NextBillion - An Initiative of the William Davidson Institute at the University of Michigan

Friday, March 3, 2017

OraSure Technologies has picked up a key global health agency endorsement of its OraQuick HIV Self-Test, a critical step in expanding the market for the diagnostic tool outside the U.S., especially in developing countries.

The Global Fund’s Expert Review Panel for Diagnostics awarded OraQuick HIV Self-Test a classification that allows entities using funding from The Global Fund or UNITAID to purchase the test for 12 months while Bethlehem’s OraSure pursues World Health Organization prequalification of the test.

“We are pleased to have received the endorsement of the Global Fund’s Expert Panel,” said OraSure President and CEO Douglas A. Michels. “The classification enables government organizations implementing HIV self-test pilots and programs to access funding for the OraQuick HIV Self-Test. We expect the OraQuick HIV Self-Test to be a valuable tool in reducing HIV infection rates globally. The Global Fund’s action allows for the procurement of our test while we pursue WHO prequalification.”

International sales are a small but rapidly growing portion of OraSure’s revenue, particularly in the category of HIV testing. Revenue from the international sales of HIV tests increased a whopping 217 percent in 2016 to $1.3 million, while domestic sales fell 26 percent.