Dutch molecular diagnostics company Qiagen is set to develop a new version of its QuantiFERON-based tuberculosis (TB) test tailored to the requirements of low-resource regions with high rates of TB.

The new QuantiFERON TB Access will combine digital detection of latent TB infection and a complete workflow. The testing solution focuses on cost efficiency and ease of use.

QuantiFERON TB Access will be developed in alliance with Australian digitally-enabled diagnostics firm Ellume. The assay is designed to avoid cross-reactivity with BCG vaccines and the majority of the environmental mycobacteria, which commonly lead to false-positive skin test results.

“The test is scheduled to enter into clinical trials this year, with commercialisation planned for next year.”

The test is intended to improve TB control in regions with limited infrastructures, such as Asia, Africa and Latin America.

Qiagen Molecular Diagnostics business area senior vice-president Thierry Bernard said: “Despite the urgent need for more latent TB testing in low-resource, high-burden parts of the world, a lack of infrastructure and shortage of trained technicians make adoption of modern tests challenging.

“QuantiFERON-TB Access offers a novel solution for this challenge by combining the proven clinical insights of QuantiFERON-TB with Ellume’s digital technologies to deliver cost-efficient results quickly and without need for a laboratory, and a further signal of our support in the global fight against TB.”

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QuantiFERON TB Access can be quickly integrated within screening programmes meant for TB control in low-resource regions. The product usage is said to require limited healthcare worker training.

Qiagen added that the new test has the potential for latent TB testing in combination with other tests, including those for HIV infection. It could also be used to detect other disease targets in the future.

The test is scheduled to enter into clinical trials this year, with commercialisation planned for next year.

Furthermore, Qiagen has signed an agreement to acquire US-based molecular decision support company N-of-One for an undisclosed amount.

N-of-One’s solutions will be combined with Qiagen Clinical Insight (QCI) to create a clinical offering with medical interpretation and real-world evidence insights that provide decision support in the oncology field.