Validating microarray evidence

As a result of applied research conducted under the auspices of FDA’s Critical Path program by the MicroArray Quality Control (MAQC) consortium, companies could have an easier time including microarray data in their regulatory submissions.

Last week, the consortium released data that showed reproducibility of gene expression measurements across a broad swath of microarray platforms. The data represent a major step in FDA’s goal of establishing guidelines and quality control procedures for use by the agency...