Genentech, Inc. Pushes More Diagnostic-Test Regulation

Genentech Inc. wants deeper regulation of diagnostic tests. The South San Francisco biotech powerhouse said the Food and Drug Administration should regulate laboratory-developed tests, or LDTs, that are used for in-house testing by that lab only. It also wants the FDA to immediately stop clinical labs or other companies that don’t have the science to back up claims about their LDTs’ use, effectiveness or value.
MORE ON THIS TOPIC