BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Monday November 10, 10:00 am Eastern Time
Shiloov plans to begin marketing the HIV ShiloovTube to blood banks, hospitals, clinics and diagnostic laboratories in Mexico within the next few months.
"The HIV ShiloovTube is expected to contribute significantly to the earlier and more accurate detection of HIV antibodies in donated blood samples in Mexican blood banks," said Tamar Jehuda-Cohen, Ph.D., Chairperson of Shiloov(TM) and inventor of the technology. "We believe the approval by the Mexican health authorities will help pave the way for registration of the HIV ShiloovTube throughout Latin America and the rest of the world."
Shiloov submitted to the Mexican health authorities the results of a study conducted at the Mexican Central Reference Laboratory for HIV in which diagnostic kits used in conjunction with the HIV ShiloovTube demonstrated a 25 percent increase in detection sensitivity. In the study, 200 blood samples donated by a high-risk population were tested for HIV twice: once using a conventional diagnostic test kit alone, and once using the same test kit after pre-treatment with the HIV ShiloovTube. The results indicated that 20 samples tested positive for HIV when used with the test kit alone while 25 samples tested positive when used in conjunction with the HIV ShiloovTube. Additional tests carried out on the samples that tested positive solely with the use of the HIV ShiloovTube confirmed these samples to be infected with the AIDS virus.
Shiloov has conducted similar studies in Kenya and Israel that show the HIV ShiloovTube to be capable of enabling diagnostic tests to detect blood samples contaminated with the HIV virus missed by conventional diagnostic tests alone. The results of recent studies were published in the proceedings of the American Association of Blood Banks conference that took place in October in Denver.
An estimated 10 million blood and plasma samples are tested for HIV annually in Mexico and Latin America. The current rate of worldwide testing for HIV is about 200 million blood and plasma samples annually.
The HIV ShiloovTube is under regulatory review in Brazil, Israel, South Africa, Kenya and the U.S. Shiloov expects to begin U.S. clinical trials of the HIV ShiloovTube in the beginning of 1998 and will seek expedited approval from the U.S. Food and Drug Administration (FDA).
Shiloov Medical Technologies Ltd. is dedicated to the development, manufacture and marketing of innovative, cost effective medical products designed to facilitate early diagnosis, disease control and improved patient care and outcome. Founded in 1994 with six years already invested in its revolutionary technology, Shiloov is based in Rehovot, Israel and is a privately held company. Shiloov Biotechnologies (U.S.A.) Inc. was established in mid-1997.
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