OraSure Technologies Inc. (OSUR) said Tuesday a committee of the U.S. Food and Drug Administration has unanimously recommended approval of its OraQuick In-Home HIV Test. OraSure shares gained over 31 percent in after hours on the Nasdaq, following the news.
The FDA's Blood Products Advisory Committee, or BPAC, voted 17-0, in favor of OraQuick In-Home HIV Test indicating the benefits of the product outweighed risks of false positive and false negative test results.
The FDA usually considers the Committee's recommendations but is not bound to do so. If approved by the FDA, the OraQuick In-Home HIV Test will be the first-ever over-the-counter in-home HIV test.
OraSure also said the FDA Committee discussed risk mitigation strategies that should be considered in addition to the current proposed labeling.
According to the Centers for Disease Control and Prevention, despite current testing options, there are about 1.2 million people in the U.S. that have HIV and about 240,000 of them are unaware of their status.
The company said that the data presented at the BPAC included findings from the final phase of clinical testing. The company also presented a benefit analysis, using recently published research on HIV transmission rates from persons living with HIV who are aware and unaware of their infection.
According to the company, assuming 1 million individuals tested with the OraQuick In-Home HIV Test, OraSure estimates that 9,087 HIV positive individuals would be identified with the added potential to prevent more than 700 onward transmissions annually.
The OraQuick In-Home HIV Test is an over-the-counter version of the OraQuick ADVANCE Rapid HIV-1/2 Test - the first and only FDA-approved and CLIA-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in oral fluid in 20 minutes
OSUR closed Tuesday at $9.10, down $0.75 or 7.61%, on the Nasdaq. In after hours, the stock gained $2.90 or 31.87%.
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