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Bethlehem Company Gets Federal Authorization for its Rapid Ebola Virus Test

By Colin McEvoy on August 4, 2015

A Bethlehem-based developer and manufacturer of diagnostic tests and specimen collection devices has received a special authorization from the U.S. Food and Drug Administration (FDA) for its rapid Ebola test.

OraSure Technologies was previously approached by federal agencies to determine whether its technology for in-home HIV tests could be used to screen for the Ebola virus.

The FDA’s “Emergency Use Authorization” (EUA), announced this month, will allow the company’s Ebola test to be used in laboratories and facilities adequately equipped, trained, and capable of testing for Ebola, including treatment centers and public health clinics.

The test is designed to detect viral antigens in fingerstick and venous whole blood from patients presenting signs and symptoms of Ebola infection, in conjunction with epidemiological risk factors. Unlike other Ebola tests, it does not require blood to be drawn.

“The OraQuick Rapid Ebola Antigen Test is an easy to use, rapid test, taht we believe will be a critical tool in containing and controlling current outbreaks of the Ebola virus,” Douglas A. Michels, President and CEO of Orasure Technologies, said in a statement. “We are grateful for the FDA for working closely with us throughout the EUA process to expedite deployment of our test.”

OraSure Technologies is an excellent example of a company from one of the Lehigh Valley’s four target industry sectors: life science research and manufacturing. It was identified as a target sector by an economic development study by Garner Economics, based on the site-specific characteristics of the regional economy.

Among those characteristics were the region’s central location, well-developed transportation infrastructure, availability of adequate water and sewer lines to industrial sites, high relative proportion of residents with bachelor’s degrees in engineering, large number of post-secondary completion in biomedical science fields, and the presence of institutions like St. Luke’s University Health Network and the Lehigh Valley Health Network, among other factors.

Positive results from the OraQuick Rapid Ebola Antigen Test can be read as soon as they appear and have been observed as early as four minutes. Negative results have to be read at 30 minutes.

The EUA allows the use of OraSure’s test for the duration of the U.S. Secretary of the Department of Health and Human Services’ declaration on August 5, 2014, that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of the Ebola virus.

The test can be used at ambient temperatures (up to 104 degrees Fahrenheit), is easy to use with only two operational steps, a simple visual read, and does not require instrumentation. The test is also “shelf stable” in a wide range of storage conditions, according to OraSure.

The project has been funded in whole or in part with Federal funds from the U.S. Department of Health and Human Services.

Other innovative products by OraSure include rapid tests for the detection of antibodies to HIV and rapid hepatitis C (HCV) on the OraQuick platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse.

OraSure previously entered entered into an agreement with the biopharmaceutical company AbbVie, which agreed to pay OraSure $75 million for exclusive rights to sell its rapid hepatitis C (HCV) test through 2019. That test provides results in as little as 20 minutes, letting patients get referred for treatment immediately.

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