Germantown: QIAGEN Reaches Milestone With 100 Million QuantiFERON Tests Used to Detect TB

Used to test patients in over 130 countries, the fourth generation QuantiFERON^®-TB Gold Plus assay identifies interferon-gamma released by T-cells following recognition of TB specific antigens as a marker of TB infection. Interferon gamma release assays (IGRA) require only one patient visit to a healthcare provider and are more accurate than the traditional two-visit skin test that has been used for over a century to detect the latent form of the infection.

“Accurate testing across the globe is crucial in the fight against this deadly, but eminently curable disease,” said Dr. Aamir Khan, Executive Director of IRD Global, an international health delivery and research organization. “10 million people developed active TB disease in 2020, and they could have been identified and treated before they developed clinical symptoms and transmissible infection. Today is World TB Day, a chance to remind the world that most of the 1.5 million annual deaths are avoidable.”

QuantiFERON is the leading IGRA blood test. It has established itself as a superior alternative to the tuberculin skin test, which, for example, struggles to accurately identify TB infections in people who have received BCG vaccinations. QuantiFERON sets itself apart from other IGRA tests with streamlined workflow and using whole blood samples, not purified lymphocytes. QuantiFERON^®-TB Gold Plus has consistently shown a specificity of approximately 99%, providing confidence that it is detecting those truly infected.

“QIAGEN’s QuantiFERON technology renders the most accurate and reproducible results in TB testing – as hundreds of clinical and scientific studies have shown,” said Thierry Bernard, CEO of QIAGEN. “The milestone of 100 million tests is an important signal on World TB Day. We have the means to tackle TB – if the world again puts its mind to the task. Prior to the pandemic, TB was the world’s leading infectious disease killer. If we want to succeed in our efforts to end TB by 2030, we need to ramp up again international funding for TB which has suffered significantly over the past two years.”

QuantiFERON is one of five pillars in QIAGEN’s growth strategy. In 2021, the company launched QIAreach QFT, a battery-operated portable version developed in partnership with Ellume that is specifically designed for use in the fight against TB in low resource, high burden countries. The test has been approved by the Global Fund’s Expert Review Panel Diagnostics (ERPD), which means it can now be procured by public health programs and institutions in more than 100 countries that qualify for Global Fund and/or UNITAID resources. It is also being made widely available through the Stop TB Partnership’s Global Drug Facility (GDF).

The role of QuantiFERON^®-TB Gold Plus in fighting TB received a further boost in December 2021 when the US Food and Drug Administration removed limitations, following review of extensive data in the use of the test in patients with weakened immune systems, pregnant women and children. On top of this, QIAGEN is working with its partners to provide additional automation options that allow to reach more patients and to increase the number of diseases which the blood test can be used for – including SARS-CoV-2 and Lyme Disease.

Tuberculosis is a contagious bacterial infection spread primarily by coughing of patients with the active pulmonary form of the disease. In 2020, the World Health Organization (WHO) estimates that there were 10 million new cases of active TB worldwide and 1.5 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 out of four 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 plays 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.