Illustrated by Ly Ngo.Update: The Wall Street Journalreported today that Elizabeth Holmes, Theranos' founder, may face a two-year ban from the blood-testing business for failing to fix issues at the company's Newark, CA lab.
This article was originally published on January 28, 2016.
A new government letter may confirm what many have suspected for the past few months: Theranos' Newark, CA, location is an immediate "jeopardy to patient health and safety," a notice to the company from the Centers for Medicare & Medicaid reads. Theranos now has 10 days to correct the issues and respond to the letter.
The letter cites problems with analytic systems, hematology, as well as the laboratory director, testing personnel, and technical supervisor that prevented the lab from meeting safety standards.
The company, which sells medical-lab services and aims to make diagnostic blood tests more accessible, has dealt with a fair share of criticism since October, when a Wall Street Journal report argued that its innovative needle-free blood tests aren't exactly what they seem. Since then, the FDA has found some troubling conditions at the company, including keeping poor records and lacking a system for conducting quality audits. This new notice is just the latest in a flurry of accusations that have been lobbied at Theranos recently.
In response, the company told The Vergethat the government letter referred to the state of lab "months ago" and that conditions have improved significantly since. Now, the company has 10 days to officially respond to the letter. Walgreens, one of Theranos' major partners, has already said it will stop sending tests to Theranos's Newark location.
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