PATH and Mologic advance a new diagnostic test to support malaria elimination

Media contacts:

• Kate Davidson | PATH | media@path.org
• Mark Davis | Mologic | mark.davis@mologic.co.uk

Seattle, Washington, April 17, 2018—PATH and United Kingdom-based test developer Mologic have entered an agreement to advance a new rapid diagnostic test to support treatment and elimination of Plasmodium vivax, or relapsing, malaria.

More than 2.5 billion people worldwide are at risk of infection with P. vivax malaria, mainly in Southeast Asia and Latin America. P. vivax is especially difficult to eliminate because the parasite can lie dormant in the liver and re-emerge, causing periods of relapsing illness. With each relapse, patients become progressively sicker, and can continue to spread the disease through mosquitoes to other members of the community.

Treatment with 8-aminoquinolines, a class of drugs that includes primaquine, is currently the only means to kill the liver form of the P. vivax parasite and prevent the cycle of relapse and transmission. However, 8-aminoquinolines can cause serious side effects in patients with severe glucose-6-phosphate dehydrogenase (G6PD) deficiency, a hereditary condition common to areas where malaria is found. Therefore, the World Health Organization recommends testing patients for the condition before administering treatment with primaquine. Critically, diagnostic tests currently on the market for G6PD deficiency are neither simple enough to support their widespread use in low-resource areas nor robust enough to be used in the hot, humid areas where malaria is endemic.

PATH is advancing a portfolio of tests for G6PD deficiency that meet requirements for use in settings where P. vivax malaria is close to elimination. As part of this effort, PATH is working with Mologic to develop a novel qualitative point-of-care G6PD rapid diagnostic test (RDT). This new RDT has the potential to improve access to G6PD testing to support appropriate administration of primaquine. PATH and Mologic optimized the Mologic RDT for use in environmental conditions typical in malaria-endemic countries, resulting in a test that is designed for use including at the community level, where malaria is commonly diagnosed and treated. It provides simple results (i.e., positive or negative) that can be easily interpreted by test users to determine if a patient has severe G6PD deficiency and is therefore at increased risk for side effects if treated with primaquine. This qualitative G6PD RDT can provide a simple and affordable alternative to quantitative tests, which provide a numerical readout of G6PD levels but may be more expensive.

"This test will be a significant addition to the G6PD testing options available to health care providers to inform case management of patients with P. vivax malaria," says Dr. Gonzalo Domingo, scientific director and malaria diagnostics lead at PATH. "It will help to fill critical gaps in G6PD testing experienced by elimination programs, and will complement quantitative tests for G6PD deficiency being advanced by PATH and partners."

"We are honored to have developed this new rapid diagnostic test technology for G6PD deficiency that combines the direct measurement of enzyme activity into the simple lateral flow line format similar to that used in home pregnancy testing, based on Mologic's enzyme activity detection format," said Paul Davis, Mologic cofounder and chief scientific officer. "We would like to thank PATH for driving the development of this key test to support malaria treatment and leading efforts to bring the test to market. Mologic looks forward to continuing this partnership with PATH in advancing essential diagnostic technology to address important health issues."

The first product variant is expected to come to market in 2019. PATH is supporting Mologic to commercialize the RDT and obtain key regulatory approvals.

Funding to PATH to support advancement of new G6PD diagnostic tools has been provided by UKAid from the United Kingdom Department for International Development and the Bill & Melinda Gates Foundation.

PATH is the leader in global health innovation. An international nonprofit organization, PATH saves lives and improves health, especially among women and children. PATH accelerates innovation across five platforms—vaccines, drugs, diagnostics, devices, and system and service innovations—that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, PATH takes innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. With these key partners, PATH delivers measurable results that disrupt the cycle of poor health. Learn more at www.path.org.

We are part of the battle to control and eliminate malaria nationally and regionally, and ultimately to eradicate it worldwide. With our unparalleled portfolio of malaria projects, we are partnering with countries and organizations around the world to make malaria history. To learn more about PATH's work in malaria, visit https://www.path.org/our-work/malaria.php.

Mologic is a proven innovator in the design and development of rapid diagnostic products and technology. Having re-established its independence in 2014, the company has advanced an 11-product portfolio to pre-market evaluation, with BVPro® and PERiPLEX® products receiving CE mark approval in 2017. The remaining products are destined for launch in 2018 and 2019, including (but not limited to) the delivery of the world's first respiratory disease exacerbation monitor. The company's interests extend beyond human health care, with active programs in animal and fish disease diagnostics, agriculture diagnostics, and non-human vaccine innovation, collectively exploiting the advances in technology developed within the human sector.

Underpinning the new product development pathway, Mologic delivers high-value contract partnering programs for a range of national and international clients. Its broad range of skills and experience, including a unique low-volume manufacturing facility (ISO 13485 certified) and product assembly partnership with Adreco, enable the business to take on almost any project challenge, irrespective of complexity or stage.

In 2017, Mologic and the Bill & Melinda Gates Foundation established the Centre for Advanced Rapid Diagnostics (CARD) to invent and develop the next-generation point-of-care diagnostic technology platform for high sensitivity measurements. Prototype product formats are currently being validated that achieve 1 pg/mL sensitivity, yet cost less than US$1 at volume to manufacture.

Mologic is the ideal product development partner, providing the best reagents, products, and innovation, and offering fully harmonized service extending from idea through to initial product volumes. Through our trusted professional partnerships, successful products are transferred to high-volume manufacturing and distribution across the globe.