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Qiagen Obtains CE Mark for Point-of-Care Tuberculosis Infection Test

NEW YORK – Qiagen said after the close of the market on Tuesday that it has received CE marking for the QiaReach QuantiFeron-TB test for tuberculosis infection.

Accordingly, Qiagen has commercially launched the test in areas of the world recognizing CE marking, specifically focusing on high-burden, low- and middle-income countries. The company said it will work with commercial distribution partners and the Stop TB Partnership's Global Drug Facility to ensure affordable access in these regions.

"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," Lucica Ditiu, executive director of the Stop TB Partnership, said in a statement. "The COVID-19 pandemic saw nine of the countries with the most TB cases cut diagnosis and treatment of the disease by 16 to 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."

The new test comprises Qiagen's QuantiFeron-TB Gold Plus assay, which has previously received regulatory approval in multiple regions of the world including Europe and the US, running on the portable digital eHub and eStick system, developed with Australian diagnostics firm Ellume. Earlier this year Qiagen received US Food and Drug Administration Emergency Use Authorization for a pair of COVID-19 tests running on the same platform.

QuantiFeron-TB Gold Plus is an immunoassay that uses blood samples to test for interferon-gamma molecules released from T cells that have come into contact with TB bacteria. 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 said. Running the test on the eHub/eStick system makes it "a true walkaway solution with random access and no calibration or maintenance," Qiagen said.

Qiagen noted that the new assay was clinically evaluated by researchers at the Nagasaki Genbaku Isahaya Hospital in Japan and six sites in Zambia. The results of that study were published in early August in Pulmonology, and showed that the rapid, digital test had 98.8 percent concordance with the standard QuantiFeron assay, with the researchers stating that it is "potentially … a useful point-of-care screening test for TB infection in high-TB-burden, low-resource countries and for immunocompromised patients."