FDA sends letters to genomic testing companies
On Thursday, the House Energy and Commerce Committee's subcommittee on oversight and investigations will hold a hearing to discuss direct-to-consumer personal genetic tests. FDA has already sent letters to six other companies regarding their respective personal genetic testing kits.
Interleukin Genetics Inc. (NYSE-A:ILI) and Sequenom Inc. (NASDAQ:SGNM) each received a letter. Interleukin markets its Inherent Health personal genetic test, while Sequenom markets the SEQureDx test to detect circulating cell-free nucleic acids in blood samples from pregnant women for fetal gene and chromosome abnormalities. Interleukin was off $0.02 to $0.40 on Tuesday. Sequenom was off $0.12 to $5.69.
FDA sent letters to 14 companies that market genetic testing kits notifying them that the tests do not have FDA clearance or approval. The agency requested a response within 15 days. The letters come on the second day of a public meeting to discuss FDA's forthcoming oversight of laboratory-developed tests (LDTs), which the agency has historically not regulated.
On Thursday, the House Energy and Commerce Committee's subcommittee on oversight and investigations will hold a hearing to discuss direct-to-consumer personal genetic tests. FDA has already sent letters to six other companies regarding their respective personal genetic testing kits.
Interleukin Genetics Inc. (NYSE-A:ILI) and Sequenom Inc. (NASDAQ:SGNM) each received a letter. Interleukin markets its Inherent Health personal genetic test, while Sequenom markets the SEQureDx test to detect circulating cell-free nucleic acids in blood samples from pregnant women for fetal gene and chromosome abnormalities. Interleukin was off $0.02 to $0.40 on Tuesday. Sequenom was off $0.12 to $5.69.
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