OraSure Wins U.S. FDA Approval for First At-Home HIV Test

OraSure Technologies Inc. won approval for the first at-home HIV test that lets people get results without using a doctor or laboratory.

The Food and Drug Administration cleared the saliva test that offers results within 20 to 40 minutes and would be sold without a prescription, the agency said today in a statement. Sales may reach $20 million next year assuming a $40 price tag for the product from Bethlehem, Pennsylvania-based OraSure, said Caroline Corner, a senior analyst with McNicoll, Lewis & Vlak in New York, before the agency’s announcement.

About 250,000 people at risk of HIV aren’t tested. Advisers to the agency who backed the device May 15 said it may help reduce that number. About 1.2 million people in the U.S. have HIV, the virus that causes AIDS, and 20 percent of those people are unaware they are infected, according to the Centers for Disease Control and Prevention.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. “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.”

OraSure also markets the only FDA-approved rapid test that detects HIV antibodies in oral fluid and provides results in a clinic or doctor’s office. Other at-home kits, such as Home Access Health Corp.’s Express HIV Test System, require users to send blood samples to a laboratory.

‘Major Breakthrough’

“Approval of the OraQuick In-Home HIV Test represents a major breakthrough in HIV testing,” said Douglas A. Michels, president and chief executive officer of OraSure Technologies. “For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed.”

OraSure increased 5.2 percent to $12.10 at the close in New York. The company’s shares have gained 36 percent in the past 12 months.

FDA staff had raised concerns in a report May 11 that a high number of people with HIV would test negative using OraSure’s kit.

Final-phase trials of the home test confirmed 5,384 of 5,385 negative users resulting in one false positive, according to the FDA staff report. It also detected 106 of 114 confirmed positive users resulting in eight false negatives.

Test Accuracy

The test used by professionals that is on the market is 99 percent accurate at detecting those with HIV compared with a 93 percent accuracy rate for those with HIV who would test at home.

Regulators urged people who receive a positive result with the at-home kit to confirm the finding with their doctors and a laboratory-based test.

“Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months,” the agency said in its statement.

More than 16,000 people with AIDS were estimated to have died in 2008, the CDC said. About 50,000 new U.S. cases are reported a year, according to the CDC.

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