Impact of Advances in DNA Sequencing Technology on Genetic Diagnostic Testing
By Kevin E. Noonan –
Dr. Ellen Jorgensen of Genspace, one of the witnesses at the U.S. Patent and Trademark Office’s first hearing regarding the advisability of permitting “second opinions” for patented genetic diagnostic tests without patent infringement liability, advocated “at-home” or “do-it-yourself” DNA testing as a solution (see “USPTO Holds First Hearing on ‘Second Opinion’ Genetic Testing“). This proposal raises a significant number of questions, particularly with regard to the potential for harm to the public due to errors that might arise from such “at-home” genetic diagnostic testing or whether precautions in interpreting results would be taken concerning the emotional consequences of finding a genetic mutation in an individual’s BRCA genes.
However, the saliency of any technical objections to the idea must be considered to be significantly reduced by an announcement from Oxford Nanopore Technologies at the Advances in Genome Biology and Technology Conference at Marco Island, FL last week: a disposable gene sequencing machine the size of a standard USB thumb drive and capable of providing a complete genomic sequence for about $900. Terming the business model for the device “pay-as-you-go” sequencing, the chief technology officer of the company, Clive G. Brown stated that the new device eliminates the need for expensive ($50,000 – $750,000) machines currently in use for gene sequencing, and touted the use of the device for bedside genetic testing, biological field work, and food safety (e.g., for identifying
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