Oracle Diagnostics Inc. announced that it has completedpreclinical trials of its saliva-based "dipstick" test for HIV andplans to introduce the diagnostic test in certain Asian andSouth American countries.

Oracle of Foster City, Calif., entered into a five-yearmanufacturing agreement with Genelabs Technologies Inc.(formerly Diagnostic Biotechnology Ltd.) of Singapore in May1992 to produce the assay. Oracle spokeswoman Joan Stein toldBioWorld that the company will help establish a manufacturingfacility in Singapore after raising capital through a privateplacement later this year.

Comparisons of the OraScreen HIV Rapid Test against WesternBlot and Elisa in vitro blood tests for HIV-1 showed that thesaliva-based diagnostic had a sensitivity and a specificity ofover 98 percent, Stein said. The testing was conducted inSingapore.

Oracle said the test takes about 15 minutes to perform and isexpected to sell for less than $10. The company plans to launchthe test in Thailand, the Philippines and Brazil. Oracle will alsopursue U.S. regulatory approval of the product after filing aninvestigational device exemption with FDA later this year. --Karl Thiel

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