SmithKline will soon begin marketing OraSure, an HIV-1 test to be distributed only by physicians initially. Developed and manufactured by Beaverton, Ore.-based Epitope Corp., OraSure last December became the first home test system for HIV to be approved by the Food & Drug Administration.
The marketer has said it will seek over-the-counter status for the product, though it hasn't yet applied. Estimates of the market potential for such a product range from $100 million to $200 million.
Also, SmithKline is testing OraSure for use in screening for other conditions, such as sexually transmitted diseases and hepatitis.
OraSure collects specimens of oral fluid with a toothbrushlike device that's placed along the gum line for 2 minutes. The pad then goes into a vial and is sent to a lab for testing. The test determines whether HIV antibodies are present.
SmithKline is light on specifics when it comes to marketing plans for OraSure.
"I have more unanswered questions than answers," said Donna Sturgess, director of diagnostics products for North America at SmithKline. Ms. Sturgess brought Epitope and SmithKline together, and formed a diagnostics division whose only product at the moment is OraSure.
"It will be a useful tool, especially to reach some populations," said Sean Strub, publisher of Poz, a magazine that focuses on HIV. Mr. Strub is also a former consultant on J&J's expected kit. He was careful to stress that OraSure is a "screening" test; because of its error rate, a positive result would require a more definitive blood test to confirm presence of HIV.
Regarding false results, the FDA said in a statement that studies showed one or two positives could be missed in 100 tests and that OraSure "is not as accurate as the approved HIV-antibody tests used on blood."
Johnson & Johnson is still awaiting FDA approval for its blood-based HIV home-testing kit, Confide, with no indication from J&J or the FDA when the review will be completed (AA, May 23).
Confide, developed by the Direct Access Diagnostics unit, is expected to cost between $30 and $40.
The FDA previously rejected other marketers' test kit applications, citing concerns about consultations and false positives.
Other companies are also working on HIV testing kits, though they haven't submitted applications to the FDA yet.
"There are still some issues to be resolved by the FDA," said Scott Shevick, an analyst at Bear Stearns & Co., New York. "What SmithKline is doing makes more sense, because it currently sidesteps the ethical issues" of on-site counseling by making OraSure available only through physicians.