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OraSure Technologies is on the Front Line in the Battle Against Ebola

By Colin McEvoy on November 25, 2015

As a widespread outbreak of the Ebola virus was ravaging West Africa, the federal government turned to a company here in the Lehigh Valley for help.

The Bethlehem-based OraSure Technologies, a national leader in point-of-care diagnostic tests and specimen collection devices, designed a rapid test to screen patients for Ebola.

“OraSure Technologies has been a pioneer in the development of rapid diagnostics in the infectious disease area,” said Douglas Michels, company president and CEO. “… We’re very excited about the future of OraSure Technologies and if history is any indication, our future’s going to be very successful and very exciting.”

OraSure Technologies exemplifies the reasons that life science research and manufacturing has been identified by the Lehigh Valley Economic Development Corporation (LVEDC) as one of the four targeted industries for the Lehigh Valley region.

The company, which graduated from a Bethlehem business incubator in its early stages, has been able to take advantage of the region’s central location, well-developed infrastructure, and strong pool of existing workforce talent.

“The Lehigh Valley’s economic history is often associated with heavy industry and manufacturing, from the days of Bethlehem Steel, but what’s often overlooked is the region’s impressive history of innovation and entrepreneurship,” said Don Cunningham, LVEDC President and CEO. “OraSure Technologies incubated on South Mountain as part of the Ben Franklin program, and has grown into a leading manufacturer in its field, with products that are sold globally.”

Earlier this year, the U.S. Department of Health and Human Services (HHS) agreed to provide up to $10.4 million to help OraSure get the OraQuick Ebola Rapid Antigen Test approved for use in countries affected by the virus.

As part of that funding, the federal government recently announced it would release $7.2 million to complete clinical testing required to request U.S. Food and Drug Administration (FDA) approval for the product to be sold in all settings, emergency and non-emergency alike.

Once that $7.2 million is exhausted, which will likely occur sometime in 2017, the company expects to receive the remaining funds to obtain additional clearances so the product can be used in physician’s offices and remote locations here in the United States, Michels said.

The test is designed to detect viral antigens in fingerstick and venous whole blood from patients presenting with signs and symptoms of Ebola infection in conjunction with epidemiological risk factors. Positive results can be read as quickly as four minutes, with negative results read in 30 minutes, which is much faster than traditional lab-based testing methods.

Typically, the product development life cycle for a similar diagnostic test can take anywhere from 3 to 5 years. But OraSure was able to demonstrate the feasibility of its test in under 90 days, and secure emergency use FDA-authorization for use in the field within 8 months.

“The company’s focus over the next several years is going to continue to be in the rapid infectious space, as well as in the expansion of our molecular collections business and possible movement into other areas of molecular diagnostics that are complementary to the work that is being done at DNA Genotek, our Ottawa, Canada-based subsidiary,” Michels said.

The Ebola tests grew out of OraSure’s technology platform for its line of rapid infectious disease tests. The company’s in-home oral HIV test is the first of its kind approved by the FDA for over-the-counter use, and has been lauded as a key tool in the fight against HIV and AIDS.

Michels said being headquartered in the Lehigh Valley has been a tremendous asset for OraSure Technologies, particularly due to its close proximity to other major metropolitan areas in the Northeast, and the excellent pool of talented workers being generated by the region’s robust educational system.

“It’s really been a privilege, an honor, and an advantage to have a technology company headquartered here in the Lehigh Valley,” he said. “The region has so many advantages over other communities across the United States. Certainly the educational institutions here provide a great benefit for companies like OraSure. We’ve really been able to source the technical talent that we need right here in the Lehigh Valley.”

OraSure Technologies was founded in 1987 and began in the Ben Franklin Technology Partners of Northeastern Pennsylvania Business Incubator in Bethlehem, where it secured seed funding very important for the company’s early development.

The company went public in 2000 and is now traded on NASDAQ. It currently operates out of two buildings in South Bethlehem, on land that had once been Bethlehem Steel brownfield sites, and has a third facility on the north side of Bethlehem.

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