President Bush on Friday widened his multibillion-dollar AIDS agenda and
said a Bethlehem company's quick HIV test will be key to fighting the
disease in the United States.
Bush highlighted the test made by OraSure Technologies in a White House
speech to health care professionals, African diplomats and members of AIDS
support and research groups.
He also made a surprise announcement that OraSure had been granted
permission to sell the test to about 100,000 sites across the country,
including physicians' offices and HIV counseling centers. The Food and Drug
Administration in November had approved the test for sale to only 38,000
government-approved labs.
''We must…move quickly to increase the number of people who are tested for
HIV,'' Bush said. ''How can you treat if you don't test? How can you help if
you don't know? And so the Food and Drug Administration recently has
approved a new HIV test, which can provide results in less than 30 minutes,
with a 99.6 percent accuracy.
''So today I've got an announcement to make, and it's this: that the
Department of Health and Human Services … has waived regulations so that
the test will soon be more readily available to doctors and public health
facilities throughout the country.''
OraSure's test, called OraQuick, is the first rapid HIV test to receive such
widespread clearance.
Without the waiver, OraQuick ''would be limited to use in laboratory
settings where many high-risk people do not go for testing,'' Health and
Human Services Secretary Tommy Thompson said in a news release Friday.
News of the decision was hailed by public health officials, who waited years
for a rapid test and believe OraQuick's speed will help save lives.
Most people who get an AIDS test now wait a week or more for results. At
least 8,000 people a year who test positive never return to a clinic to get
the news. So they don't start life-extending treatments and don't get
counseling on how to avoid transmitting the virus to others.
''It is a big deal,'' said Daniel C. Montoya, director of government affairs
for AIDS Project Los Angeles. ''This would allow us, out on the street, to
do counseling along with delivery of results.''
The waiver should mean stronger sales for OraSure, which employs about 130
people in Bethlehem and 200 workers total. The company will probably have to
add manufacturing workers in Bethlehem.
''It's huge for us,'' OraSure Chief Executive Michael Gausling said. ''We
all did a lot of high fives.''
OraSure stock soared after Bush's announcement, and shares closed up almost
27 percent to $7.85 on the Nasdaq stock exchange. The stock has more than
doubled since September.
The company submitted its waiver application to the FDA on Thursday. Many
analysts were startled by the approval one day later. They didn't expect a
decision for five months or more. ''By FDA standards, it's warp speed,''
Gausling said.
As part of its application, OraSure had to show that someone with a
seventh-grade education could follow the product's instructions, Gausling
said.
OraQuick is about as easy to use as a home pregnancy kit, health officials
say. To use the pocket-size OraQuick test, a health worker pricks a person's
finger, mixes a spot of blood into a vial of developing solution and drops
in the stick-like testing device.
One reddish line on the dipstick means no HIV. Two reddish lines mean the
person is probably infected and needs another test to be sure.
The fight against AIDS has become a major new policy priority for Bush. In
his State of the Union address Tuesday, he called for a sharp increase in
U.S. funds dedicated to the global battle against AIDS — to $15 billion
over the next five years.
Bush plans to focus international efforts on 14 African and Caribbean
nations with high HIV infection rates. There are 30 million HIV infected
people in Africa, including 3 million children under age 15. Of those, only
1 percent receive drug treatment.
On Friday, Bush addressed AIDS in the United States. He said he will ask
Congress for a 7 percent increase in the amount of money the nation spends
to fight AIDS. He's seeking $16 billion for the prevention and treatment of
AIDS domestically. Included are a $93 million increase for AIDS research and
an extra $100 million for a program that pays for AIDS drugs for people
lacking health coverage.
The Centers for Disease Control and Prevention in Atlanta estimates that
850,000 to 950,000 Americans are infected with HIV, including 24,000 people
in Pennsylvania and more than 800 in the Lehigh Valley. About a quarter of
those infected don't know it.
The focus on HIV testing could mean big business for OraSure, which lost
money in 2001 and in the first nine months of 2002.
''We're confident that the OraQuick line is going to grow significantly, and
that will have material impact in 2003 and beyond,'' said Aaron Lindberg, an
analyst with William Smith Special Opportunities Research in Denver.
''I think the stock is going to move higher. Our prediction is for OraSure
to turn profitable at the end of 2003 and remain so thereafter.''
OraSure's waiver for wider use comes less than three months after the FDA
initially approved the test. ''This is a great opportunity for us in terms
of the credibility of who's announcing it,'' Gausling said. ''The first FDA
approval was Tommy Thompson, and now the waiver is President Bush. It
doesn't get any better than that.''
OraSure expects at least $4 million in OraQuick sales this year as part of a
distribution agreement with Abbott Laboratories. And Gausling said OraQuick
could eventually generate annual sales between $8 million and $10 million.
Lindberg thinks sales could be much higher. He said OraSure could eventually
reap between $200 million and $600 million in sales over five years as a
result of the government's new international and domestic AIDS efforts.
Depending on how quickly demand for the OraQuick devices takes off, one of
OraSure's biggest challenges could be making the test kits fast enough.
OraQuick is made at the company's Eaton Avenue plant in Bethlehem, which
Gausling said is capable of producing 100,000 tests a month.
OraSure is running one shift at the plant, but might soon have to add a
second.
''We had the staff in place to make the initial product,'' Gausling said.
''We are at the place now of starting to add manufacturing people, and this
may accelerate that.''
Now that the whole blood version of OraQuick has cleared all regulatory
hurdles, OraSure can focus on securing FDA permission to begin clinical
trials of the saliva-based version of OraQuick. That test, which works
exactly like the blood version now on the market, is the world's only
saliva-based rapid HIV test.
However, OraSure is still perfecting that product. The company said it could
be a year or more before the saliva-based test hits the market. OraSure
currently sells a lab-based oral HIV test.
The availability of a saliva-based HIV test would be another breakthrough
because it would eliminate the need to handle blood, which can potentially
infect medical workers who are exposed to it.
Morning Call reporter Gregory Karp and The Associated Press contributed to
this story.
