PRNewswire - November 7, 2002

WASHINGTON, Nov. 7 /PRNewswire/ -- Health and Human Services Secretary Tommy Thompson today announced the Federal Drug Administration (FDA) approval of the first second-generation, 20-minute HIV test. HIV tests currently in use take one to two weeks to yield results. Public health agencies and AIDS service organizations have been eagerly awaiting the new "rapid" tests because they can be used in innovative ways to reduce the number of new infections, which currently stands at 40,000 each year.

"Each year, 8,000 HIV-infected people who come to public clinics for HIV testing do not return a week later to receive their test results," said Secretary Thompson at a Washing press conference announcing approval of the rapid test. "With this new test, in less than half an hour they can learn preliminary information about their HIV status, allowing them to get the care they need to slow the progression of their disease and to take precautionary measures to help prevent the spread of this deadly virus."

"AIDS Healthcare Foundation is proud to have spearheaded this effort and coalition in support of rapid testing," said Michael Weinstein, AIDS Healthcare Foundation's President. "This is a practical example of working through the process to get something done and we thank Tommy Thompson and the Administration for their leadership shepherding this important and potentially life-saving tool through the approval process."

While applauding the FDA for its approval of the tests, a broad, growing coalition of public health officials, health organizations, and HIV/AIDS groups are now calling for the FDA and the Centers for Medicaid and Medicare Services (CMS) to make the newly approved rapid tests widely available through a "waived" status under the Clinical Laboratories Improvement Act (CLIA).

Supporters include the President Bush's Advisory Council on HIV/AIDS (PACHA), The Congressional Black Caucus (CBC), U.S. Representatives Tom Coburn (ret.), Mike Honda and Loretta Sanchez, Earvin "Magic" Johnson, Jr., and over 100 HIV/AIDS organizations including AIDS Healthcare Foundation, AIDS Project Los Angeles, Florida AIDS Action, Gay Men's Health Crisis, the National Alliance of State and Territorial AIDS Directors (NASTAD), and the National Minority AIDS Council. Accurate, easy to use rapid tests, which will soon be approved by the FDA, yield results in twenty minutes, as opposed to current tests, which must be sent to a laboratory and take a week or longer.

"The new rapid HIV tests, if they are made widely available to family doctors and public health programs, have the potential to dramatically reduce the spread of HIV in the African American and Latino communities, which represent 74 percent of the 40,000 new infections in the U.S. each year," said U.S. Representative Loretta Sanchez (D-Anaheim). "Many high-risk individuals in these communities are not likely to seek out testing on their own, and so we must bring testing to them."

In an October 22, 2002 letter to U.S. Secretary of Health and Human Services Tommy Thompson on the subject, the Congressional Black Caucus noted, "Currently, individuals testing for HIV must wait for one to two weeks for their results ... By eliminating the waiting period, rapid testing has a vital role in Centers for Disease Control and Prevention (CDC) goals of reducing the number of HIV infections each year from 40,000 to 20,000 and ensuring that 95% of those who are infected know their status."

"58% of new HIV infections are among African Americans. Rapid tests could play a key role in reducing infections in the African American community, but only if they are available to the community," said Earvin "Magic" Johnson, Jr., HIV positive basketball superstar.

"We applaud Secretary Thompson and Deputy Secretary Claude Allen's leadership on this issue," said Clint Trout, associate director for federal government affairs at AIDS Healthcare Foundation, the nation's largest AIDS organization. "Rapid tests have the potential to revolutionize HIV prevention.

We think that the rapid test could be for prevention what protease inhibitors have been for treatment," he added. "The elimination of the week long waiting period will be the elimination of significant barriers to testing for many high-risk individuals," he added. "A CLIA waiver is the key to widespread access to rapid tests in the communities that most need them."

Although opponents claim that the higher level of federal oversight with a "moderately complex" status under CLIA is necessary to ensure the tests are performed accurately, supporters point out that every state already has testing and counseling networks that are well trained, experienced, and supervised by the states. "These tests are simple and easy to perform," said Laura Hanen, Director of Government Relations for the National Alliance of State and Territorial AIDS Directors (NASTAD). "States already heavily regulate counseling and testing programs to ensure their quality with all states requiring pre and post test counseling," she added. "States health departments have two decades of experience in HIV/AIDS counseling and testing and are ideally qualified to roll out rapid tests to the communities that need them. However, without a 'waived' status under CLIA, 90% of the states have told us they will either not be able to implement rapid tests, or will only be able to offer them on a very limited basis."

"A moderately complex classification under CLIA would add nothing to the elaborate structures of protections already present in laws and regulations in every state," said James Driscoll, Ph.D., federal affairs advisor to the National AIDS Treatment Advocacy Project (NATAP.)

"Nearly 300,000 HIV positive individuals in the United States are unaware of their status," said Trout. "CLIA waived rapid tests would offer us new and innovative ways to test and identify these individuals, so they can enter care and take steps to prevent the disease from passing to others. We applaud the FDA for approving the tests, and call on the FDA and Centers for Medicaid Services (CMS) to take the next step and designate the tests as 'waived' under CLIA."

