BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Tuesday, 19 November 1996.
SDS has received an initial order for the tests against the contract. The remainder of the order and subsequent orders will be shipped over a 12 month period following regulatory approval of the tests in India. Fremont predicts approval by the Drug Controller of India will take place either before the end of the year or by early 1997, said SDS President Ronald Lealos. All of the clinical trials needed for approval have been completed, he said. Fremont formed a partnership with Merind Ltd., a division of Tata Pharmaceuticals, to distribute the tests. Tata Pharmaceuticals is part of the Tata conglomerate, India's largest corporation.
Health agencies such as the World Health Organization and the Harvard AIDS Institute have estimated that India may experience between two to five million cases of HIV infection by the end of the decade. SDS' inexpensive rapid tests, which require no refrigeration or lab equipment, could be a valuable tool in detecting and counseling infected individuals, perhaps decreasing the overall rate of infection.
Lealos said he expects more approvals in the near future, in countries such as China and Thailand. "Orders are already starting to flow from places like Russia, where two of our tests are approved," said Lealos. SDS recently hired a regulatory affairs director to oversee approvals overseas and in the United States. The company announced that it intends to seek FDA approval in 1997.
SDS products include Sero-Strip HIV, a serum-based HIV antibody test, and Hema-Strip HIV, an HIV antibody test that uses a drop of whole blood for analysis. Saliva-Strip HIV, which uses saliva as a diagnostic medium, is in the final stages of development. SDS is also developing a rapid test for H. pylori, an ulcer-causing bacteria. All of the tests provide results outside laboratory settings within a few minutes. The company also sells Omni-SAL, a saliva collector used for HIV testing overseas, and Omni-Swab, a collection device used for DNA testing overseas, and other diagnostic devices.
CONTACT: Saliva Diagnostic Systems Inc. Joni O'Donahue, 360/696-4800
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