FDA reviewing personal genetic testing kits
FDA sent letters to four genomics companies requesting information regarding their respective personal genetic testing kits. FDA noted that the tests, which the agency said meet the definition of devices, have not been submitted for regulatory clearance or approval. The tests included in the letters are: KnomeComplete from Knome Inc. (Cambridge, Mass.), Navigenics Health Compass from Navigenics Inc. (Foster City, Calif.), deCODEme Complete Scan from deCode Genetics ehf (Reykjavik, Iceland) and 23andMe Personal Genome Service from 23andMe Inc. (Mountain View, Calif.).
FDA also sent a letter to Illumina Inc. (NASDAQ:ILMN) noting that the company's Infinium HumanHap550 Array, which is used by deCode and 23andMe in their tests, is considered a device. The agency said that although the array is designated for research use only, the company is knowingly providing the array to 23andMe and deCode for clinical diagnostic use without FDA clearance or approval. Illumina was up $1.05 to $44.99 on Friday. ...