Statement from Mary Vogt, President of Home Access Health Corporation, manufacturer of the Home Access HIV-1 test system, the only over-the-counter HIV test previously approved by the FDA for at-home use.
HOFFMAN ESTATES, Ill., July 3, 2012 /PRNewswire/ — “We believe that an individual’s access to HIV testing in the privacy of their own home is critical to knowing their HIV status. It’s our hope that FDA’s approval of another at-home testing option will add to the body of knowledge surrounding risk factors for HIV, increase overall testing, and reduce the rates of transmission of this dangerous virus. It’s important for those who choose to test at home to understand the options available in the marketplace and the significant differences between the accuracy of the Home Access test service that both screens and confirms preliminary positive results, and products that only screen for results and do not include confirmation testing. We believe that it’s important for consumers to have the best opportunity for accurate, complete HIV testing from home, with ready access to counseling by trained HIV professionals.”
About Home Access Health Corporation
Home Access Health Corporation (HAHC) was founded in 1993 to provide anonymous, direct-to-consumer laboratory test services using self-collected fingerstick blood. Individuals collect, package and send a small fingerstick blood specimen to the Company’s CAP-accredited laboratory, using components provided in the Home Access test kits. HAHC received FDA approval for its HIV-1 Test System in 1996 and immediately launched a national consumer awareness campaign.
In 1998, responding to the U.S. Surgeon General’s order for public health departments (and other healthcare entities) to combat Hepatitis C (HCV), the company adapted its HIV platform and fast-tracked clinical trials and regulatory filings, resulting in an FDA approval for Home Access® Hepatitis C Check test service in 1999. HAHC markets its HCV test primarily through public health departments.
In 2007, the Company received FDA clearance for its complete Cholesterol Panel, a comprehensive laboratory test system that uses self-collected fingerstick blood to measure total cholesterol, HDL-cholesterol, Triglycerides and LDL-cholesterol. The accuracy levels of the Cholesterol Panel achieve the standards established by the National Cholesterol Education Program and the test method has been certified by the CDC-sponsored National Cholesterol Reference Method Laboratory Network.
The Home Access FDA-approved test system for HIV-1 and Hepatitis C are sold directly to consumers without the need for physician intervention. (http://www.fda.gov/consumer/updates/hivtestkit012908.html). These tests are anonymous, include confirmatory testing, and access to the HAHC counseling center for results delivery, counseling, and referrals.
SOURCE Home Access Health Corporation