Leica receives FDA Pre-Market Approval for new HER2 IHC test

[News]

Leica Biosystems, a division of Leica Microsystems, announced that it has received Pre-Market Approval from the U.S. Food and Drug Administration for the Leica Bond Oracle HER2 IHC System with the Leica BOND-MAX, establishing their commitment to developing quality companion diagnostic products.

More... (http://www.news-medical.net/news/20120426/Leica-receives-FDA-Pre-Market-Approval-for-new-HER2-IHC-test.aspx)