QIAGEN Launches New QIAreach QuantiFERON-TB TB Control Test for High Burden Areas
HILDEN, Germany & GERMANTOWN, Maryland – (COMMERCIAL THREAD) – QIAGEN NV (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch and CE mark of the QIAreach® QuantiFERON®-TB test for tuberculosis infection (TB), to help achieve global TB elimination goals by increasing access to easy and reliable TB testing, especially in high-workload countries and low-resource areas.
An important step in the fight against a pathogen estimated at more than two billion people in the world, built on the proven QuantiFERON-TB Gold Plus technology, QIAreach® QuantiFERON®-TB is a portable device that enables the highly sensitive digital detection of tuberculosis infection with a simple and cost-effective end-to-end workflow that increases access to reliable gamma interferon release assay (IGRA) assays. QIAGEN will focus on regions facing a high disease burden and where access to laboratory infrastructure and resources for testing is limited.
“With QIAreach QuantiFERON-TB, we have taken a big step forward in leaving no one behind with a fatal disease like tuberculosis that is preventable and curable. With this revolutionary new way to detect TB infections, we can help 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 highly portable and user-friendly digital device to deliver extremely reliable results without the need for complex laboratory infrastructure at a cost effective.
A quantum leap from the traditional tuberculosis skin test, QuantiFERON-TB uses blood samples to test for interferon-gamma molecules released by T cells that have come into contact with tuberculosis bacteria. QIAreach QuantiFERON-TB runs these tests on the eHub and eStick digital system, a true stand-alone solution with random access and no calibration or maintenance. The QIAreach QuantiFERON TB assay requires a patient visit and produces an easy-to-read result within 20 minutes of sample incubation, with the ability to save and send results for better data management, which makes it ideal for TB screening programs.
QIAGEN will work with commercial distribution partners as well as the Stop TB Partnership global pharmacy service to ensure affordable access in all high burden, low income and middle income countries. In parallel, QIAGEN will continue to work closely with various international organizations and public health institutions to help 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 the United Nations Sustainable Development Goals to end TB,” said Dr Lucica Ditiu, Executive Director of the Stop TB Partnership. “The COVID-19 pandemic has seen nine of the countries with the most tuberculosis cases reduce diagnosis and treatment of the disease from 16% to 41%, bringing us back to 2008 levels. Without rapidly deploying new tools, the commitments taken by heads of state to find and treat 40 million people by the end of 2022 will not be required.
Clinical evaluations of the test have demonstrated excellent agreement as well as high sensitivity to QuantiFERON-TB Gold Plus, the most widely recognized and globally marketed IGRA benchmark test in the world by QIAGEN. The new QIAreach QuantiFERON-TB test has been evaluated at Nagasaki Genbaku Isahaya Hospital, Japan, and the six sites of the Zambart project (Zambia), and has been shown to be a new portable and easy-to-use test that can be implemented with minimal infrastructure for the diagnosis of TB infection.
Published study results are available here: https://www.sciencedirect.com/science/article/pii/S2531043721001513
Results of additional studies from Malaysia on QIAreach QuantiFERON-TB will also be presented in a symposium at 52sd The Union’s Annual Global Lung Health Conference October 19e-22 2021, held virtually this year. Further details and information about the event can be found here: https://theunion.org/our-work/conferences/52nd-union-world-conference-on-lung-health
For more information on the QIAreach QuantiFERON-TB platform, visit http://www.qiagen.com/qiareach
QIAGEN NV, a Netherlands-based holding company, is the world’s leading provider of Sample to Insight solutions that enable customers to gain valuable molecular information from samples containing the building blocks of life. Our sampling technologies isolate and process DNA, RNA and proteins from blood, tissues and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to yield relevant and actionable information. Automation solutions connect them in transparent and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers worldwide in the fields of molecular diagnostics (human health) and life sciences (universities, pharmaceutical R&D and industrial applications, mainly forensic). As of June 30, 2021, QIAGEN employed approximately 5,900 people at more than 35 locations around the world. Further information is available at http://www.qiagen.com
Certain statements contained in this press release may be considered as forward-looking statements within the meaning of Section 27A of the US Securities Act of 1933, as amended, and Section 21E of the US Securities Exchange Act of 1934, as ‘fine. To the extent that any of the statements contained herein regarding QIAGEN’s products, including products used in the COVID-19 pandemic response, launch and development schedule, marketing approvals and / or regulatory, financial and operational outlook, growth and expansion, collaborative markets, strategy or operating results, including, without limitation, its expected adjusted net sales and diluted earnings results adjusted, are forward-looking, these statements are based on current expectations and assumptions which involve a number of uncertainties and risks. These uncertainties and risks include, but are not limited to, risks associated with managing growth and international operations (including the effects of currency fluctuations, regulatory processes and reliance on logistics), variability in operating results and allocations between customer categories; commercial development of markets for our products to academic, pharmaceutical, applied testing and molecular diagnostics customers; changing relationships with customers, suppliers and strategic partners; competetion; rapid or unexpected technological changes; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, level and timing of customer financing, budgets and other factors); our ability to obtain regulatory approval for our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; QIAGEN’s ability to identify and develop new products and to differentiate and protect our products from competitive products; market acceptance of new QIAGEN products and integration of acquired technologies and businesses; government actions, global or regional economic developments, weather or transport delays, natural disasters, political or public health crises, including the extent and duration of the COVID-19 pandemic and its impact on demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that the expected benefits associated with recent or ongoing acquisitions will not materialize as expected; and the other factors discussed under the heading “Risk Factors” in Item 3 of our most recent Annual Report on Form 20-F. For more information, please refer to the discussions in the reports that QIAGEN has filed with, or provided to, the United States Securities and Exchange Commission.
Source: QIAGEN SA