QIAGEN Submits Tuberculosis Blood Test for FDA Pre-Market Approval

QIAGEN has announced the submission of QuantiFERON^®-TB Gold Plus (QFT^®-Plus), the fourth generation of the modern blood test for detecting tuberculosis (TB) infection, for pre-market approval (PMA) by the U.S. Food and Drug Administration (FDA).

The U.S. submission follows the launch during 2016 and positive uptake of QuantiFERON-TB Gold Plus in more than 60 countries across Europe, the Middle East, Africa, Asia and Latin America, where more than 600,000 of the new tests have already been used.

QFT-Plus builds on the foundation of QuantiFERON-TB Gold^® (QFT^®), the third-generation version of the world’s leading interferon gamma release assay (IGRA), which has been established as a cost-effective and efficient tool for TB infection testing with more than 30 million tests conducted worldwide since its initial launch. The fourth-generation QFT-Plus test adds proprietary CD8 antigens and workflow improvements that allow for even more efficient implementation, especially in large-scale TB screening programs. These include a single-tube blood collection option, as well as the current use of the unique "assay in collection tube" design that allows for immediate stimulation of the blood sample.

“We are very encouraged by the positive adoption and favorable early data for the fourth generation of QuantiFERON, and the role our test plays in the fight against TB. QFT-Plus is the only latent TB test on the pathway to evaluation by the World Health Organization (WHO), and we are excited that this new generation will soon be available in the United States. Bringing new insights for physicians to manage their patients and offering more efficiency to public health agencies are important hallmarks of QFT-Plus,” said Dr. Masae Kawamura, M.D., Senior Director, Medical and Scientific Affairs, TB Diagnostics at QIAGEN and a former TB controller for the city of San Francisco. “TB is both a global and mobile disease, greatly impacting the United States with up to 13 million people infected. QFT-Plus will help address the needs for expanded latent TB testing as we work to eliminate this preventable disease.”

Six independent peer-reviewed publications to date have supported the performance of QFT-Plus, and additional studies are currently underway in 22 countries involving more than 30,000 patients. The first studies include comparisons on sensitivity in active TB and close contacts, as well as on laboratory precision and correlation to flow cytometry.

Clinical benefits and cost-effectiveness drive QuantiFERON-TB test adoption

The transition to the fourth generation of the QuantiFERON TB test comes amid a series of new recommendations that will broaden the use of IGRAs in the United States.

In December 2016, a task force supported by the American Thoracic Society (ATS), the U.S. Centers for Disease Control and Prevention (CDC), and the Infectious Diseases Society of America, published new evidence-based guidelines recommending the use of IGRA tests in wider groups of people at risk for TB infection. This followed recommendations by the U.S. Preventive Services Task Force (USPSTF) in September 2016 that primary care physicians should screen adult patients in groups at high risk for latent TB infection.

Both the USPSTF and new ATS/CDC recommendations referred to QuantiFERON-TB Gold as one of two FDA-approved IGRAs, preferable in certain patient groups to the century-old tuberculin skin test (TST). The ATS/CDC recommendations also highlighted the expert committee’s rationale for expanded IGRA use based on the accuracy of IGRAs to minimize the risk of unnecessary TB treatment and related drug toxicity issues.

Tuberculosis is a contagious bacterial infection spread primarily by coughing of patients with the active pulmonary form of the disease. In 2015, WHO estimates, there were 10.4 million new cases of active TB worldwide and 1.8 million deaths from TB. In latent tuberculosis infection (LTBI), the bacterium infects a person but produces no symptoms unless it progresses to the active disease. On a global basis, approximately one-third of people are estimated to have latent TB infection, and about 5-10% of those individuals, if untreated, will progress to active tuberculosis at some point. Screening of high-risk individuals and treatment for LTBI play an important role in tuberculosis control efforts in the U.S. and many European countries, as well as in other developed and emerging markets around the world.

Building a portfolio on proven QuantiFERON technology

QFT-Plus is the latest product introduction involving the proprietary QuantiFERON^® technology, which offers a unique and efficient approach to disease detection. QuantiFERON is able to provide objective information on the activity of cell-mediated functions of the immune system by measuring the release of interferon-gamma in response to specific antigens or proteins contained in whole blood samples through a simple, highly automated process. QuantiFERON is in particular unique in its ability to detect presymptomatic infections and risks that cannot be discovered using standard diagnostic technologies. In addition to the TB infection tests, QIAGEN also offers a CE-marked version of QuantiFERON-CMV, a whole blood assay to monitor changes in cell-mediated immunity to cytomegalovirus (CMV), which is the most common and problematic viral infection in solid organ transplant recipients. Additional assays involving QuantiFERON are in development.