) to strong buy.
Analyst Edward Tenthoff says he's confirmed from sources that the FDA will require makers of homebrew HIV genotypic resistance tests and suppliers of analyte specific reagents to seek 510(k) regulatory clearance. He expects these companies will have to cease offering HIV resistance testing services, thereby removing all current competition to TruGene HIV resistance assay. Visible Gene could have market exclusivity at launch. Tenthoff thinks the FDA's action will directly impact the company's market share next year. He is confident in his $62 million 2002 TruGene sales forecast, and has a $30 12-month price target.