NEW YORK (GenomeWeb News) – A US congressional committee has sent a letter to consumer genomics firm 23andMe requesting more information regarding a recent mix-up in sample processing that may have lead to some customers receiving data that was not their own.
The House Committee on Energy and Commerce sent the letter today asking the firm to provide certain documents by June 28 to help with its investigation. Among the documents it seeks are internal and external communications related to the collection, processing, and analysis of the DNA samples affected by the mix-up; internal company policies, directives, and guidance materials that relate to handling such errors; and any documents from previous instances in which customers received DNA results belonging to other persons.
23andMe had informed customers of the mix-up on June 4. The firm said that it had "immediately identified all customers potentially affected, notified them of the problem and removed the data from their accounts."
According to GenomeWeb Daily News sister publication Pharmacogenomics Reporter, 23andMe had told its customers that the batch of mismatched records loaded on June 1 was due to "human error" and the "incorrect placement of a single 96-well plate used in processing samples."
Last week, the US Food and Drug Administration warned several firms, including 23andMe, that their consumer genomics services were offering diagnostic tests that have not been cleared for marketing by the agency.
In addition, the same House committee that sent 23andMe the letter today had opened an investigation last month into direct-to-consumer genomics services providers. According to the committee, the letters were prompted by "recent reports that at least one of the companies is seeking to sell personal genetic testing kits in retail locations, despite concern from the scientific community regarding the accuracy of test results."