Home HIV test could spur early treatment -panel

By Susan Heavey

GAITHERSBURG, Maryland (Reuters) – An HIV test that can be
used at home and promises results in 20 minutes could help more
people get treated sooner, but raises concerns about how well
patients could cope with the test findings on their own, a U.S.
advisory panel heard on Thursday.

Testing kits that allow consumers to mail a blood sample to
a laboratory for results have been approved in the past, but
advocates said allowing people to find out their HIV status at
home makes testing easier, faster and more private.

“A number of people don’t get tested because they are
concerned about privacy,” Orasure Technology Inc. Chief
Executive Douglas Michels told Reuters at the Food and Drug
Administration panel meeting.

The company is considering seeking FDA approval for a home
version of its OraQuick test, which is already marketed to
doctors and other health-care providers.

No company has sought U.S. permission to sell the products
over-the-counter, but the FDA is asking for the panelists’
advice as it weighs how to review future proposals.

Agency officials said there were several concerns about
at-home HIV tests, including how people would cope with their
results, especially those younger than 18.

“Concerns have been expressed over the years about the
psychological effects of receiving a positive HIV test result
without the benefit of counseling. The issue that has come up
repeatedly is suicidal tendencies,” said Elliot Cowan, head of
product reviews for the FDA’s Division of Emerging and
Transfusion Transmitted Diseases.

The FDA has been grappling with possible home-use HIV tests
since 1986, when manufacturers first expressed interest in
selling mail-in kits, which have since been approved for HIV
and hepatitis C.

OraQuick would allow consumers to insert a swab of saliva
into a small bottle, providing the results while the patient
waits at home. Like home pregnancy tests, various colored lines
appear on a small window depending on whether the virus was
detected.

ENCOURAGING TESTING

The panel appeared to support marketing the test to
consumers, and told the FDA it should require over-the-counter
versions to perform almost as well as the professional ones.

“I would agree that we could probably lower the bar a
little bit for the public health good,” said panelist Thomas
Quinn, a professor of medicine at Johns Hopkins University in
Baltimore, Maryland.

Companies considering U.S. approval should conduct studies
that mimic home use, include minorities and teenagers, and
explore what happens if people use the test incorrectly, the
panelists recommended.

They should also include simple information about getting
treatment and the need to get a second test to confirm the
results, the panel said.

During the public hearing, a few opponents argued that HIV
screenings should be left to trained professionals who could
provide immediate advice.

Nearly a dozen activists and researchers said easier access
would encourage more people, especially those without access to
health care or those worried about being stigmatized, to get
tested.

Over-the-counter tests are “a must in our fight against the
spread of this disease,” said Rev. Richard Cizik, vice
president for governmental affairs at the National Association
of Evangelicals.

Orasure’s Michels said the company was working on what kind
of information to include with its test. OraQuick is effective,
but he said the company would conduct studies on how well
average people can use it before filing for approval.

The next step is for the company to meet with the agency,
he added.

He did not say what it would charge consumers, but the
professional version costs between $12 and $17.

Canada’s Medmira Inc. is also considering seeking U.S.
approval for its version, which uses a blood sample.