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Announcement · January 10, 2022

Next generation TB test receives approval from key global review panel

QIAreach QFT result of groundbreaking collaboration between Ellume and global life sciences and diagnostics company QIAGEN N.V.
QuantiFERON-TB test in use

Digital diagnostics company Ellume today announced that the QIAreach QuantiFERON-TB test (QIAreach QFT), developed with Ellume technology, and designed to advance the control of tuberculosis (TB) in areas with limited infrastructure, has been approved by the Global Fund's Expert Review Panel for Diagnostics.  Approval of QIAGEN N.V.'s battery-operated QIAreach QFT means the product will now be available to public health programs and institutions in more than 100 countries that qualify for Global Fund and/or UNITAID resources, as well as through the Stop TB Partnership's Global Drug Facility (GDF). This development comes after the QIAreach QFT product was launched in October 2021, following CE marking.

"In countries around the world, effective diagnosis and treatment of tuberculosis remains a huge unmet need. We created this market-changing, high-impact product in collaboration with QIAGEN to address that need. The approval of QIAreach QFT by the Global Fund's Expert Review Panel for Diagnostics represents a tremendous step forward in fighting a disease that affects approximately 25% of the global population, killing 1.5 million people every year," said Dr. Sean Parsons, Founder and Chief Executive of Ellume. "We are proud of the vital role Ellume plays in combatting this serious threat to humankind and are especially pleased to continue partnering with a global leader like QIAGEN on this important mission."

The Global Fund's Expert Review Panel for Diagnostics' approval of QIAreach QFT is the latest significant development in the groundbreaking collaboration between Ellume and QIAGEN N.V. which was announced in 2019. The collaboration paired Ellume's ultrasensitive digital detection of latent TB infection, with a complete testing workflow designed for efficiency and ease of use.  This high-impact product is set to play a significant role in ongoing efforts by the World Health Organization (WHO), various non-governmental organizations and governments to control TB – particularly in high burden countries in Asia, Africa and Latin America, where laboratory infrastructure and resources for testing are limited – in order to achieve the goal of the WHO's End TB Strategy to end the epidemic by 2030.

Tuberculosis is a contagious bacterial infection spread primarily through coughing by patients with the active pulmonary form of the disease. In latent tuberculosis infection there are no symptoms unless it progresses to active disease, at which stage the patient is highly contagious. The WHO estimates that up to one third of the world's population is infected with latent tuberculosis, with 5-10% of these going on to develop active TB disease in their lifetime. As part of comprehensive program to eradicate TB, WHO and other international organizations have expanded their guidelines for screening high-risk individuals and treating those with latent infection to help prevent progression to active disease to reduce mortality and morbidity and further contagion.

Ellume is a digital diagnostics company that develops, manufactures, and commercializes high-performance, connected products for healthcare professionals and consumers. It is at the forefront of accurate, rapid and accessible testing that is integral to today's COVID-19 response and will help ensure the world is prepared for the next infectious disease pandemic. Ellume's key focus is on the detection of common infectious diseases which affect the global population across all diagnostic settings; at-home, point-of-care and in-laboratory. Ellume has a partnership with global diagnostic company QIAGEN for the detection of COVID-19 and Tuberculosis (TB), as well as a range of professional-use products under its ellume·lab brand. Ellume is committed to developing high-quality digital diagnostics that the world can rely on in a health crisis.

Further information can be found at ellumehealth.com.

U.S. Media Inquiries

Seven Letter for Ellume
E: ellume@sevenletter.com
M: +1 202-315-2386

Australian Media InquiriesPatrick Condren, Ellume
E: Patrick.condren@ellumehealth.com
M: +61 405 186 630

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