HILDEN, Germany, and GERMANTOWN, Maryland, January 27, 2015 /PRNewswire/ --
- QuantiFERON Monitor (QFM®) launches in Europe for monitoring immune function
- Target markets include transplant patients and research in managing immune modulation and suppression
- Novel diagnostic with significant potential to expand clinical utility and to address unmet medical need in more than 100,000 solid organ transplants a year
- QFM applies proven QuantiFERON technology to deliver standardized, cost-effective measurement of immune function
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the commercial launch of QuantiFERON Monitor® (QFM®), a novel diagnostic for monitoring immune function. QIAGEN is launching QuantiFERON Monitor in Europe as a CE-marked in-vitro diagnostic. Primary applications include monitoring of immune function in solid organ transplant recipients. In North America and other markets, QFM is available for research use as an accurate marker of immune function in studies of immunosuppressive conditions, immune modulating therapies and recovery following transplantation. More than 100,000 patients a year worldwide undergo solid organ transplant surgery.
QFM measures the cell-mediated immune response and can provide important information on the strength of the immune system in the immunosuppressed solid organ transplant population. The test thereby targets an important medical need of physicians who need to assess patients' risk for both organ rejection and infections in order to determine the right dosage of immunosuppressive drugs. Currently, best practice in assessing immune reactivity is to monitor levels of those drugs. However, today there are no standard drug regimens applied to all patients. As an estimated 40-70% of deaths following transplant surgery are attributable to issues with immunosuppression or immunosuppressants, the Food and Drug Administration (FDA) has recommended that drug levels alone should not be used to adjust drug dosing.
QuantiFERON Monitor addresses this critical unmet medical need with a range of novel characteristics that hold promise for clinicians and researchers:
- QFM uses a combination of stimulants that specifically target different cell types involved in both the innate and adaptive immune systems to detect cell-mediated immune response, thereby providing qualitative and quantitative measurement of cell-mediated immune function. Clinical studies are underway to investigate QFM's utility in transplantation for multiple organs (heart, lung, liver and kidney).
- QuantiFERON Monitor has the potential to allow clinicians to guide preventive treatment decisions by accurately predicting the risks for organ rejection and infections - and to reduce the dosing of costly and potentially toxic drugs during recovery.
- QFM leverages QuantiFERON technology - demonstrated in global use with QIAGEN's QuantiFERON-TB® Gold, QuantiFERON-TB® Gold Plus and QuantiFERON-CMV® - to support standardized, rapid and cost-effective testing. QuantiFERON Monitor applies this robust technology to monitoring the immune system and complements QIAGEN's leading transplant portfolio.
- QuantiFERON Monitor holds potential for application in monitoring immune response for other conditions, including inflammatory bowel disease, HIV, cancer and immunotherapy. QIAGEN expects research in these fields to further explore the clinical utility of QFM.
"We are very pleased to add QuantiFERON Monitor to our portfolio of diagnostic tools for transplant care and to expand our line of highly accurate tests using QuantiFERON technology. We believe QFM has the potential to address a large unmet medical need among the 100,000 organ transplant patients a year," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "We look forward to making QuantiFERON Monitor widely available for clinical use - and encourage researchers to further establish its clinical utility. We expect this novel test, with accurate and cost-effective monitoring of the key cells in the body's immune response, to provide a highly valuable tool for the management of immunosuppressed patients."
According to Dr. Deepali Kumar, Associate Professor of Medicine and Transplant Infectious Diseases at the University of Toronto, an immune monitoring strategy that can accurately predict the risk of developing infection after transplant would be an important advance in the care of transplant recipients. "Such testing could provide clinicians with a strong tool to balance immunosuppressive medications and avoid the two most important complications of transplantation: opportunistic infection and organ rejection," Dr. Kumar emphasized.
For Dr. Adam Testro, Head of Liver Immunology at the University of Melbourne, Austin Health, an ideal immune function test should be accessible, rapid, provide a marker of net immunity, not be affected by age or gender, and provide a warning of impending clinical events. "To date, QFM appears to satisfy many of these criteria. Results are available next day and the dual stimulation with innate and adaptive ligands confers a significant advantage over single-stimulant assays."
QIAGEN's QuantiFERON line of in-vitro diagnostics uses robust and clinically established interferon-gamma release assay (IGRA) technology for detection of cell-mediated immune responses from whole blood samples. Other products include QuantiFERON-TB Gold (QFT®) for accurate detection of latent tuberculosis (TB) infection, QuantiFERON-TB Gold Plus (QFT-Plus®) with several new enhancements, and QuantiFERON-CMV for monitoring immunity to cytomegalovirus (CMV) in at-risk patients.
To learn more about QuantiFERON testing technology, please visit http://www.QuantiFERON.com.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions to transform biological materials into valuable molecular insights. QIAGEN 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 molecular testing workflows. QIAGEN provides these workflows to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of September 30, 2014, QIAGEN employed approximately 4,200 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).
SOURCE QIAGEN N.V.