* First in-home HIV test sold in U.S.
* OraSure shares up 5.2 pct
* Test has 1 in 12 chance of false negative results
By Bill Berkrot and Anna Yukhananov
July 3 U.S. health regulators on Tuesday said
they approved OraSure Technologies Inc's in-home test
for HIV, making it the first over-the-counter, self-administered
test for the virus that causes AIDS.
The Food and Drug Administration gave its green light to the
OraQuick In-Home HIV Test, which within 20 to 40 minutes
provides results from an oral fluid sample taken by swabbing the
upper and lower gums inside the mouth.
Shares of the company, which were halted pending the FDA
announcement, shot up 5.2 percent in afternoon trading to
The company said the test -- already approved for use by
trained technicians -- will be available starting in October at
more than 30,000 retailers and online. The price will be set
closer to the launch date, it said.
The FDA cautioned that a positive result does not mean an
individual is definitely infected with HIV, but rather that
additional testing should be done in a medical setting to
confirm the result.
About 1.2 million people in the United States are living
with HIV infection, but one in five are not aware of it,
according to estimates from the Centers for Disease Control and
Prevention. About 50,000 new people are infected with HIV each
year, often from people who may not know they have the virus,
the FDA said.
"Knowing your status is an important factor in the effort to
prevent the spread of HIV," said Dr. Karen Midthun, director of
the FDA's Center for Biologics Evaluation and Research. "The
availability of a home-use HIV test kit provides another option
for individuals to get tested so that they can seek medical
care, if appropriate."
An FDA advisory committee of outside experts voted
unanimously in favor of the test in May, saying its ability to
prevent new HIV infections and link people to medical care and
social services outweighed the risk of false results.
Clinical trials for the test showed it was accurate 92
percent of the time in diagnosing people who had HIV -- meaning
one out of every 12 test results would be a false negative.
False negatives are of particular concern because they could
lead HIV-positive individuals to take fewer precautions, raising
the danger that they will engage in unprotected sex.
The test accurately gave a negative result for those without
HIV in 99.98 percent of cases, meaning there would be only one
false positive result out of every 5,000 tests.
"We set out with a clear purpose - to dramatically impact
the number of people getting tested for HIV nationwide," Douglas
Michels, OraSure's chief executive, said in a statement.
"Today's FDA approval of OraQuick brings us much closer to
accomplishing that goal."