Illumina CEO Says Firm in Talks with FDA Regarding 'Regulatory Gray Zone' for Arrays in DTC Genomics

"What we’re working through with the FDA is how do you come up with some new paradigms that really take into account the fact that these arrays are totally different from the traditional single-analyte test where you run one clinical trial, get one result, and either approve it or not," Illumina CEO Jay Flatley said.