Illumina Receives FDA Letter Regarding Research-Only Array
In addition to Illumina, four personal genetic testing firms received FDA letters. Alberto Gutierrez of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety told Newsweek that the claims made by the companies recently became more specific, prompting the FDA’s action. The FDA is working with the companies to resolve the issue.
Washington, DC 6/10/10—The FDA has notified Illumina that its Infinium HumanHap550 array when used as part of deCODE Genetics and 23andMe’s genetic information businesses is considered a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act. In a letter to Illumina, the FDA stated that the array requires premarket approval for clinical diagnostic use as part to these businesses “because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or function of the body.” The HumanHap550 array is labeled for sale as “research use only.” Illumina issued no comment.
