Medical Device Link.

Originally Published IVD Technology May 2004

INDUSTRY NEWS

By clearing the OraQuick Rapid HIV antibody test by OraSure Technologies Inc. (Bethlehem, PA) for use with oral fluids, FDA has demonstrated a willingness to approve other oral-based IVDs.

The approval of a rapid HIV test for use with oral fluids may indicate more openness toward oral diagnostic tests by regulatory officials. For many years, IVD manufacturers have developed a far greater number of blood tests than oral tests. However, with greater acceptance by FDA of oral fluid tests, more IVD companies may jump into developing oral tests, which could lead to substantial growth in this market area.

OraSure Technologies Inc. (Bethlehem, PA) has received FDA approval of its OraQuick Rapid HIV antibody test for use with oral fluids. This test is the first rapid HIV test to be cleared in the United States for oral fluids application. The test was also approved for use on plasma samples.

In November 2002, the OraQuick test obtained FDA clearance for use in detecting antibodies to HIV in whole blood. The exact same test has now been cleared for use with oral fluids. According to OraSure officials, the test was originally designed for use with not only blood but also oral fluids. 

“We had developed sufficient data that would support a blood submission but hadn’t yet completed our oral fluids clinical trials,” says Sam Niedbala, PhD, chief science officer at OraSure. “The blood data were the first to come through the pipeline. So we submitted that data in part because at that time, there was a public need for a rapid HIV test.” 

OraSure officials plan to apply for waived status for the OraQuick test for use with oral fluids under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). In January 2003, the test received a CLIA waiver for use with whole blood. Company officials believe that this prior waiver will smooth the path for the new waiver.

“Getting a CLIA waiver is never an easy process,” says Niedbala. “But having the waiver for blood use creates a pathway for us. At the announcement, Health and Human Services secretary Tommy Thompson himself encouraged us to apply for a CLIA waiver. So we’re optimistic that it’s going to happen.”

OraSure’s long-term plan is to explore the possibility of having the OraQuick test for use with oral fluids sold over the counter to make it available for home use. The company did not pursue over-the-counter status for the blood test. Nonetheless, company officials said that they are inclined to apply for approval of over-the-counter sales of the oral fluids tests. Officials point to the fact that oral tests are easier for patients to conduct than blood tests.

“We plan to start by getting the oral fluids test out into the market as broadly as possible,” says Niedbala. “Then we’ll look at the response of data that are generated, and then make a judgment as to the practicality of taking it over the counter.”

The approval of this oral fluids test may have a significant effect on the oral fluids test market. By clearing this test, FDA demonstrated that it may be willing to have greater acceptance of oral tests in the future.

“Getting approval for the test for use with oral fluids is a significant change because a few years ago, there was not much understanding about how antibodies could be detected from a sample taken from the mouth,” says Niedbala. “But now, so much of that has been established because there are plenty of lab-based oral-fluid tests that occur. There’s been a huge leap forward in terms of the acceptability of oral-based diagnostics. So I see that as one of the major things that’s going to change here.” 

Niedbala added that the threshold for getting HIV tests approved is high, and FDA reviews these tests very carefully. Therefore, having approved an oral HIV test, the agency may also consider clearing oral tests for other infectious diseases for which the approval requirements are not as stringent as HIV.

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