Home Access Health Corporation A Leader in Personal Convenience Diagnostics and Healthcare Information Advisory Meeting November 3, 2005 OTC Home Use HIV Test Kits

OTC Home Use HIV Test Approved July 22, 1996 Approved July 22, 1996 PMA: BP % Sensitive, 100% Specific “Greater than 99.9% Accurate” 100% Sensitive, 100% Specific “Greater than 99.9% Accurate” Anonymous “System” Includes: Anonymous “System” Includes: –Pre-Test Counseling –Repeat Elisa –Confirmation Test (IFA) –Post-Test Counseling (English, Spanish) –Referrals

OTC HIV Rapid Test Home Access Views about Misconceptions Driving Decision to Approve: Rapid HIV Testing = Opens Floodgates to HIV Infected/Unaware Rapid HIV Testing = Opens Floodgates to HIV Infected/Unaware

OTC HIV Rapid Test Home Access Views about Misconceptions Driving Decision to Approve: Rapid HIV Testing = Opens Floodgates to HIV Infected/Unaware Rapid HIV Testing = Opens Floodgates to HIV Infected/Unaware Rapid Pregnancy Testing = Rapid HIV Testing Rapid Pregnancy Testing = Rapid HIV Testing

OTC HIV Testing Efficacy The general population doesn’t understand HIV/AIDS any better today than 10 years ago The general population doesn’t understand HIV/AIDS any better today than 10 years ago Learning that one “may be positive” for HIV is a personal CATASTROPHE, no different than 10 years ago Learning that one “may be positive” for HIV is a personal CATASTROPHE, no different than 10 years ago The moment bad news about HIV status occurs; an intensive care situation is at hand - “professional” assistance is proven and needed The moment bad news about HIV status occurs; an intensive care situation is at hand - “professional” assistance is proven and needed The living Hell of “I may be positive” critically requires systematic and timely resolution The living Hell of “I may be positive” critically requires systematic and timely resolution

OTC HIV Rapid Testing Should be approved if safety and efficacy are equal to the existing FDA-approved at-home HIV Testing service Should be approved if safety and efficacy are equal to the existing FDA-approved at-home HIV Testing service System elements “can” and should provide: System elements “can” and should provide: –Educational interaction e.g. window period –Confirmation testing –Professional “client-centered” counseling & referrals