Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
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"The patent is intended to be the first in a series of U.S. and international patents for products based on the Shiloov(TM) technology. These products are designed to improve the early detection of life-threatening infectious diseases," said Tamar Jehuda-Cohen, Ph.D., Chairperson of Shiloov and inventor of the technology. "We believe that the HIV ShiloovTube(TM) and our other products could have a significant impact on the safety of the world's blood supply."
The Shiloov(TM) technology potentially can be used in conjunction with any blood test intended to detect the presence of a viral infection. Such diagnostic tests work by detecting not the virus itself, but rather antibodies in blood samples. When an individual is exposed to HIV or another virus, the body begins to produce antibodies to fight of the infection. Unfortunately, current diagnostic tests are unable to detect the presence of infections in blood samples taken during the early stages of infection. This is because it can take up to six months for the human body to develop detectable levels of antibodies. The ShiloovTube(TM) pre-treats the blood samples, accelerating the antibody response to viral exposure and making detection possible -- even when the person donating the blood has only recently been infected.
Shiloov's first product, the HIV ShiloovTube(TM), is being studied as a blood pre-treatment device for the earlier and more accurate detection of HIV antibodies. Other blood pre-treatment products under development are for the early detection of the viruses that cause Hepatitis C (HCV) and leukemia (HTLV).
The current rate of testing for HIV, HCV and HTLV is about 500 million tests per year worldwide. Each year about 200 million blood and plasma samples are tested for HIV alone. And in the United States, about 50 million blood and plasma samples are tested for HIV annually.
"Earlier detection of HIV can reduce the risk of contaminated blood entering the blood supply, curbing the spread of AIDS. It also will enable people infected with the virus to seek earlier and more effective treatment with the many new drugs now available," Dr. Jehuda-Cohen said.
"We expect the HIV ShiloovTube(TM), if approved, to contribute significantly to public health protection. Ultimately, it may be used as a blood pre-treatment device for screening by blood banks worldwide," she added.
Shiloov expects to begin U.S. clinical trials of the HIV ShiloovTube(TM) by the end of this year. Shiloov will seek expedited approval from the U.S. Food and Drug Administration (FDA). The HIV ShiloovTube(TM) already has been licensed for use in Mexico and is under regulatory review in Israel, South Africa and Kenya.
Shiloov has conducted studies evaluating the impact of its technology on several thousand blood samples. In one of these studies, conducted with a "high-risk" population in Kenya, 513 blood samples were tested twice: once using a conventional diagnostic test kit alone, and once using the same test kit after pre-treatment with the HIV ShiloovTube(TM). The results indicated that 45 samples tested positive for HIV when used with the test kit alone while 93 samples tested positive when used in conjunction with the HIV ShiloovTube(TM). The results of this study will be presented at the conference of the American Association of Blood Banks in October in Denver, Colorado.
In another finding, a health care worker who was exposed to HIV by a prick with a contaminated syringe was detected as being HIV positive within two weeks when the HIV ShiloovTube(TM) was used. Using the conventional test alone, the worker still tested negative even five months after exposure.
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 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 (USA), Inc. was established in mid-1997.
The information in this press release may contain forward-looking statements. A number of factors could cause actual results to differ materially from the company's assumptions and expectations. All forward- looking statements are qualified by and should be considered in conjunction with such cautionary statements.
SOURCE Shiloov Medical Technologies, Ltd.
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