Qiagen (QGEN) Status update summary

Market landscape and opportunity

• Tuberculosis is the leading infectious disease killer, with 1.6 million deaths annually and two billion people affected by latent TB.

• The latent TB testing market is estimated at $1.6 billion annually, with 75 million tests performed each year and only 40% converted from skin tests to IGRA-based assays.

• Over 45 million additional tests could be unlocked by converting skin tests, with 15–16 million in the U.S. alone.

• Market growth is driven by increased demand among immunocompromised and biologics patients, with underlying growth estimated at 4-5% annually.

Innovation and product development

• QuantiFERON has evolved to a fourth-generation assay with patented CD4/CD8 antigen technology, enhancing sensitivity for immunocompromised patients.

• The new CLIA II chemistry, launched in Europe and the U.S., enables 75% more tests per hour and 25% faster turnaround.

• Partnerships with Diasorin and Inpeco enable workflow standardization and full automation, with a fully automated, end-to-end workflow targeting FDA and CE approval by 2027.

• The automation ecosystem includes a dedicated aliquoter, intelligent incubation, and seamless integration with LIAISON XL for detection, scalable across lab sizes.

AI-enabled risk stratification and clinical value

• An AI tool, built on 13 million de-identified patient records and over 20 years of data, will support clinicians in identifying patients at highest risk of TB progression.

• The tool leverages unique CD4/CD8 data, integrates with CDC guidelines, and is exclusive to QuantiFERON workflows, with launch targeted for 2027.

• AI-driven risk scores aim to improve patient compliance, enable personalized treatment, and enhance clinical decision-making.