Whatever happened to the good old days, four or five years ago, when direct-to-consumer genomics was the hot new thing?
Remember 2008, Donna Dickenson writes in New Scientist, when the New Yorker magazine was writing about 'spit parties' and 23andMe's service was named Invention of the Year by Time magazine? Where is that industry now, after so much promise and hype-heavy press?
"Fast-forward five years," Dickenson says, and now the FDA has demanded 23andMe to stop selling its tests pending more information, the DeCODE Genetics' and Navigenics' consumer tests were discontinued, and a California woman has filed a $5 million class action lawsuit alleging false and misleading advertising.
A recent New York Times article said tests of three services found dramatically varying results, questioning the validity of the tests and their usefulness in making health-related decisions.
Well, there were always doubters, notes Dickenson, a medical ethicist at the University of London.
Even in the year of the spit party, the American Society for Clinical Oncology reported that the partial type of analysis DTC firms were offering were not clinically proven to be effective in cancer care, and in 2010 the Government
Accountability Office investigated DTC firms and found that they provide misleading information and engage in deceptive marketing.
"What impact will all of this have on 23andMe's brand strategy? The firm has tried to create a sense of solidarity, emphasizing what it called 'common interests, affinities, and passions,'" Dickenson asks.
She says that if customer trust is threatened, then the company's ambitious vision for personalized medicine will not be realized, even if the firm switches to genome or exome sequencing services.
"So, while the most consciously populist genetic testing service wrestles with its critics in the months ahead, there is a growing danger that wider public acceptance of personalized medicine in the clinical setting may also suffer in the fallout from 23andMe's woes," she writes.