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Disruption and Regulation

Silicon Valley investors may be searching for the next company to disrupt the healthcare industry, but The Verge's Ben Popper and Elizabeth Lopatto say that investors may not be entirely cognizant of the effects of such disruption on people's lives and health.

This year, they say, revealed how some biotech companies might not be doing quite what they set out to do. For instance, Popper and Lopatto note that the Wall Street Journal's investigation of Theranos, which has been valued at some $9 billion, uncovered that the company rarely used its Edison platform to analyze its samples and might suffer from irregularities in proficiency testing.

In addition, they say that other companies like Pathway Genomics have been called out for not properly validating their tests. The US Food and Drug Administration sent a letter to the company detailing concerns about the clinical validation and marketing of the company's CancerIntercept Detect test.

Regulation, which may not be as stringent in the software fields Silicon Valley investors typically fund, slows down the pace of biotech and that, Popper and Lopatto say, may be a good thing.

"The job of slow-moving bodies like the FDA is to keep companies from harming patients in their quest to get rich," Lopatto says. "The thing is, I'm not sure Silicon Valley sees the difference."

They further argue that 23andMe's health product has been improved by the company's tussle with the US Food and Drug Administration. When 23andMe first began offering its genetic health assessment, Lopatto notes that it didn't explain the limitations of its tests, even as its breast cancer risk assessment left out the BRCA genes.

"The FDA stepped in to make the tests safer, and 23andMe is selling a better product now," Lopatto says. "Imagine if they had sold that product from the very beginning."