QIAGEN Introduces QuantiFERON Monitor® for Tracking Immune Function in Solid Organ Transplant Patients and for Research into Other Applications

QIAGEN N.V. has 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.