The following organizations also support a "waived" status under CLIA for HIV "rapid" tests:

Adolescent AIDS Program, Children's Hospital at Montefiore, Africa AIDS Watch, African Services Committee, AIDS Alliance for Children Youth and Families, AIDS Community Care Team, AIDS Education Project, Department of Psychiatry, John A. Burns School of Medicine, University of Hawaii , AIDS Foundation of Chicago, AIDS Healthcare Foundation, AIDS Network of Western New York, AIDS.Org, Inc., AIDS Project Los Angeles, AIDS Research Alliance, AIDS Resources, Information, and Services of Santa Clara County, AIDS Service Center, AIDS Services Foundation, Orange County, AIDS Treatment Center at Stony Brook, New York, Albert Einstein College of Medicine, American Academy of HIV Medicine, American Public Health Association, Another Ministry Outreach, Ark of Reguge, Aunt Bee's, The Association of Maternal and Child Health Programs, Association of Nurses in AIDS Care, BASIC, Inc., Being Alive South Bay, Bienestar Human Services, California Prevention and Education Project , Catholic HIV/AIDS Ministry Archdiocese of Los Angeles, The Catalyst Foundation, Center for Women Policy Studies, The Catalyst Foundation, Charles R. Drew University of Medicine and Scientific Center for AIDS Research, Education and Services, Chicago Department of Public Health, Division of STD/HIV/AIDS, Children's AIDS Fund, The CHOW Project, Clinica Oscar Romero, The Coral Life Foundation, Critical Path AIDS Project, Duval County Health Department, State of Florida, East Bay AIDS Advocacy Foundation, East Bay AIDS Center, East Bay Community Law Center, Elizabeth Glaser Pediatric AIDS Foundation, The Family Care Network, Children's Hospital and Research Center of Oakland, Florida AIDS Action, Foundation for Research on Sexually Transmitted Diseases, Inc., Foothill AIDS Project, Gay Men's Health Crisis, Global Campaign for Microbicides, Gregory House Programs, Hands United Together, Hawaii CARES - HIV/AIDS Care Consortium, Hawaii State Department of Health, The Health Planning Council of Southwest Florida, Inc., HIV Medicine Association, Hoffmann-La Roche, Inc., Human Rights Campaign, Infectious Diseases Society of America, International AIDS Vaccine Initiative, International Gy and Lesbian Association, International Gay and Lesbian Human Rights Commission, KAIPPG International, L.A. Department of Public Health- Office of AIDS Program & Policy, L.A. Gay & Lesbian Center, Latino Commission on AIDS , Laurence A. Pagnoni & Associates, Long Island Minority AIDS Coalition, Los Angeles Shanti Foundation, Malama Pono: Kaua'i AIDS Project , The Magic Johnson Foundation, The Massachusetts Asian AIDS Prevention Project, Maui AIDS Foundation, Medical Advocates for Social Justive, Medilinks NY, Metropolitan Community Church of San Francisco, Minnesota AIDS Project, Montrose Clinic, National Alliance of State and Territorial AIDS Directors, National Association of People with AIDS, National Minority AIDS Council, Native American Community Services of Erie and Niagara Counties, Inc., New Jersey Public Health Association, New York State AIDS Advisory Council, New York State HIV Prevention Planning Group, North Coast AIDS Project, Ohio AIDS Coalition, Philadelphia Department of Public Health- AIDS Activities Coordinating Office, Project Inform, Project Return, ProjectShield, Inc., St. John's Riverside Hospital, St. Mary Medical Center CARE Program, The San Diego Lesbian, Gay, Bisexual, & Transgender (LGBT) Community Center, San Francisco AIDS Foundation, San Francisco Department of Public Health, The Sexuality Information and Education Council of the U.S., Solutions Outside the Box, Southern Africa Network of AIDS Service Organizations, Southern Tier AIDS Program, Inc., Stop AIDS Project, Tarzana Treatment Centers, Inc., T.H.E. Clinic For Women, Title II Community AIDS National Network, Treatment Action Group, UCLA Center for Clinical AIDS Research and Education, The Wall-Las Memorias, WellnessWorks Community Health Center, Western Colorado AIDS Project, Whittier Rio Hondo AIDS Project, Whitman-Walker Clinic, William F. Ryan Community Health Center, Women Organized to Respond to Life Threatening Disease

AIDS Healthcare Foundation is the US' largest provider of specialized HIV/AIDS medical care. AHF serves thousands of patients in California, New York and Florida regardless of their insurance status or ability to pay. In addition, AHF currently operates two free AIDS treatment clinics in Africa: the Ithembalabantu (Zulu for "people's hope") Clinic in KwaZulu Natal, Durban, South Africa & the Uganda Cares Healthcare Center in Masaka, Uganda. http://www.aidshealth.org .

SOURCE AIDS Healthcare Foundation

Web Site: http://www.aidshealth.org

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