QIAGEN Expands QuantiFERON Portfolio in the Fight Against TB

Rhea-AI Summary

QIAGEN N.V. (NYSE: QGEN) announced significant expansions to its QuantiFERON franchise, enhancing its tuberculosis detection capabilities and introducing new applications for latent disease detection. The QuantiFERON SARS-CoV-2 assay, launched in December 2021, has received CE marking to measure T-cell responses to COVID-19. Additionally, the QuantiFERON-TB Gold Plus assay now includes more patient groups as approved by the FDA. The QIAreach QuantiFERON-TB test aims to improve TB detection in resource-limited settings and is now approved for public health procurement in over 100 countries.

Positive

• Expansion of QuantiFERON franchise enhances TB detection and explores new disease applications.
• QuantiFERON SARS-CoV-2 assay gains CE mark, broadening utility in assessing COVID-19 immunity.
• FDA approval expands target groups for TB detection, including vulnerable populations.
• QIAreach QuantiFERON-TB test approved for procurement in over 100 countries.

Negative

• None.

• 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 2021 now 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

HILDEN, Germany & GERMANTOWN, Md.--(BUSINESS WIRE)-- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today 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.

“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 Jenny Howard, Vice President, Head of the Global Immune Response franchise at QIAGEN. “The recent developments add a series of new applications, products and automation options that are broadening its reach. We are determined to further expand the range of applications for our immune response technology in the coming years.”

Among recent developments:

• 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 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. 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.

For more information, please visit http://www.qiagen.com and https://www.quantiferon.com/

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 December 31, 2021, QIAGEN employed more than 6,000 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

Category: Corporate

View source version on businesswire.com: https://www.businesswire.com/news/home/20220106005851/en/

QIAGEN:

Investor Relations

John Gilardi +49 2103 29 11711

Phoebe Loh +49 2103 29 11457

e-mail: ir@QIAGEN.com

Public Relations

Thomas Theuringer +49 2103 29 11826

e-mail: pr@QIAGEN.com

Source: QIAGEN N.V.

FAQ

What recent developments has QIAGEN announced regarding its QuantiFERON franchise?

QIAGEN announced expansions in the QuantiFERON franchise focusing on tuberculosis and latent disease detection, including the CE marking of the QuantiFERON SARS-CoV-2 assay.

What is the significance of the FDA approval for the QuantiFERON-TB Gold Plus assay?

The FDA approval allows the QuantiFERON-TB Gold Plus assay to test additional patient groups, such as those with weakened immune systems, pregnant women, and children.

How many countries can now access the QIAreach QuantiFERON-TB test?

The QIAreach QuantiFERON-TB test has been approved for procurement in over 100 countries.

When was the QuantiFERON SARS-CoV-2 assay launched?

The QuantiFERON SARS-CoV-2 assay was launched in December 2021.