Advisory Panel Endorses OraSure In-Home HIV Test

An FDA advisory committee endorses OraSure’s OraQuick in-home HIV test in a unanimous vote. If approved, OraQuick would be the first OTC test for HIV that untrained users can perform entirely in the home.

The anticipated benefits of detecting more HIV cases and preventing subsequent disease transmissions by subjects using OraSure Technologies Inc.’s OraQuick in-home HIV test outweigh the potential risks of false results with the OTC product, according to FDA’s Blood Products Advisory Committee.

The panel May 15 endorsed approving OTC sales of OraQuick in a 17-0 vote, and also voted unanimously that the firm’s data provided a reasonable assurance of safety and effectiveness for the test’s intended use.

OraQuick would be the first OTC test for HIV that can be performed entirely in the home by untrained users, with the promise of further expanding public access to testing. In contrast, Home Access Health Corp.’s home HIV-1 test system, which received PMA approval in 1996, requires blood specimens to be mailed to a laboratory; results are then provided over the phone or in the mail.

OraSure says it expects to receive pre-market application approval in the coming months.

FDA requires PMAs for proposed devices that employ novel methods of treatment and are not substantially equivalent to currently marketed medical devices. A PMA is more complex and time-consuming to prepare than a 510(k), which is required for devices substantially similar to products already on the market.

The home test is an OTC version of OraSure’s currently available OraQuick Advance rapid HIV-1/2 test for professional use, which FDA approved through a waiver under the agency’s Clinical Laboratory Improvement Amendments program in 2004. The Advance model can detect antibodies to both HIV-1 and HIV-2 in oral fluid in 20 minutes (Also see "OraSure Plans To File Over-The-Counter HIV Test Application By Year End" - Pink Sheet, 15 Aug, 2011.).

While FDA reviewers raised concerns, based on OraSure’s data, about the potential for false-negative results, the panel emphasized the benefits of home testing, with the potential to further encourage testing by HIV-infected people who currently do not know their status.

According to the Centers for Disease Control and Prevention, 20% of the 1.2 million people in the U.S. living with HIV infection do not know their positive status, and about 50,000 people are infected annually.

Panel member Jay Brooks Jackson said depending on uptake, the home test has the potential to allow “thousands” of additional people to learn of their HIV-positive status. “I do think it is, overall, a positive tool that I support,” said Jackson, director of pathology at Johns Hopkins School of Medicine.

FDA sought input on whether the home test is accurate enough to merit PMA approval after OraSure’s clinical trial showed a lower rate of sensitivity (proportion of correctly identified positives) than the 95% minimal acceptable level the panel recommended previously. In briefing documents for the panel, reviewers acknowledged the value of informing unaware infected persons, but said the benefit is offset “in some measure” by false negatives.

OraSure’s unobserved, self-test study of 5,662 subjects showed specificity (proportion of correctly identified negatives) of 99.98%, but sensitivity was 92.98%. The professional-use version demonstrated 99.8% specificity and 99.3% sensitivity.

Among the agency’s concerns is that some individuals currently tested by professionals may turn to the less sensitive, but more private, OTC testing alternative should the assay be approved.

OraSure maintained in its briefing documents that even at the observed 93% sensitivity in the study, “it is possible to project a strong risk benefit [ratio for] commercial deployment of the OTC self-test” because “a significant proportion of expected users will not be testing by conventionally available means.”

The panel generally agreed. “People who are hard to reach and people who don’t enter the health care system may get through their network of friends the encouragement to get tested. And if the test is available, they will get tested,” said Alex Carballo-Diéguez, professor of clinical psychology at Columbia University Medical Center.

Members also said human error likely was the reason for the lower sensitivity rate observed in the self-test study. “I believe the difference is likely due to the fact that now we have people that don’t do these [tests] for a living,” said Francisco Rentas, director of the Armed Services Blood Program.

Data Analysis And Public Health Impact

Based on data, certain assumptions and risk-assessment modeling, FDA predicts the home test would lead to 45,000 new true positive test results in the first year and avert more than 4,000 HIV transmissions.

“The sensitivity of the test across the range that was observed in the … clinical trial does not appear to have a large impact on public health relative to some of other factors,” said Richard Forshee, associate director for research in the Center for Biologics Evaluation and Research’s Office of Biostatistics & Epidemiology.

FDA says it would expect the home test to generate one false negative result for every 13 true positive test results, about 3,800 per year; and one false positive test for every 3,750 true negative tests, about 1,100 per year.

OraSure said it would work with FDA to ensure labeling provides clear and detailed instructions for use to help mitigate the potential for incorrect results. The firm plans a website with tutorials on conducting the test, as well as educational programs.

“There are obviously more things that we can do relative to the actual support around the product to try to maximize the quality of the results that are obtained,” said Stephen Lee, OraSure’s executive VP and chief science officer.

While OraSure has not disclosed pricing for the home test, the firm lists the professional version at $17.50. Lee said he expects the home test to sell for less than Home Access’ mail-in HIV test service, listed online at $44. The firm plans to make the home test available online and at retailers with TV, print and radio spots.

Chembio Diagnostics Inc. says it also is asking FDA for a home-use test indication.

[Editor's note: This article was provided by "The Gray Sheet," Elsevier Business Intelligence's weekly newsletter on the medical device and diagnostics industries. Sign up for a free trial online, or call 1-800-332-2181 – no credit card needed.]