KEYPOINTS:
- QIAGEN (QGEN) and DiaSorin said that the U.S. Food and Drug Administration has approved the LIAISON QuantiFERON-TB Gold Plus assay for use on DiaSorin’s automated LIAISON XS platform.
- LIAISON QuantiFERON-TB Gold Plus is developed to streamline laboratory automation for latent tuberculosis (TB) screening.
- Additional U.S. approval for LIAISON XS platform builds on FDA approval in 2019 for QuantiFERON assay running on DiaSorin’s LIAISON XL analyzer
- Collaboration now provides a full range of automation platforms for TB testing options to customers, ranging from small healthcare clinics to larger hospitals and reference laboratories
- QIAGEN’s QuantiFERON Interferon Gamma Release Assay (IGRA) technology is the leading assay for the detection of latent TB with a high clinical sensitivity
The USFDA approves Qiagen’s QuantiFERON-TB Gold Plus Assay for use on DiaSorin’s automated Liaison XS Platform for TB Testing
QIAGEN and DiaSorin announced that the U.S. Food and Drug Administration (FDA) has approved the LIAISON QuantiFERON-TB Gold Plus assay for use on DiaSorin’s automated LIAISON XS platform.
The approval widens the accessibility of U.S. customers to automation solutions for processing QIAGEN’s leading blood-based test for latent tuberculosis (TB) detection and supports the conversion from the traditional tuberculin skin tests that were developed over a century ago.
The highly automated workflow on LIAISON platforms gives QuantiFERON customers a powerful, flexible automated option for all throughput ranges. The addition of the fully automated LIAISON XS platform to the already approved use of this assay on the LIAISON XL version expands the range of potential customers to include experts at smaller healthcare clinics alongside those at larger hospitals and medical centers and reference laboratories.
“QuantiFERON-TB Gold Plus continues to set new standards in the global fight against TB, a disease that remains a persistent killer and impacts people around the world,” said Thierry Bernard, CEO of QIAGEN N.V. “Our partnership with DiaSorin has enabled customers to absorb the increasing demand for TB detection with access to a proven automation solution on the LIAISON XL platform, especially in larger reference labs and hospitals. The addition of the LIAISON XS platform will open up new joint opportunities for us to reach new customer segments requiring lower-throughput options.”
Carlo Rosa, CEO of DiaSorin Group, commented: “Today we announce the approval of our first PMA assay available on the LIAISON XS platform. This solution is a key milestone of our LIAISON XS strategy in the U.S., where the test was already successfully launched in 2019 on our LIAISON XL platform. Making this test available with our partner QIAGEN for use on the LIAISON XS benchtop solution is part of our plan to increase adoption of this highly automated solution on a platform that is suitable for smaller-size laboratories.”
LIAISON® QuantiFERON®-TB Gold Plus is an interferon-gamma release assay (IGRA) developed by QIAGEN and DiaSorin to offer streamlined laboratory automation for latent TB screening. QuantiFERON-TB – which tests for interferon-gamma released from T-cells that have encountered TB bacteria – has been available on LIAISON® XL platforms in the U.S. since 2019.
QIAGEN and DiaSorin will continue to cooperate closely on the promotion and sale of their joint solutions for TB testing to make sure their customers reap the full benefit of their collaboration.
About Tuberculosis:
A potentially serious infectious bacterial disease that mainly affects the lungs.
The bacteria that cause TB are spread when an infected person coughs or sneezes.
Most people infected with the bacteria that cause tuberculosis don’t have symptoms. When symptoms do occur, they usually include a cough (sometimes blood-tinged), weight loss, night sweats, and fever.
TB is one of the biggest global healthcare problems. About one-third of the world’s population is estimated by the World Health Organization (WHO) to carry the infection in its latent form – about 2.5 billion people. Left untreated, up to 10% of them will become active TB sufferers. The disease is one of world’s top 10 causes of death, claiming around 1.7 million victims each year.
The highly contagious bacterial infection is spread primarily through coughing by patients with the active, lung-based form of the disease. But the bacterium can also cause infection without disease symptoms, a condition known as latent tuberculosis (LTBI). As part of programs to eradicate TB, the WHO and other international organizations have expanded guidelines for screening high-risk individuals and treating those with LTBI to help prevent further contagion.
Facts about TB:
- A total of 1.5 million people died from TB in 2020 (including 214 000 people with HIV). Worldwide, TB is the 13th leading cause of death and the second leading infectious killer after COVID-19 (above HIV/AIDS).
- In 2020, an estimated 10 million people fell ill with tuberculosis (TB) worldwide. 5.6 million men, 3.3 million women and 1.1 million children. TB is present in all countries and age groups. But TB is curable and preventable.
- In 2020, 1.1 million children fell ill with TB globally. Child and adolescent TB is often overlooked by health providers and can be difficult to diagnose and treat.
- In 2020, the 30 high TB burden countries accounted for 86% of new TB cases. Eight countries account for two thirds of the total, with India leading the count, followed by China, Indonesia, the Philippines, Pakistan, Nigeria, Bangladesh and South Africa.
- Multidrug-resistant TB (MDR-TB) remains a public health crisis and a health security threat. Only about one in three people with drug resistant TB accessed treatment in 2020.
- Globally, TB incidence is falling at about 2% per year and between 2015 and 2020 the cumulative reduction was 11%. This was over half way to the End TB Strategy milestone of 20% reduction between 2015 and 2020.
- An estimated 66 million lives were saved through TB diagnosis and treatment between 2000 and 2020.
- Globally, close to one in two TB-affected households face costs higher than 20% of their household income, according to latest national TB patient cost survey data. The world did not reach the milestone of 0% TB patients and their households facing catastrophic costs as a result of TB disease by 2020.
- By 2022, US$ 13 billion is needed annually for TB prevention, diagnosis, treatment and care to achieve the global target agreed at the UN high level-meeting on TB in 2018.
- Funding in low- and middle-income countries (LMICs) that account for 98% of reported TB cases falls far short of what is needed. Spending in 2020 amounted to US$ 5.3 billion less than half (41%) of the global target.
- There was an 8.7% decline in spending between 2019 and 2020 (from US$ 5.8 billion to US$ 5.3 billion), with TB funding in 2020 back to the level of 2016.
- Ending the TB epidemic by 2030 is among the health targets of the United Nations Sustainable Development Goals (SDGs).
About QIAGEN:
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2021, QIAGEN employed approximately 6,000 people in over 35 locations worldwide.
About DiaSorin:
Headquartered in Italy and listed at the Italian Stock Exchange in the FTSE MIB Index, DiaSorin is a global leader in the In Vitro Diagnostic (IVD) field and is active since 2021 in the Life Science business. For over 50 years, the Company has been developing, producing and marketing reagent kits used by diagnostic laboratories worldwide. The Group operates in 5 continents through 45 companies, 4 branches, 10 manufacturing facilities and 9 research and development centers. The extensive diagnostic testing and Life Science offer, made available through continuous investments in research, positions DiaSorin as the player with the broadest range of specialty tests available within the diagnostic market, and identifies the Group as the “Diagnostic Specialist”.
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