cheaper than Illumina’s and far from the comprehensive genome sequence that Illumina provides. Pathway planned to sell the kits at $20 to $30 each and charge $79 to $249 to analyze customers’ saliva for relatively few specific genetic characteristics, such as links to certain diseases or how their bodies respond to caffeine or certain prescription drugs.
Illumina’s Flatley says he sees huge opportunities for using the information that can be gleaned from a patient’s genome, adding that he thinks FDA regulators “are as excited to the possibilities as we are. I think they’re just trying to figure out the best way to make that happen, and their concerns are about the process.”
Illumina formed an internal ethics committee to study its handling of the process, and Flatley says it took roughly a year to develop internal protocols that require customers to obtain a doctor’s prescription for the genomic sequencing. The company’s protocols require that a doctor takes a patient’s sample and that results of Illumina’s genetic analysis are returned to the doctor—not the patient. “Illumina is taking the high road to make sure it’s done right,” Flatley says.
In its press release, Illumina says its process requires individuals to undergo pre-service consultation, consent and a seven-day cooling-off period.
How useful is all that information to a healthy consumer? My guess is not very, since a great deal of genetic information remains to be discovered. To Flatley, the really important stake in the ground is the special $9,500 pricing for patients with very serious, life-threatening diseases. In such cases, Flatley says sequencing a patient’s genome could be beneficial to making a diagnosis or a path for treating the disease.