The beady eye of DNA regulators needs to fall on paternity testing
THE genetics revolution has progressed at breakneck speed since the discovery of the structure of DNA and regulators have often struggled to keep up.
It has been a few years since the 鈥減ersonal genomics鈥� industry took off, and the US Food and Drug Administration is only now warning firms that genome scans are 鈥渕edical devices鈥� that require approval.
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New 杏吧原创 is all for sensible regulation to protect consumers. But as this week鈥檚 investigation into a prenatal paternity test reveals (see 鈥淭he danger of unreliable paternity tests鈥�), regulators might be focusing on the wrong part of the genetics testing industry.
聯As this week鈥檚 investigation into a prenatal paternity test reveals, regulators鈥� focus may need to change聰
There is scant evidence that the personal genomics services that have triggered these regulatory concerns have caused significant harm 鈥� and even hints that they may encourage healthy behaviour. But paternity testing is much more widely used, and the results can have life-altering consequences. What if a woman decides to terminate a pregnancy based on such results? Surely such a decision should never have to be based on a flawed DNA test result.
A robust regulatory framework is urgently required. While the sale of unreliable tests could fall foul of trading-standards rules, it is unclear whether general consumer protection agencies have the expertise needed to police the industry.
Bringing in the necessary laws should not be difficult. In most countries, labs that provide legal evidence on paternity must submit to accreditation.
In England and Wales, this is provided by the ; in the US, by the . Membership of such programmes, and associated proficiency testing, should be made mandatory for any company that is offering paternity tests.
The more general lesson is that regulators need to be more nimble, and focus on the biggest potential harms.
Many people don鈥檛 necessarily want to be 鈥減rotected鈥� from the information that lies in their own genomes. But when seeking answers to fundamental questions of paternity, they do want assurance that they can rely on the accuracy of the results.