FDA Approves First at Home HIV Test

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, closed up 5.2 percent at $12.10 on Nasdaq.

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.

OraSure, on a conference call with reporters, said it expects the retail price will be slightly higher than the $17.50 it charges for professional use to account for costs associated with packaging, labeling and other support expenses.

"We expect all the major retail outlets to carry this product," Douglas Michels, OraSure's chief executive, said.

Once the product is launched, he said, the company is planning a "pretty massive effort to communicate with consumers." A direct to consumer campaign will include television, print, radio and social media advertising.

Michaels declined to provide any revenue projections for the at home version of its HIV test kit, but said it will be a significant future contributor to OraSure's top and bottom line.

He said he believes the U.S. market for in home HIV testing to be in excess of $500 million.

The FDA cautioned that a positive result from the OraQuick test 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," Michels said. "Today's FDA approval of OraQuick brings us much closer to accomplishing that goal."

The company hopes to eventually expand the availability of its home HIV test to other countries, the CEO said.