), a provider of medical devices and technologies to diagnose
critical medical conditions, recently announced the availability of
its OraQuick in-home HIV test at retail outlets and online, across
The company gained the approval of the U.S. Food and Drug
Administration (FDA) for the OraQuick HIV test in the second
quarter of 2012. It is the first ever oral HIV test to be made
available directly to consumers for in-home use. The in-home test
is an over-the-counter version of OraQuick Advance which identifies
HIV-1 and HIV-2 antibodies with an oral swab. In the professional
market, OraSure has sold more than 25 million units of the tests.
The OraQuick in-home HIV test has been made available across the
U.S. at more than 30,000 retail outlets. Along with
) among others, OraSure has extended its association with large
wholesalers such as
On its second quarter conference call, OraSure had said that it
expects the test to be available at a retail price of $39. However,
the company noted that the final price will be determined by the
According to Centers for Disease Control and Prevention, almost 1.2
million Americans are infected with HIV. Out of the infected
population, 240,000 remain oblivious of their HIV status. This
ignorance has led to an additional 50,000 new HIV infections each
year. The nationwide availability of OraQuick in-home HIV test is a
quantum leap in the fight against HIV and AIDS.
The U.S. market size for an in-home HIV test is estimated at
roughly $500 million, annually. Given the sizeable market
opportunity, OraSure is expected to bolster revenues from its
infectious disease tests in the domestic market. The revenues from
infectious disease testing decreased 8% year over year to $10.4
million (55% of total revenues), due to a decline in OraQuick sales
in the most recent quarter. Revenues from domestic OraQuick HIV
test sales dipped 16% year over year to $8.4 million.
In the end, the projected selling price for the OraQuick in-home
HIV test and its acceptance by the high-risk target consumers could
affect the commercial success of the product. Additionally,
government funding will continue to affect OraSure's performance in
the public health market.
We currently have a 'Neutral' recommendation on OraSure, which
carries a Zacks #3 Rank (short-term 'Hold' rating).
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