Clinical Trials for At-Home Hepatitis C Testing Underway; Home Access Health Anticipates Early 1999 Launch for Second Telemedicine Service.HOFFMAN ESTATES, Ill.--(BW HealthWire)--Sept. 21, 1998--Home Access Health Corporation, the leader in telemedicine providing fast and convenient at-home medical testing and consultation, has announced clinical trials are underway for an at-home Hepatitis C test using the same telemedicine technology the company developed for HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. at-home testing. On June 30th, the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approved the Home Access Health's application for an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) which cleared the way for human trials of an at-home Hepatitis C test. As with HIV, the Home Access HCV HCV abbr. hepatitis C virus HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus. at-home test will combine telephone registration/pre-test counseling, collection of a blood sample, shipping, laboratory testing, telephone results retrieval and post-test counseling. At the lab, Home Access Health will run the same tests that are used by doctors and hospitals to identify whether antibodies to Hepatitis C virus
The Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC) in Atlanta estimates that over 4.2 million Americans are infected with the Hepatitis C virus making it an epidemic that is four times larger than HIV and AIDS. Home Access Health president Richard A. Quattrocchi said the company's 24 hour a day, seven days a week "telemedicine" technology, which wasn't available at the beginning of the HIV epidemic, would address the key elements in fighting Hepatitis C. "As with HIV, the best approach to fighting Hepatitis C is getting people counseled, tested and referred for treatment, " said Quattrocchi. "Our telemedicine expertise positions Home Access Health to make a significant contribution in stopping the spread of viral Hepatitis C." Home Access Health currently markets the only at-home HIV test approved by the United States Food and Drug Administration (FDA). Home Access Express(R) (results in three days) and Home Access(R) (results in seven days) allow people to conveniently and anonymously test for HIV from the privacy of their home with test results clinically proven to be as accurate as HIV tests administered by doctors and hospitals. Data from the Home Access clinical trials has been peer reviewed and published in the American Medical Association's Archives of Internal Medicine The Archives of Internal Medicine is a bi-monthly international peer-reviewed professional medical journal published by the American Medical Association. Archives of Internal Medicine (Vol. 157, 2/10/97). Home Access HIV tests are also available by mail by calling 1 800 HIV-TEST and are carried in more than 30,000 drugstores and drug wholesale distributors throughout the US including: AmeriSource, Bindley Western, Bergen Brunswig, Brooks, Cardinal Health, CVS Corporation, Dillons, Drug Emporium, Dominicks, Duane Reade, Eckerd Drug, Farmacias El Amal Farmacias El Amal, is regional pharmacy chain operating throughout Puerto Rico. It operates more than 60 pharmacies across Puerto Rico. The chain is privately held and was founded in 1973. , Genovese, Giant Eagle, Giant Foods, Kroger, Longs Drug Stores, McKesson Drug Company, Meijer, Osco, Pharmhouse, Phar-Mor, Revco, Rite Aid, Sav-On, ShopKO, Synder, Thrifty PayLess, Vons, Walgreens, and Wal-Mart. More information about Home Access Health can be found at the website www.homeaccess.com. |
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