SangStat Medical Corp. on Monday announced that its PRA-Statpre-transplant monitoring product has been launched inEurope by its marketing partner, Baxter Healthcare Corp. Thelaunch follows the completion of SangStat's clinical field studyof the product, the results of which are to be announced thisweek at the Eighth European Histocompatibility Conference inStrasbourg, France.
PRA-Stat is used for Panel Reactive Antibody (PRA) testing, anassay typically performed several times a year on prospectiveorgan transplant candidates to analyze the appearance anddisappearance of antibodies to human leukocyte antigens(HLA). Anti-HLA antibodies can lead to acute transplantrejection.
The device uses soluble HLA present in plasma or serum toperform histocompatibility testing by ELISA. Unlikemicrolymphocytotoxicity methods of PRA testing, the PRA-Statdoes not rely on subjective interpretation of results throughmicroscopic analysis, according to SangStat of Menlo Park, Calif.While microlymphocytotoxicity results consist of an estimate ofthe number of dead cells that result from the reaction betweenHLA and HLA antibodies, SangStat spokeswoman MariaStraatmann told BioWorld, the PRA-Stat measures the responsebetween HLA and HLA antibodies, expressed as an opticaldensity reading.
The company's blinded, multicenter U.S. and European trial ofPRA-Stat showed agreement between the test andmicrolymphocytotoxicity assay of greater than 90 percent for102 patients waiting for a variety of organ transplantscandidates, Straatmann said.
Regulatory approval was not required for marketing theproduct in Europe. The company is hoping to make a 510(k)marketing clearance to FDA in the near future, Straatmannsaid.
SangStat's stock was up 75 cents a share on Monday, closing at$8.38.
-- Karl A. Thiel Business Editor
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