Client & Alumni News

OraSure Changes the Landscape of the Diagnostic Medical Testing Market

OraSure Technologies has changed the landscape in diagnostic medical testing. Its noninvasive oral test for HIV—the first approved by the FDA—has been lauded as a key tool in the fight against AIDS.

OraSure

OraSure's products have a variety of diagnostic capabilities, ranging from HIV to other infectious diseases and drug and alcohol abuse.

The global AIDS epidemic is raging on, and OraSure’s testing technology has monumental implications for millions of people worldwide. The ease of use and speed of OraSure’s HIV test will help curb the spread of AIDS, a remarkable achievement for this former Ben Franklin Technology Partners company based in Bethlehem.

OraSure’s products have a variety of diagnostic capabilities, ranging from HIV to other infectious diseases and drug and alcohol abuse. As a leader in oral fluid testing, OraSure now supplies a variety of diagnostic tests and medical devices to public and private sector clients, life insurance companies, clinical laboratories, physicians’ offices and for workplace testing.

OraSure was founded in 1987 by Bill Hinchey, a marketing and sales executive, Mike Gausling, a corporate finance specialist, and Sam Niedbala, a research scientist. Originally called SolarCare Inc., OraSure began in the Ben Franklin Technology Partners of Northeastern Pennsylvania (BFTP/NEP) Business Incubator. The incubator has since relocated and expanded to Ben Franklin TechVentures on Lehigh University’s campus and is currently home to 24 startup companies. It has graduated 44 successful companies since 1983.

A Long-Time Partner with BFTP

OraSure received business operations assistance, strategic planning, advice and technical assistance at the BFTP incubator, allowing the business to take off. OraSure has received a total of $235,000 in investments from BFTP, starting with an initial $95,000 investment. OraSure went public in 2000 and is now traded on NASDAQ (OSUR).

With assistance from BFTP/NEP, OraSure attracted $9.1 million in outside investments including from PA Early Stage Partners. OraSure then moved into a facility located on reclaimed Bethlehem Steel brownfield sites. The industrial center was initially conceived and developed by BFTP/NEP in cooperation with the Bethlehem Economic Development Corporation, Lehigh Valley Industrial Park, Inc., Northampton County Industrial Development Corporation and Northampton County New Jobs Corporation.

OraSure shows how BFTP can leverage community and university partnerships, funding, and a network of experts and business contacts.Bob Thomson, Lehigh Valley Regional Manager for BFTP/NEP

A Legacy of Success

OraSure’s rapid growth is credited to its high level of research, innovation, the vision of the founders and the dedicated work of team members. OraSure currently has 285 employees spread over three locations.

“OraSure’s success, starting with its involvement with Ben Franklin Technology Partners more than 20 years ago, is inspiring,” says Bob Thomson, Lehigh Valley Regional Manager for BFTP/NEP. “OraSure shows how BFTP can leverage community and university partnerships, funding and a network of experts and business contacts. This is something we are proud to continue doing for startup businesses in Pennsylvania.”

In addition to HIV testing, OraSure manufactures and sells several leading cryosurgical products. This includes Histofreezer, a product for the cryosurgical removal of benign skin lesions, sold to the professional or physician office market in the United States and many foreign countries. OraSure also manufactures and sells an over-the-counter product for the cryosurgical removal of warts, available all over the world.

Looking ahead, OraSure is seeking regulatory approval to sell its OraQuick HIV test over the counter. The device is currently approved for use by clinics and hospitals. The company expects the annual U.S. market for an over-the-counter HIV test kit could exceed $500 million. OraSure is also awaiting FDA approval on the OraQuick rapid Hepatitis C test, which uses a variation of its technology to test for hepatitis. OraSure’s sales have remained strong, even in this tough economy, and the company has reported growth in 2009, which it hopes to continue into 2010.