Originally Published IVD Technology January/February 2003
INDUSTRY NEWS
Rapid HIV test obtains FDA approval |
| The OraQuick Rapid HIV-1 Antibody Test, developed by OraSure Technologies Inc. (Bethlehem, PA) was recently approved by FDA. The test detects HIV antibodies in fingerstick whole-blood samples with high sensitivity and specificity in 20 minutes. |
OraSure Technologies Inc. (Bethlehem, PA) has received FDA approval to manufacture and market its OraQuick Rapid HIV-1 antibody test, a point-of-care test designed to detect HIV antibodies in fingerstick wholeblood samples within 20 minutes. According to data submitted to FDA, the test has sensitivity of 99.6% and specificity of 100% in clinical studies performed with blood specimens.
"We are very pleased to receive FDA approval for our rapid, point-of-care HIV-1 test," says Mike Gausling, OraSure's chief executive officer. "OraQuick represents an important milestone for the company as we continue to build our leadership position in the point-of-care market."
Under a coexclusive agreement, OraSure will jointly distribute the OraQuick test with Abbott Laboratories (Abbott Park, IL). The two companies expect to roll out approximately 50,000 units of the test within the next couple of months.
"Our collaboration with OraSure will ensure that this technology is made widely available to the healthcare professionals and patients who need it," says Ed Michael, vice president, immunoassay and clinical chemistry, Abbott Laboratories.
According to OraSure officials, the company will initially market the OraQuick test to the nearly 40,000 qualified locations that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderately complex diagnostic tests. In order to allow more laboratories and other healthcare professionals to conduct the test, the company is planning to apply for waived status under CLIA, something which the government is encouraging them to do.
"I strongly urge OraSure to apply for a CLIA waiver," said Health and Human Services secretary Tommy G. Thompson. "If FDA finds that the company's data proves that the OraQuick test is both easy and safe to use, it can get a CLIA waiver. Then the test could be given in many more healthcare settings, perhaps even administered by social workers in HIV counseling centers."
OraSure officials said the company has already initiated the process to get the OraQuick test CLIA-waived.
"We're pursuing the CLIA waiver by doing our trial work right now," says Sam Niedbala, chief scientific officer at OraSure. "But first we had to get a protocol approved by FDA, so we'll be getting our application in with the data as quickly as we can."
If the OraQuick test gets CLIA-waived, OraSure will then determine whether to take the next step and try to make the test available for home use.
"From our perspective, we first have to see how the product is working on such a large population base," says Niedbala. "There are obviously concerns that people have about going over-the-counter because if people misinterpret or don't understand the results, then that can have all kinds of ramifications."
Industry analysts agree with Secretary Thompson, that the OraQuick test could have a positive effect in the public health sector. With approximately 17 million HIV tests conducted each year in the United States, analysts believe many people who need to be tested may be inclined to use a rapid HIV test rather than a standard laboratory test. Analysts also feel that with such a test, public health organizations may start HIV outreach programs in conjunction with licensed laboratories.
Moreover, analysts believe that this test could have important consequences on the ability to reduce HIV infections. One of the biggest hurdles in combating HIV has been the time that individuals have to wait for their test results. Public health clinics often are able to get people in and get their blood drawn, but they are lost to that clinic because they do not come back later for the results.
"This product has a niche in the public health arena, being able to get out into the communities, test people for HIV, get the results back to those individuals while they are still there, and initiate any necessary counseling," says Mark Sanborn, PhD, global scientific affairs manager for infectious disease at Abbott Laboratories. "Because this is a single-use test, it's designed as more of a point-of-testing– type situation."
Other areas in which the OraQuick test could be useful include emergency rooms to test patients coming in so that doctors would know whether an individual is HIV positive. The test may have use in prisons and jails where people are being processed; officials would want to get test results back quickly before they move inmates to somewhere else and data are possibly lost in the system. The assay also has potential in the military with rapid deployment forces, and the military could use such a test in combat situations.
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