Ms. Holmes, a young Stanford University dropout who speaks Mandarin, applied for her first patent before she was 20 and fearlessly commanded any room she entered. Her board was populated with former diplomats and leaders of the Senate. But an investigation published in The Wall Street Journal in October changed the narrative by raising serious concerns about whether the company’s technology actually works.
Now, after a surprise inspection last summer, the Food and Drug Administration is requiring that Theranos’s equipment and individual tests go through the regulatory process and get approval. This will determine whether its foundational technology is a reality — or, like that Ebola test, an unfulfilled grand promise.
Read Full Article »