Partnership Expands to Advance Novel Dual-Detection of Two Neglected Tropical Diseases

PATH (Seattle, WA, USA), a non-profit leader in global health equity, Signal Diagnostics (Seoul, Korea), a company of Alere Inc. (Waltham, MA, USA), and the [US] National Institute of Allergy and Infectious Diseases (NIAID) will collaborate on a rapid point-of-care combined test for both onchocerciasis (river blindness) and lymphatic filariasis (LF, elephantiasis), often co-endemic diseases.

The new biplex test will build on momentum of the current partnership between the three organizations to manufacture and distribute the recently launched Alere SD BIOLINE Onchocerciasis IgG4 rapid test. Their expanded partnership paves the way for PATH to transfer the technology to SD/Alere to manufacture and distribute the only antibody test for dual-detection of onchocerciasis and LF designed for use in rural and remote settings.

Of about 126 million at risk for river blindness, 99% live in Africa. Of about 1.39 billion at risk for LF, the vast majority live in Africa and in parts of Asia. Both commonly affect the same communities and cause great suffering, adding to the cycle of illness and poverty that impacts many remote areas of the world. The World Health Organization (WHO) has targeted both diseases for elimination by 2020. To stop transmission, control and elimination programs use the drug ivermectin, with a second drug added for LF. Accurate surveillance data are required to inform program decisions about stopping treatment of one or both drugs and detecting signs of reinfection.

The biplex test is based on detection of antibodies to parasite antigens Ov16 for onchocerciasis and Wb123 for LF. Both antigens were identified and characterized by scientists at NIAID. Field evaluations of the test will be conducted in the first half of 2015.

The dual-detection capability of the rapid Ov16/Wb123 test is designed to fill gaps in control programs in Africa where the diseases are co-endemic. Potential advantages include reduced cost, simplified use and logistics, and improved coordination of decision-making. The test can also be used to support disease elimination phase by monitoring post-control areas and detecting cases in low-prevalence areas.

“We are pleased to collaborate with PATH to develop another rapid test, this time for detecting onchocerciasis and lymphatic filariasis within one device,” said Byung-Ki Cho, vice president, Asia Pacific operations and R&D at SD/Alere, “The collaboration between SD/Alere, PATH, and NIAID will help eliminate and eradicate neglected tropical diseases.” “We are very happy to continue with SD/Alere as our commercialization partner for the new Ov16/Wb123 biplex rapid test,” said Tala de los Santos, director of diagnostics at PATH, “The new test bears great promise as a cost-effective diagnostic solution for supporting integrated surveillance activities.”

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