HILDEN, Germany & GERMANTOWN, Md.-- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch and CE marking of QIAreach® QuantiFERON®-TB test for tuberculosis (TB) infection, in order to help achieve global TB elimination targets by increasing access to easy and reliable TB testing, especially in high burden countries, low-resource regions.
A milestone in the fight against a pathogen estimated to be carried by over two billion people worldwide, built on the proven QuantiFERON-TB Gold Plus technology, QIAreach® QuantiFERON®-TB is a portable device that enables the ultrasensitive digital detection of TB infection with an end-to-end workflow that is simple and cost efficient, and increases access to reliable Interferon Gamma Release Assay (IGRA) testing. QIAGEN will focus on regions that face a high burden of the disease, and where getting access to lab infrastructure and resources for testing are limited.
“With QIAreach QuantiFERON-TB we have taken a great step towards leaving no one behind when facing a deadly disease like tuberculosis that is preventable and curable. With this groundbreaking new way to detect TB infections we can aid to prevent patients, especially those in high burden countries, from developing the active form of TB,” said Thierry Bernard, CEO of QIAGEN. “It combines QIAGEN’s proven QuantiFERON-TB technology with a very portable and field-friendly digital device to deliver extremely reliable results without the need for complex laboratory infrastructure at effective cost.”
A quantum leap from the traditional TB skin test, QuantiFERON-TB uses blood samples to test for interferon-gamma molecules released from T-cells that have come into contact with TB bacteria. QIAreach QuantiFERON-TB runs these tests on the digital eHub and eStick system, a true walkaway solution with random access and no calibration or maintenance. QIAreach QuantiFERON TB testing requires one patient visit and produces an easy-to-read result in 20 minutes after sample incubation, with the ability to record and send results for improved data management, making it ideal for TB screening programs.
QIAGEN will work with commercial distribution partners as well as the Stop TB Partnership’s Global Drug Facility to ensure affordable access across all high burden, low and middle-income countries. In parallel, QIAGEN will continue its close collaboration with a variety of international organizations and public health institutions to help drive scale-up through innovative implementation projects.
“Lack of access to the latest diagnostic tests is just one of the reasons the world is not on track to meet UN Sustainable Development goals to end TB,” said Dr. Lucica Ditiu, Executive Director of the Stop TB partnership.
“The COVID-19 pandemic saw nine of the countries with the most TB cases cut diagnosis and treatment of the disease by 16-41 percent, setting us back to 2008 levels. Without rapidly rolling out new tools, the commitments made by heads of states to find and treat 40 million people by the end of 2022 will not be met.”
Clinical evaluations of the test demonstrated an excellent level of agreement as well as high sensitivity when compared with QuantiFERON-TB Gold Plus, the most recognized, gold standard IGRA marketed worldwide by QIAGEN.
The new QIAreach QuantiFERON-TB test was assessed at the Nagasaki Genbaku Isahaya Hospital, Japan, and the six Zambart project sites (Zambia), and shown to be a novel portable and simple-to-use assay that can be implemented with minimal infrastructure for the diagnosis of TB infection.