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Announcement · January 8, 2019

Ellume announces another global partnership with QIAGEN on the detection of tuberculosis

Ellume announces another global partnership with QIAGEN on the detection of tuberculosis
Ellume and QIAGEN Logos

Digital diagnostics firm Ellume Ltd (Ellume or “the Company**”**) has formed a strategic partnership with QIAGEN N.V. (NYSE: QGEN, Frankfurt Stock Exchange: QIA) to develop a proprietary new version of a QuantiFERON®-based tuberculosis (TB) test dedicated and tailored to the specific needs of low-resource regions with a high disease burden of TB.

The companies have partnered to develop a new testing solution, QuantiFERON®-TB QIAreach™ (QIAreach™ QFT), to pair Ellume’s ultrasensitive digital detection of latent TB infection with a complete testing workflow designed for cost-efficiency and ease of use. Its features allow QIAreach™ QFT to advance TB control in areas with limited infrastructure, in particular in countries in Asia, Africa and Latin America. The World Health Organization (WHO) has classified a group of 30 countries in these regions that are estimated to represent about 85% of the global burden for TB. QIAGEN intends to work with the WHO, various non-governmental organizations and governments to support their TB control efforts, and in particular achieve the goals set for the WHO’s End TB Strategy.

QuantiFERON Gold Plus is the market leader in the detection of latent TB and is on track to generate over $300M of annual sales by 2020, according to QIAGEN.

Ellume’s Founder and Managing Director, Dr Sean Parsons, said, “We’re pleased to be partnering with a global leader such as QIAGEN to create a high-impact product such as QIAreach™ QFT. TB, particularly as drug-resistant TB is an often-fatal bacterial infection and a serious threat to humankind. We are confident that Ellume’s technology will assist QIAGEN with detection of TB infections, leading to earlier identification and more effective treatment and containment in low-resource, high-burden countries. At Ellume, we pride ourselves on developing integrated solutions and we’re confident of creating with QIAGEN a world-class product in QIAreach™ QFT to address this major unmet need.”

“QuantiFERON-TB Gold Plus is rapidly winning adoption in developed markets as an important way to detect latent TB infections and prevent patients from developing the active form of this potentially deadly disease,” said Thierry Bernard, Senior Vice President of QIAGEN’s Molecular Diagnostics Business Area. “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 QIAreach™ 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 strengthen our support in the global fight against TB.”

“QuantiFERON-TB QIAreach™ represents the biggest technology breakthrough in LTBI testing since the first FDA approval of QuantiFERON-TB in 2001,” said Dr. Masae Kawamura, M.D., Senior Director, TB Medical and Scientific Affairs, at QIAGEN. “The ease of use and ability to get results with one visit with QIAreach™ QFT can address the evaluation of contacts in these high-burden regions that is currently not done due to lack of access to laboratories or the ongoing global shortage of high-quality tuberculin used in skin testing. The use of QIAreach™ QFT addresses the issues of cost and complexity with a solution dedicated and tailored to the specific needs of these regions, and provides a much-needed tool to help the world eliminate TB and achieve the UN and WHO goals.”

Tuberculosis (TB) is a contagious bacterial infection spread primarily through coughing by patients with the active pulmonary form of the disease. In latent tuberculosis infection, the bacterium infects a person but produces 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 programs 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 further contagion and reduce the disease burden.

The partnership includes use of the Ellume suite of intellectual property for the detection of latent TB. QIAGEN have also acquired a USD $ 15M minority investment in Ellume. This new platform has the potential to expand the product menu beyond latent TB to include other illnesses, particularly those co-incident with TB, such as HIV.

This announcement follows the news in December that Ellume has partnered with GlaxoSmithKline on an unrelated product. “To have this second partnership with a company such as QIAGEN is a real validation of the technology we’ve created over the last 5 years. It shows us to be the partner of choice for global leaders in the industry due to the quality and value of the science we have created. This is particularly important as our ellume·lab products enter U.S. clinical studies in preparation for planned commercial launch in 2020.”

ENDS

About Ellume

Ellume is an Australian-based digital diagnostics company that develops, manufactures and commercializes high-performance, connected products for health professionals and consumers. Our focus is on the detection of common illnesses which affect the global population and our products differ from conventional diagnostics through performance, digital connectivity, actionability and simplicity. Ellume has developed novel detection technology powered by our unique quantum dot nanoparticle, which integrates optics, electronics, biologics and software into an intuitive and high-performance digital platform. Ellume has a global partnership in consumer health with GlaxoSmithKline, a global partnership with QIAGEN in latent TB, and a range of professional products under the ellume·lab brand which are scheduled for U.S. launch in 2020. Further information can be found at www.ellumehealth.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 (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2018, QIAGEN employed approximately 4,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Investors
Dr Sean Parsons
Founder & Managing Director
E: [email protected]
T: +61 7 3393 1448

Media & General Inquiries
Ben Walsh
WE Buchan
E: [email protected]
M: +61 411 520 012

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