Americare Health Scan Reports on FDA Status of Ana-Sal HIV Test.MIAMI--(BW HealthWire)-- June 3, 1999-Americare Health Scan Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB:AMIT) has issued a statement clarifying the status of its non-invasive HIV test HIV test Various tests have been used to detect HIV and production of antibodies thereto; some HTs shown below are no longer actively used, but are listed for completeness and context. See HIV, Immunoblot. , the Ana-Sal(R) saliva test kit. "The company has not yet applied for approval from the U.S. Food and Drug Administration to distribute the test in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. ," said Dr. Joseph P. D'Angelo, founder and president of Americare Health Scan. An earlier news release contained language that could have been misunderstood, Dr. D'Angelo explained. The press release, which announced news completely unrelated to 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. approval, contained a passage describing Americare Health Scan and the general nature of its business. In that passage, the release stated the company was "awaiting FDA approval before making the product available in the United States." "Some readers may have misunderstood that to mean that we have filed an application for FDA approval, but that is not the case," said Dr. D'Angelo. "Although we have begun compiling the documentation that is needed, we have not submitted any application to the agency, and we did not intend to give the impression that we had. We were merely trying to make it clear that we do not yet have FDA approval to market the Ana-Sal test kit in the United States, and that we will not distribute it until we do." Dr. D'Angelo pointed out that earlier releases from the company had stated the Ana-Sal kit's status more clearly, saying that it "may soon be presented to the FDA for U.S. approval." The Ana-Sal HIV test has been approved for use in a number of other countries. Painless, quick and completely noninvasive, it relies on a saliva sample to test for exposure to 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. , the virus that causes AIDS, and has produced results that were 99.18 percent consistent with conventional blood tests. Americare Health Scan, Inc. is a leading developer of non-invasive health screening and medical diagnostic technology. In addition to the Ana-Sal HIV test kit, the company has also developed technology for detection of peptic ulcers Peptic ulcers Wounds in the stomach and duodenum caused by stomach acid and the bacterium Helicobacter pylori. Mentioned in: Tube Compression of the Esophagus and Stomach ; hepatitis, prostate and colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. , pregnancy, substance abuse, and non-invasive monitoring of blood sugar levels. For more information contact Dr. Joseph P. D'Angelo, president, at 305-770-1141. Information in this release, including any information incorporated by reference herein, includes "forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. " within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, and is subject to the safe-harbor created by such sections. The company's actual results may differ significantly from the results discussed in such forward-looking statements. Readers are cautioned that these statements are not guarantees of future performance and that actual results might differ materially from those suggested or projected in the forward-looking statements. |
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