with multiple assays per run or sample; and Rotor-Gene Q, the world’s first rotary real-time PCR cycler system, to make DNA and RNA sequences visible and quantifiable. QIAsymphony integrates with bioinformatics software for analysis and interpretation, as well as with Laboratory Information Management Systems.

QIAGEN’s Leadership In Sexual and Reproductive Health

The artus T. vaginalis QS-RGQ Kit complements QIAGEN leading suite of molecular tests for Reproductive Health screening, which includes an assay for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) detection, the digene^® HC2^® HPV DNA Test, the careHPV^® Test, the QIAsure™ Methylation Test, and the AmniSure^® ROM Test.

QIAGEN’s digene HC2 HPV DNA Test, the gold standard for sensitive early detection of high-risk HPV, has been proven though 15 plus years in clinical practice, and millions of tests performed worldwide. The careHPV^® Test has demonstrated the ability to reach women in areas of limited resources, providing a sensitive cervical cancer screening tool to underserved populations. The introduction of the QIAsure Methylation Test has the potential to revolutionize cervical cancer screening by giving physicians more information, which may allow them to make the best management decisions for their patients. QIAGEN also offers  the AmniSure^® ROM Test, the only test for rupture of membranes (ROM) with published data to show correlation to the goal standard, Indigo Carmine, showing  99% accuracy.

To learn more about the artus T. vaginalis QS-RGQ Kit, visit www.qiagen.com/cmp/mdx/tvaginalis

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, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected sales, adjusted net sales and adjusted diluted earnings per share 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; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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).

References

1. WHO. Global incidence and prevalence of selected curable sexually transmitted infections – 2008, WHO 2012.
2. Centers for Disease Control and Prevention. (2017). Retrieved from https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm
3.  Soper, D. (2004). Trichomoniasis: under control or undercontrolled? Am. J. Obstet. Gynecol. 190, 281.
4. Forna, F. and Gülmezoglu, A.M. (2003). Interventions for treating trichomoniasis in women. Cochrane Database Syst. Rev. CD000218.
5. Caliendo, A. M. et al., (2005) Real-time PCR improves detection of Trichomonas vaginalis infection compared with culture using self-collected vaginal swabs. Infectious Diseases in Obstetrics and Gynecology, 13(3): 145–150.