QIAGEN Expands QuantiFERON Portfolio in the Fight Against TB
- QuantiFERON franchise benefits from new applications, products and automation options, building on strengths in tuberculosis detection while addressing new disease targets
- QuantiFERON SARS-CoV-2 assay launched in
December 2021now CE-marked for clinical use measuring SARS-CoV-2 T-cell responses
- QuantiFERON-TB Gold Plus assay for TB detection set to benefit from three additional
U.S.patient groups: Individuals with weakened immune systems, pregnant women and children
- QIAreach QuantiFERON-TB set for commercialization in 2022, designed specifically to improve TB detection in high burden, low resource countries
The new initiatives are expected to help drive further growth of the QuantiFERON franchise. A quantum leap from the traditional TB skin test, QuantiFERON-TB uses blood samples to test for interferon-gamma that is released from T-cells that have come into contact with TB bacteria.
“QuantiFERON is gaining further traction and is set to continue to make an impact on improving outcomes for people around the world, first through its proven gold standard status for detection of TB, while also benefiting from new applications, in particular in the global fight against COVID-19,” said
Among recent developments:
QIAGENis experiencing strong customer interest in the QuantiFERON SARS-CoV-2 assay, which was launched in December 2021and has now received a European CE mark. This test measures T-cell responses to SARS-CoV-2 and aids in the assessment of immunity in individuals who have received COVID-19 vaccination. T-cell response to SARS-CoV-2 decline more slowly than antibody responses and may indicate how severe the course of an illness triggered by SARS-CoV-2 will be in infected patients. The QuantiFERON SARS-CoV-2 assay detects CD4+ and CD8+ T-cell responses, which enables a more comprehensive assessment of immunity generated by COVID-19 vaccines, including clinically vulnerable individuals.
- Based on a review of extensive studies, the range of target groups that can be tested with the blood-based QuantiFERON-TB Gold assay for detection of TB has been expanded by the
U.S. Food and Drug Administration(FDA) to include individuals with weakened immune systems, pregnant women and children, and also following changes to U.S. CDC( Centers for Disease Control) guidelines.
- The battery-operated QIAreach QuantiFERON-TB test (QIAreach QFT), which was specifically designed for use in the fight against TB in low resource, high burden countries, has been approved by the Global Fund’s
Expert Review Panel Diagnostics(ERPD). This approval means QIAreach QFT may now be procured by public health programs and institutions in more than 100 countries that qualify for Global Fundand/or UNITAIDresources, as well as made available through the Stop TB Partnership’s Global Drug Facility(GDF). This development comes after launch in the fourth quarter of 2021, and opens an important new channel given that the GDF is the largest provider of TB drugs and diagnostics to the public sector. QIAreach QFT offers 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. QIAGENwill focus on emerging market regions where access to laboratory infrastructure and resources for testing are limited. QIAreach QuantiFERON-TB was developed in collaboration with Ellume.
Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the