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OraSure Provides Update On Substance Abuse Testing Business

Stocks in this article: OSUR

BETHLEHEM, Pa., June 25, 2014 (GLOBE NEWSWIRE) -- OraSure Technologies (Nasdaq:OSUR), a market leader in point of care diagnostics, announced today continued progress under its agreement with Thermo Fisher Scientific (Thermo Fisher) to develop and supply homogenous fully-automated oral fluid drugs of abuse assays to be used with a new version of the Company's Intercept ® oral fluid specimen collection device. The NIDA-5 panel of automated assays developed by Thermo Fisher and the new Intercept oral fluid specimen collection device are expected to launch in the domestic criminal justice and forensics markets in the fourth quarter of 2014.

As a result of this progress, OraSure has issued its final purchase order for fully-automated assays previously developed under its now terminated collaboration with Roche Diagnostics. Under the Roche Diagnostics collaboration, which was terminated in November 2013, OraSure is entitled to receive $5.5 million as a result of its submission of a final purchase order. Payment is expected to be received during the third quarter.

As a result of the $5.5 million payment expected from Roche Diagnostics, the Company is reaffirming its projected range of consolidated net revenues of $26.0 to $26.5 million and is now projecting consolidated net income of approximately $.01 to $.02 per share for the second quarter of 2014. The payment from Roche will be recorded as a reduction of the Company's operating expenses.

"The progress we have made on the development of our new Intercept ® collection device and the optimization of this device with the homogenous assays developed by Thermo Fisher, enables us to place our final purchase order with Roche," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "The anticipated launch of our new device with the Thermo Fisher assays later this year will be an important development for our substance abuse testing business."

OraSure and Thermo Fisher signed an agreement in November 2013 that will enable OraSure to provide its customers with fully-automated oral fluid assays that can be used by laboratories on their existing clinical chemistry automated analyzers, allowing oral fluid samples to be processed with the same efficiency as current fully automated urine-based drug tests. These assays will be used with OraSure's new Intercept ® collector, which features a volume indicator that activates when a sufficient oral fluid sample has been collected. This new feature is expected to better serve the future needs of OraSure's drug testing customers. Under its agreement with Thermo Fisher, OraSure will have the right to purchase and resell the assays in the U.S. and in certain foreign countries, subject to receipt of applicable regulatory approvals.

OraSure's current Intercept® Oral Fluid Drug Testing System was the first FDA-cleared in-vitro diagnostic laboratory-based oral fluid drug testing system, and is the only one that is FDA cleared for detection of nine commonly abused drugs, including marijuana, cocaine, opiates, PCP, amphetamines, methamphetamine, barbiturates, methadone and benzodiazepines. It combines the ease, efficiency, and cost savings of oral fluid collection with increased sample integrity and the accuracy of laboratory-based drug tests.

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