Genetic test regulation - one size does not fit all

4 January 2011

US Commentators have expressed concern that the government should avoid overly oppressive regulation of genetic tests, including direct-to-consumer services, lest it stifle innovation.
Writing in the Health Affairs blog, Ronald Weiss emphasizes that genetic tests are not a single entity, and hence require different forms of regulation depending on their nature, purpose and application. Notably, he makes the distinction between tests administered by clinicians and those delivered direct-to-consumer, fearing that attempts to curb the latter - said to represent under 1% of all clinical laboratory testing in the US - may have an adverse impact on the former.
Joshua Lipson expresses similar concerns and notes that consumers of personal genomic testing typically ‘self-selects for education and scientific skepticism’ and does not require excessive protection. Recent surveys suggest generally high levels of satisfaction among customers (see previous news); however, this is not to say that DTC testing cannot have risks if customers fail to understand the meaning and limitations of results.

Meanwhile, one of the leading providers such testing, 23andMe, is reported to be considering new pricing structure for 2011 in an attempt to encourage new customers (see GenomeWeb). The Personal Genome Service is currently offered for US$199 plus a monthly subscription fee, a drop from an initial price of $999 when launched in 2007; last month it was on special offer at $99. This may indicate flagging consumer uptake, or attempts expand their operations into new markets. 

More from us

Genomics and policy news