Direct-to-consumer pharmacogenetic testing

19 August 2013

A new US company aims to market a $99 test for common pharmacogenetic variants.
 
The crowd-funded start-up Genome Liberty was founded following the Supreme Court ruling that gene sequences were not in themselves patentable (see previous news); the founders say that they want to provide customers with access to the most useful of their own genomic data, by indicating whether they should receive non-standard doses of certain drugs.
 
Tests will examine genetic variants of a subset of important liver enzyme genes; certain variants can affect the speed of drug metabolism for a large number of medicines; some individuals may need a much smaller dose to achieve a therapeutic effect and avoid side-effects, whilst others may need much larger doses for the drug to work.
 
The company aims to produce an iPhone app to remind you which medicines, if any, should be prescribed differently based on your genetic variants; the onus is on the consumer to share the information with clinicians. How far clinicians will engage with such information remains unknown; many may not be familiar with some of the less common pharmacogenomics variations, or have concerns about the validity and utility of data provided by the patient.
 
The regulatory environment for direct-to-consumer (DTC) genetic testing in the US also remains unclear following a decision to require regulatory approval for DTC testing under medical devices criteria. However, personalised genomics giant 23andMe – which tests for selected pharmacogenetic variants, among others - applied for approval for elements of their genotyping testing last year (see previous news).

Comment: Genome Liberty argues that information about genetic disease predisposition such as that provided by 23andMe is alarming without being actionable, whereas knowledge about your own pharmacogenetic variants has an immediate and beneficial application. The company also plans to market ‘integrated molecular self-portraits’, however, profiles of the ‘molecular and genetic dynamics of your body’, the immediate utility of which is rather less clear. 

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