Pubdate: Tue, 09 Apr 2002
Source: Morning Call (PA)
Copyright: 2002 The Morning Call Inc.
Contact:  http://www.mcall.com/
Details: http://www.mapinc.org/media/275
Author: Christian Berg

ORASURE GETS FDA STAMP FOR NEW TEST TECHNOLOGY

Use Of Drugs Can Be Detected Using Saliva; Result Takes 10 Minutes.

OraSure Technologies of Bethlehem has received federal approval for a new 
saliva drug test that can provide results to health care workers and law 
enforcement officers in 10 minutes.

The U.S. Food and Drug Administration approved OraSure's UPlink test for 
detection of opiates like heroin and morphine. Approval was based on 
studies that show UPlink provides results as accurate as OraSure's 
FDA-approved Intercept drug test, which uses saliva samples that are 
processed in a laboratory.

UPlink is the first FDA-approved oral fluid drug test that can provide 
on-the-spot results, the company said.

OraSure specializes in medical testing of saliva for drug and alcohol abuse 
and sexually transmitted diseases. Its products are marketed mainly to the 
public health, insurance and criminal justice markets.

Michael Gausling, OraSure's president and chief executive officer, called 
the FDA UPlink approval ''a giant step forward.''

''It [UPlink] is really the platform for the future of the entire 
company,'' Gausling said.

OraSure plans to seek FDA approval this summer for an UPlink test of 
cocaine, amphetamines, PCP and marijuana. Gausling said he is 
''cautiously'' optimistic that will be approved by year's end.

Dr. Sam Niedbala, OraSure's executive vice president and chief science 
officer, said FDA approval of the UPlink system to detect opiates should 
make it easier to get clearance for new tests.

''FDA clearance of the UPlink analyzer, related software, collector and 
test cassette system should streamline future approvals, not only for our 
remaining drug tests, but also for the infectious disease applications 
currently in development,'' Niedbala said.

Despite that, Gausling said OraSure won't begin full-scale production and 
marketing of the UPlink system until 2003. The rest of this year will be 
dedicated to clinical trials of the cocaine, amphetamines, PCP and 
marijuana test and the start of product trials with selected customers.

UPlink gets its name from the patented testing process it uses - Up- 
Converting Phosphor Technology (UPT). UPT helps detect drugs and diseases 
by using phosphorescent particles similar to those that are coated onto 
television screens.

OraSure and its research partners have developed phosphorescent particles 
that convert infrared light into visible light, a process known as 
''up-conversion.'' By linking those particles to antibodies that bind to 
drugs, viruses or bacteria, OraSure is able to detect their presence. The 
UPlink system includes an oral fluid sample collector, a sample cassette 
and a test device. Once the sample is collected, it is placed into the 
cassette and inserted into the testing device, which uses a laser to excite 
the phosphorescent particles.

OraSure officials believe UPlink will be a successful product in the 
workplace, health care and drug rehabilitation markets because it can 
dramatically reduce testing time and expense compared to laboratory methods.

OraSure hasn't announced a price for the UPlink equipment, but Niedbala 
said UPlink testing costs about half as much as a typical urine drug test, 
which runs between $30 and $50. More than 42 million laboratory drug tests 
are conducted each year in the United States at a cost of $1.5 billion, 
OraSure said.

OraSure was formed in September 2000 by a $255 million merger between STC 
Technologies of Bethlehem and Epitope Inc. of Beaverton, Ore.

In addition to UPlink, products include the world's only saliva HIV test 
and saliva laboratory tests for drug and alcohol abuse. The company also 
makes tests for sexually transmitted diseases and cryosurgical equipment 
for the treatment of skin lesions such as warts.

OraSure is developing technologies that could lead to introducing more 
testing products, including tests for heart disease, cancer, allergies, 
thyroid problems and DNA.

OraSure lost $3.7 million in 2001, but revenue increased 13 percent to 
$32.6 million. Gausling said he expects 2002 revenue to increase 30 percent 
to about $42 million, and he predicted OraSure should be profitable by the 
second half of the year.

OraSure employs about 225 people, including 150 in Bethlehem.

OraSure stock closed up 77 cents, or 12.7 percent, Monday to $6.84 a share 
in trading on the Nasdaq stock exchange.
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MAP posted-by: Keith Brilhart