23andMe Giving Up on Next-Gen Sequencing

Posted in IVD by Chris Newmarker on October 27, 2016

CEO Anne Wojcicki describes it as a “hot shiny object” for her industry. But the company wants to focus on core areas for now.

Chris Newmarker

DNA23andMe—which has made a name for itself selling relatively affordable genetic tests to the masses—has halted its pursuit to create more advanced sequencing technology meant to reveal so much more about our medical predispositions.

Anne Wojcicki, the company’s CEO and co-founder, described the technology as a “hot shiny object,” but also one that is very complicated when it comes to using the information, according to media outlets, which quoted her at The Wall Street Journal’s WSJDLive 2016 global technology conference on Wednesday.

BuzzFeed News, which initially broke the story, said the Mountain View, CA, company has let go of a team of scientists that had been working on the technology.

When reached by Qmed, a company spokesperson had nothing new to add when it came to the reports. 

23andMe actually does not have much to worry about with the move, at least for now, because competitors such as Color Genomics, Helix, and Veritas Genetics are only just starting to work on advanced genomics, Jon Fingas writes in Engadget.

The possibilities of “next-generation sequencing” (NGS) are tantalizing, though. New sequencing methods developed in the past decade enabled the price of a genome to fall to $5000 in 2010, with Illumina (San Diego) announcing a $1000 genome in early 2014. Some are shooting to get it down to $20 and potentially even lower as the pace of technological progress in genomics outstrips that of even electronics.

Learn more about connected medical device innovation at BIOMEDevice San Jose, December 7–8, 2016.

Because it must pass muster with FDA over medical testing, 23andMe has had to tread carefully, however.

The company learned this lesson the hard way, too. Back in 2013, FDA slapped 23andMe with an especially scathing warning letter. FDA accused the company of providing “'health reports on 254 diseases and conditions” that could potentially cause people to make medical decisions that were not in their interests. The Silicon Valley company for a time temporarily scaled back its offering to ancestry tests, but was eventually able to roll out consumer genetic tests related to health with FDA’s blessing.

Wojcicki acknowledged at WSJDLive 2016 that the company did not fully grasp the regulatory setup, according to The Wall Street Journal. For example, it wasn’t clear to company officials that FDA regulated genetic tests to consumers, while CMS regulated genetic tests through doctors.

“You go to Silicon Valley because you want innovation, creativity. You don’t go because you want regulatory expertise,” Wojcicki said at the event, as recounted by WSJ.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[DNA image courtesy of PublicDomainPictures on Pixabay.]