BETHLEHEM, Pa. (WPVI) — A Lehigh Valley company that helped transform HIV testing is continuing its mission to improve public health through innovation and accessibility.

OraSure Technologies, based in Bethlehem, developed the first at-home HIV test approved for over-the-counter use in the United States.

The company’s 139,000-square-foot facility produces millions of diagnostic tests each year, including the oral fluid-based HIV test known as OraQuick.

“It was the first HIV test to get over-the-counter approval, and it’s saliva-based, which means you don’t have to prick a finger or take blood in order to get the results,” said Zach Wert, senior vice president of operations.

OraQuick remains the only oral fluid rapid HIV test of its kind approved for adult use in the U.S. The Food and Drug Administration first approved the test in 2002 and later authorized it for at-home use in 2012, marking a major shift in confidential testing and AIDS prevention.

During the COVID-19 pandemic, OraSure played a key role in producing rapid tests to meet global public health needs.

“We ramped up tremendously. So it was a global push to provide COVID tests to meet public health need,” Wert said.

OraSure’s origins trace back to a group of Lehigh University graduates whose vision grew into an international business focused on life-saving diagnostics.

“Our employees are really proud of what we do right here in Pennsylvania – whether it’s the tests that we create, the people that we serve, the customers that we serve, the health that we help people find their diagnosis or from the tests that we make right here,” Wert said.

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