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FDA Approves OraSure's Over-The-Counter Home HIV Test
 
 
  July 3, 2012, 2:54 p.m. ET

--FDA approves first HIV test to be sold in retail stores
--Test will be available in October
--Home test appears to be not as accurate as tests by health professionals

WSJ By Jennifer Corbett Dooren

WASHINGTON--The Food and Drug Administration Tuesday approved a home HIV test that will be sold in retail stores so people wouldn't have to go to a health facility to learn if they have the virus.

The test, made by OraSure Technologies Inc. (OSUR), has been available to health-care professionals. The test, called the OraQuick In-Home HIV test, uses a mouth swab to collect saliva. The swab is then inserted into a test tube where results are made available within a 20-to-40 minute time frame.

Company officials said the test will be available in October and sold at more than 30,000 retailers such as Wal-Mart Stores Inc. (WMT) and large grocery and drug-store chains including CVS Caremark Corp. (CVS), Rite Aid Corp. (RAD) and Walgreen Co. (WAG). The test will also be sold online.

OraSure said a price hasn't been established but it will be slightly higher than the $17.50 currently paid by health-care professionals, to fund additional labeling costs and a customer-support center.

The FDA said a positive result needs to be confirmed with a follow-up test in a health-care facility. The agency also said negative readings don't necessarily mean people aren't infected with HIV because the test might not be able to pick up infections within three months before testing.

Still, the agency said the test has the potential to identify large numbers of previously undetected HIV infections, especially if used by people unlikely to use standard screening methods.

About 1.2 million people in the U.S. are infected with HIV, and about 50,000 infections are diagnosed each year, a level that has been stable for a decade. Federal health officials have estimated that 20% of people with HIV don't realize they are infected and risk spreading the virus, which causes AIDS.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," said Dr. Karen Midthun, director of FDA's Center for Biologics Evaluation and Research. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

However, there is one concern about the home test: Clinical testing has showed it doesn't appear to be as accurate as tests conducted by health professionals.

One measure of the test's accuracy in the home setting showed it had a sensitivity rate of 92%. The FDA said this means there would be one false negative test result for every 12 tests taken in HIV-infected individuals.

The FDA said one false positive result would be expected out of every 5,000 test results taken by uninfected individuals.

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Press Release

OraSure Receives FDA Approval of OraQuick(R) In-Home HIV Test

First and Only Rapid HIV Test for Over the Counter Use --- To be Available in October for Purchase Online and at Retail Stores Nationwide


BETHLEHEM, Pa., July 3, 2012 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's OraQuick® In-Home HIV Test for sale directly to consumers in the over-the-counter (OTC) market - making it the first and only rapid OTC HIV test approved in the U.S. The OraQuick® In-Home HIV Test can detect antibodies to both HIV-1 and HIV-2 with an oral swab, providing a confidential in-home testing option with results in as little as 20 minutes. It is the first rapid diagnostic test for any infectious disease that has been approved by the FDA for sale over the counter.

"Approval of the OraQuick® In-Home HIV Test represents a major breakthrough in HIV testing," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed. This new in-home rapid test - the same test doctors have used for years - will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting."

The OraQuick® In-Home HIV Test is an over-the-counter version of the Company's OraQuick ADVANCE® HIV 1/2 Antibody Test, the market leading rapid HIV test with millions of units sold to hospitals, clinics, community-based organizations and physician offices.

The OraQuick® In-Home HIV Test is expected to be available for purchase this October at more than 30,000 retail outlets throughout the country and online.

OraSure is committed to providing OraQuick® In-Home HIV customers with extensive resources and support. Each test kit includes detailed information on HIV and HIV testing, including step-by-step directions on how to use the OraQuick® In-Home HIV Test. Customers also have access to a "live" toll-free customer support center and comprehensive consumer website. The support center is staffed with bi-lingual (English/Spanish) representatives who are available by telephone (toll free 866-436-6527) to answer questions about HIV/AIDS, describe how to use the test and interpret the results, and to provide direct referral to care if needed. Support center representatives are available 24 hours a day, seven days a week, 365 days a year and will be active starting on Monday, July 9th. In addition to the support center, a comprehensive consumer website will be launched to provide access to resources and referral to follow-up counseling and medical care. The comprehensive website will launch when product is available in October.

According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.2 million people in the U.S. that have HIV and approximately 240,000 of them are unaware of their status. Those who do not know they are HIV positive are disproportionately responsible for the 50,000 new HIV infections that occur each year.

"We set out with a clear purpose - to dramatically impact the number of people getting tested for HIV nationwide," added Michels. "Today's FDA approval of OraQuick brings us much closer to accomplishing that goal."

For information about the OraQuick In-Home HIV Test, visit OraQuick.com.

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In addition, the Company is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, and commercial and industrial entities. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health.

 
 
 
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