In launching its personal genome service today here at the Consumer Genetics conference, Illumina announced that it will charge $48,000 to analyze patients DNA by whole-genome sequencing. Customers can then sign up with DTC genomic testing partners to get more information on how their genes tie in with medical outcomes.
Unlike most DTC genomic-firms, which allow customers to order gene scans over the Internet and receive sample collection kits in the mail, Illumina’s service will require a prescription from their doctor or from a physician in its Personal Genome Network.
The industry standards issued last December by 23andMe, Decode, and Navigenics are "a good start, but they are really not where they need to be," said Muin Khoury, director of the CDC's Office of Public Health Genomics.
Citing the FDA's handling of KRAS testing for anti-EGFR monoclonal antibodies, the report asserts that in the near term complex genetic tests such as Oncotype DX should be "performed through CLIA labs, and not held up by slow regulatory processes."