Japan's equivalent of the U.S. FDA, the Koseisho, has licensedEmeryville, Calif.-based Chiron Corp.'s Quantiplex HCV RNA probeassays in Japan. The probes will be marketed by Chiron's Japanesepartner, Daiichi Pure Chemicals Co. Ltd. It is the first time Chironhas commercialized its DNA probe.Under an agreement signed in 1989 between Chiron and Daiichi,Daiichi agreed to provide $20 million over five years in exchange forthe right to distribute and license Chiron's bDNA-based diagnosticprobes in Japan and Taiwan. Chiron will receive a royalty on thesesales. Chiron also has an agreement with another Japanese company,Takeda Chemical Industries Ltd., which has Chiron's super oxidedisumutase drug in clinical trials as a treatment for osteoarthritis inJapan.The probe assays are based on Chiron's proprietary branched DNA(bDNA) technology, which detects and quantitates hepatitis C virus(HCV) ribonucleic acid (RNA) in blood. Chiron estimated that morethan 2 million Japanese are affected by hepatitis C, a major cause ofserious liver disease, and that Japan spends more than $1 billion ontreatment for hepatitis C each year.The bDNA probes will be used to help predict patient response tointerferon therapy and to monitor medical treatment regimens.Chiron is also developing HBV (hepatitis B virus) and HIV probes.Neither these nor the HCV probe have yet been approved for generaluse in the U.S., where they are still undergoing research testing.Chiron's probe technology is based on signal amplification. ThebDNA probes work by binding to RNA or DNA and to linking probeswhich target specific segments of the viral genome. Signal-producingmolecules consisting of alkaline phosphatase bind to the DNA andlabel each viral sequence with up to 1,000 molecules, producing lightemissions that are measured by an instrument called a luminometer._Philippa Maister

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