Standard Diagnostics and PATH collaborate to produce a point-of-care rapid test for the neglected tropical disease onchocerciasis

Contact:
Amy MacIver, 206.302.4522, amaciver@path.org.

Seattle and Seoul, October 18, 2012–PATH and Standard Diagnostics, Inc., (SD) announce their intent to enter into a commercialization agreement whereby SD will manufacture and distribute a novel Ov16 rapid test for the neglected tropical disease onchocerciasis, commonly known as river blindness.

Onchocerciasis is a major cause of preventable blindness in Africa. Transmitted to humans through bites of blackflies, it typically affects poor, rural communities near fast-flowing streams and rivers. An estimated 180 million people are at risk for the disease, and 37 million people are infected.

The Ov16 rapid test is based on the detection of antibodies to the parasite antigen Ov16. The Ov16 antigen was identified by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, an agency of the US Department of Health and Human Services. NIAID also evaluated the Ov16 rapid test developed at PATH. Funding to PATH to develop the Ov16 rapid test was and continues to be provided by the Bill & Melinda Gates Foundation.

The new point-of-care test addresses limitations of existing diagnostic tools currently in use. Programs to control blackflies with insecticides and mass treatment of affected communities with Mectizan®, donated by Merck & Co., have succeeded in reducing the disease burden. The Ov16 rapid test can be used to support such programs as they move to the disease elimination phase by monitoring post-control areas for signs of reinfection and for detecting cases in low-prevalence areas.

"We see this collaborative relationship with PATH as a valuable extension of our focus to becoming a global leader in the underserved area of neglected tropical diseases," says SD's recently appointed CEO, Dr. B.K. Cho. "PATH is an internationally recognized leader in global health solutions for low-resource countries and we are fortunate to work with them on this project."

"Following an extensive global due diligence process to identify potential manufacturing and distribution partners for the Ov16 test, we are delighted to work with Standard Diagnostics as our collaborative commercialization partner," said Tala de los Santos, PATH's diagnostic group leader and onchocerciasis project leader. "SD's manufacturing facilities are internationally competitive, and their distribution area covers the majority of the African countries endemic for onchocerciasis. Both of these factors are important if we are to achieve global access to the product."

Standard Diagnostics, an innovative global leader of in vitro diagnostics, is a subsidiary of Alere, Inc., a US publically traded company. SD specializes in creating, manufacturing, and marketing rapid test kits for diseases. Their major products include test kits for HIV, malaria, dengue fever, syphilis, and influenza.