The Food & Drug Administration confirmed it's reviewing the kit, called Confide.
To be sold in stores for $30, Confide would include a lancet to draw blood and a smear card that would be sent to a national clinical laboratory. Users would be given the results, counseling and medical referrals by phone.
The FDA has rejected previous test kit applications, citing such concerns as packing and mailing, false positive readings and, more recently, a need for in-person medical consultations.
Confide was developed by J&J's Direct Access Diagnostics unit, formed last year. Direct's president is Elliot Millenson, an entrepreneur who designed an HIV test kit the FDA rejected in 1989.
Mr. Millenson couldn't be reached for comment last week, and no one at J&J or the FDA would comment on how long it would take for a decision.
As Edward Weiss, marketing director of research consultancy Packaged Facts, New York, noted, "it will take a large marketer-with money to spend" to get a test kit through the process.
J&J said an independent survey found 80% of gays and lesbians would be inclined to use such a test, while a recent U.S. Centers for Disease Control survey concluded "one in four Americans" would use such a test and counseling service.
J&J maintains Confide's advantages include easy access and complete anonymity. However, attention is certain to be paid to the kit's accuracy rating and post-result follow-ups.
McCann already handles self-testing kits for J&J's Advanced Care unit, including pregnancy tests and the first home cholesterol test, launching next month.
J&J has also talked with non-club agencies, including BBDO Worldwide, about the estimated $100 million Confide assignment but is now focused on its current stable. Agency executives refused to comment.