Digital diagnostics company Ellume announced its new tech 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 QuantiFERON-TB test (QIAreach QFT)—which was developed with Ellume technology—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).

“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,” says Sean Parsons, BSc, 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 collaboration between Ellume and QIAGEN N.V. 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 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.