Coonan Clinical Laboratories, Inc.
This article was originally published in The Gray Sheet
Executive Summary
Costa Mesa, California company plans to develop a home HIV test system, called HIV-1 Home Check, by which people may collect their own blood samples, submit samples by mail for screening, and receive results by telephone from trained HIV counselors. The program would also include a database for referrals to treatment locations. The system would resemble one developed by Johnson & Johnson's Direct Access Diagnostics that is undergoing premarket review at FDA ("The Gray Sheet" May 30, I&W-2)