U.S. FDA premarket approval for QIAGEN’s automated artus® CMV QS-RGQ MDx kit for use on its QIAsymphony platform

High-throughput application of artus CMV QS-RGQ MDx Kit on QIAsymphony streamlines critical and frequently performed viral infection test for transplant patients

Germantown, Maryland, and Hilden, Germany, 07-Jun-2017 — /EuropaWire/ — QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received premarket approval from the U.S. Food and Drug Administration (FDA) for its automated artus^® CMV QS-RGQ MDx kit for use on QIAGEN’s QIAsymphony platform, providing fast, reproducible, high-quality test results for use as an aid in the management of solid organ transplant patients who are undergoing anti-CMV therapy.

Patients who have undergone organ transplantation have an elevated risk of infection from CMV, which is a common virus that infects people of all ages. Over half of all adults by age 40 have been infected with CMV, according to the U.S. Centers for Disease Control (CDC). Once CMV is in a person’s body, it stays there for life in latent form and can reactivate.

Among organ transplant patients, an estimated 40-70% of post-transplant mortality is linked to higher susceptibility to opportunistic infections such as CMV. Timely and accurate monitoring of CMV viral load through a molecular test such as the artus CMV assay is essential to monitoring these patients, and in particular for those undergoing antiviral drug therapy for a CMV infection. The U.S. market for annual CMV testing is estimated at about 1.1 million tests, and QIAGEN is a leader in transplant-related molecular testing on a global scale and supported by a strong market presence in the U.S.

“QIAGEN is a leader in supporting clinical laboratories and physicians in the care of transplant patients with our unique portfolio of artus assays for molecular screening as well as the QuantiFERON portfolio of assays for assessment of a patient’s immune status. This application of our artus CMV kit on the QIAsymphony automation system will be an important catalyst to strengthen this comprehensive portfolio,” said Thierry Bernard, Senior Vice President, Molecular Diagnostics Business Area at QIAGEN. “This kit will allow QIAGEN to serve a new group of higher-volume CMV test customers, while providing our dedicated QIAsymphony base of customers a new test that will help them handle growing CMV test volumes. This marks the seventh FDA-cleared or approved QIAGEN test based on PCR technology, and strengthens the position of QIAsymphony as a versatile and high-performance molecular testing platform.”

The CMV kit, which processes human plasma samples (EDTA tube collection), is a migration of the FDA-approved artus^®CMV RGQ MDx Kit to the QIAsymphony platform and offers many benefits in the management of solid organ transplant patients undergoing anti-CMV therapy:

• Greater ease of use and flexibility since clinical laboratories with higher sample volumes will benefit from faster, higher-throughput processing with the QIAsymphony workflow, while lower-volume labs that send out all or part of current CMV testing now have an opportunity to bring CMV and transplant testing into their own laboratories in a cost-efficient and scalable manner.  QIAsymphony is an industry-leading molecular testing automation platform, and appreciated by customers for features that include the ability to automate laboratory-developed tests (LDTs).

• Proven clinical performance and standardization since the artus CMV QS-RGQ MDx kit is standardized to the World Health Organization (WHO) standard, and results are reported in IU/ml as recommended by international consensus guidelines for CMV management in solid organ transplant patients.1,2

• Advances in market-leading transplant assay portfolio, with the new artus CMV QS-RGQ MDx kit as the latest addition to QIAGEN’s portfolio in the United States. In Europe, QIAGEN offers CE-IVD marked artus assays for the detection of numerous transplant-associated pathogens including CMV, EBV, BKV, HSV-1/2, VZV, JCV, HAdV and HHV6 on its QIAsymphony and Rotor-Gene platforms. These assays complement QIAGEN’s comprehensive range of CE-IVD marked immune monitoring solutions in transplant based on the proprietary QuantiFERON technology –  QuantiFERON®-CMV and QuantiFERON Monitor® provide the most complete picture of transplant-patient immune status available from a single-source provider.

¹ Kotton CN, Kumar D, Caliendo AM, et al. International consensus guidelines on the management of cytomegalovirus in solid organ transplantation. Transplantation 2010; 89: 779.

² Kotton CN, Kumar D, Caliendo AM, et al. Updated international consensus guidelines on the management of cytomegalovirus in solid-organ transplantation. Transplantation 2013; 96(4):333.

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, 2017, QIAGEN employed approximately 4,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

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). 

SOURCE: QIAGEN

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