--FDA approves first HIV test to be sold in retail stores
--Test will be available in October
--Home test appears to be not as accurate as tests by health
professionals
(Adds company comments on test availability, pricing, in the
third and fourth paragraphs.)
By Jennifer Corbett Dooren
WASHINGTON--The Food and Drug Administration Tuesday approved a
home HIV test that will be sold in retail stores so people wouldn't
have to go to a health facility to learn if they have the
virus.
The test, made by OraSure Technologies Inc. (OSUR), has been
available to health-care professionals. The test, called the
OraQuick In-Home HIV test, uses a mouth swab to collect saliva. The
swab is then inserted into a test tube where results are made
available within a 20-to-40 minute time frame.
Company officials said the test will be available in October and
sold at more than 30,000 retailers such as Wal-Mart Stores Inc.
(WMT) and large grocery and drug-store chains including CVS
Caremark Corp. (CVS), Rite Aid Corp. (RAD) and Walgreen Co. (WAG).
The test will also be sold online.
OraSure said a price hasn't been established but it will be
slightly higher than the $17.50 currently paid by health-care
professionals, to fund additional labeling costs and a
customer-support center.
The FDA said a positive result needs to be confirmed with a
follow-up test in a health-care facility. The agency also said
negative readings don't necessarily mean people aren't infected
with HIV because the test might not be able to pick up infections
within three months before testing.
Still, the agency said the test has the potential to identify
large numbers of previously undetected HIV infections, especially
if used by people unlikely to use standard screening methods.
About 1.2 million people in the U.S. are infected with HIV, and
about 50,000 infections are diagnosed each year, a level that has
been stable for a decade. Federal health officials have estimated
that 20% of people with HIV don't realize they are infected and
risk spreading the virus, which causes AIDS.
"Knowing your status is an important factor in the effort to
prevent the spread of HIV," said Dr. Karen Midthun, director of
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."
However, there is one concern about the home test: Clinical
testing has showed it doesn't appear to be as accurate as tests
conducted by health professionals.
One measure of the test's accuracy in the home setting showed it
had a sensitivity rate of 92%. The FDA said this means there would
be one false negative test result for every 12 tests taken in
HIV-infected individuals.
The FDA said one false positive result would be expected out of
every 5,000 test results taken by uninfected individuals.
Write to Jennifer Corbett Dooren at
jennifer.corbett@dowjones.com.