Magazine article Drug Topics

FDA Taking Serious Look at an At-Home HIV Test

Magazine article Drug Topics

FDA Taking Serious Look at an At-Home HIV Test

Article excerpt

Johnson & Johnson Direct Access Diagnostics, Bridgewater, N.J., is hoping to roll out a "home access HIV test and counseling service," if the Food & Drug Administration approves. The FDA has agreed to an "expeditious review" of the proposed kit, according to Elliot Millenson, president of J&J's Direct Access Diagnostics.

The proposed test and service will have four components:

* Pretest counseling and an information booklet written by former surgeon general C. Everett Koop.

* A test kit with instructions and materials for obtaining and mailing a blood sample.

* HIV testing performed by a national clinical reference laboratory.

* A test result and counseling center accessed by a toll-free 800 number.

How will the test work? The consumer will use a lancet provided in the test kit to draw a few drops of blood from a finger prick onto special sample paper. The paper contains a special identification number; this number is the only way the sample is identified, so that people being tested maintain their privacy, according to the company.

Using the prepaid, preaddressed mailer that comes with the kit, the dried blood spot sample is mailed to a licensed laboratory with extensive expertise in HIV testing.

The client then calls the counseling center after seven days via a toll-free number to obtain results, counseling, and referrals to medical care if necessary.

The company said counselors will undergo an intensive training program developed jointly by the American Social Health Association, which runs the National AIDS Hotline, and Cicatelli Associates, which conducts counselor training programs for the New York State Public Health Department.

The firm believes that a home service will provide wider access to HIV testing and counseling, encouraging those who are embarrassed about going to a clinic or who do not live near a clinic to be tested. Distribution channels may include pharmacies, college health centers, and public health departments.

The service will have multilanguage and TDD (Touchtone Device for the Deaf) capabilities, so people who speak languages other than English or are hearing impaired will have access to it.

Wendy Strongin, M.D., senior v.p., research and development, DAD, pointed to a recent survey conducted by the Centers for Disease Control & Prevention, Washington, D. …

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