Reports in Australian papers the Age and the Brisbane Times note the impending arrival of a newcomer to the personal genomics scene: Lumigenix, a home-grown offering cooked up by Sydney entrepreneur Romain Bonjean.
The new arrival will face several major obstacles to establishing itself in the market. Firstly, 23andMe has been offering its well-established and well-publicised service in Australia since October 3rd (announced on Twitter). There’s no obvious home-ground advantage for an industry where the service requires only a postal address and an internet connection, so Lumigenix will have to compete on an even playing field – and that’s a tough ask against an outfit as slick, professional and experienced as 23andMe. (At AU$700 = US$470, the Lumigenix test will be slightly more expensive than 23andMe’s US$399 offering.)
But perhaps more importantly, the regulatory environment in Australia is fairly forbidding for direct-to-consumer (DTC) genetic testing, especially compared to the relatively open US situation. Both articles note ominously that the Australian government actually looks set to institute a complete ban on DTC genetic testing in the not-too-distant future:
The federal bureaucracy is preparing laws for late next year — or possibly the year after — that will prohibit access to home use and direct-to-consumer genetic tests. The Therapeutic Goods Administration has government approval to proceed, and draft legislation is on the way.
The central argument is that any “in vitro diagnostic device” — which includes a website designed to interpret your DNA — that is used to diagnose a disease or test for susceptibility to disease must be in a clinical setting to ensure high-quality health care.
Both articles also quote Professor Ron Trent from Sydney University laying down the traditional line on DTC genetic testing:
“They are right, it is the future of medicine — but it’s got to be used appropriately,” he says. “These companies are allowing medical professionals to be bypassed. It’s all very well for them to advise you to get genetic counselling (afterwards), but the (test) results have very important repercussions for your health and the health of your children, brothers and sisters. DNA tests must be accompanied by the appropriate advice from a health professional.” [my emphasis]
Neither article mentions that Trent chairs a high-level committee advising the Australian government on human genetics. If this is the sort of opinion the government is hearing from its expert advisers, that doesn’t bode well for personal genomics companies looking to provide unfettered access for customers to their own genetic data.
Fortunately the article in The Age also presents an opposing viewpoint, from respected geneticist and notable contrarian Bob Williamson:
He believes the medical establishment is too uptight about giving people unfettered access to their genetic codes. “In the long run, honest information empowers people to make the right choices, while ignorance disempowers people,” he says.
“Doctors underestimate the extent to which people are able to understand complex concepts when applied to their own health and their own lives,” he says. “Many people are used to dealing with probabilities when it comes to breast cancer or lung cancer, which are partly genetic and partly environmental. You don’t need it explained by a medical professional on every occasion.”
Needless to say I find Williamson’s argument more convincing than Trent’s. My position is that allowing people free access to information about themselves should always be the default position, unless there is strong evidence to show that doing so will result in harm. At this stage there are no compelling data demonstrating that personal genomic data is likely to cause serious harm to customers, so it’s premature for regulators to shut access to the industry down.
By all means governments should introduce minimal standards to help filter out amateurish DTC genetic testing outfits (like, say, Gene Essence); but a complete ban on DTC genetic testing would be an outrageous, paternalistic and unjustified violation of the freedom of consumers to access their own genetic information.
As for Lumigenix, it remains to be seen whether this venture will succeed in the face of rigorous competition, over-zealous regulation, and an economic slowdown that will likely seriously punish sales of “luxury” goods like genome scans – but I’d say the odds aren’t good.