QIAGEN N.V. announced important expansion initiatives for its QuantiFERON franchise, building on its status as the gold standard for detection of tuberculosis, while developing new applications for this technology designed to detect potentially deadly latent diseases. 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.

QIAGEN is experiencing strong customer interest in the QuantiFERON SARS-CoV-2 assay, which was launched in December 2021 and 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 Fund and/or UNITAID resources, 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 larger 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.

QIAGEN will 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.