Business Wire - Thursday, June 3, 1999
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 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, 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; hepatitis, prostate and colorectal cancer, 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" 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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CONTACT: Creative Connection Public Relations, Pompano Beach Debra Lapierre Phone: 954/968-0115 E-Mail: debral@creativeconnection.com
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