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OraSure was founded in 1988 by Sam Niedbala, Mike Gausling and two others as SolarCare Technologies Corp.
In 2000, the company merged with Epitope, a company that had developed a way of testing for HIV. After the merger, the company became OraSure.
In 2004, founder Sam Niedbala retired from the company.
In response to the COVID-19 pandemic, OraSure expanded the company by creating over 150 jobs in Bethlehem to work on creating a rapid, at-home coronavirus test. The company had previously developed products to rapidly check for Hepatitis C and Ebola.
In June 2025, healthcare entrepreneur Ron Zwanziger made an unsolicited all‑cash offer to acquire OraSure Technologies at a proposed price of between 3.50 and 4.00 dollars per share, according to people familiar with the matter. The board of OraSure rejected the approach without entering into negotiations. Zwanziger had previously attempted a stock‑for‑stock merger with the company in 2022, shortly after the appointment of chief executive Carrie Eglinton Manner, but the parties did not reach agreement on terms.