Testing done by Theranos, which earned an eye-popping $9 billion valuation with its promise of blood-testing through a finger prick, was bedeviled by problems that are sure to raise more questions about its results and processes, according to details in a newly released federal report.
The 121-page report, based on an inspection of Theranos' laboratory in Newark, California by the Centers for Medicare and Medicaid Services, found issues ranging from unqualified personnel to failing to keep freezers at the proper temperatures. More than one-quarter of the quality-control checks performed on Theranos' blood-testing devices produced results outside of the company's own acceptable range, The Wall Street Journal reported, citing the report.
The report may heighten concern among patients and medical providers about the high-flying biotech company, which in January was flagged by the CMS for practices that "pose immediate jeopardy to patient health and safety." In a statement issued Thursday, Theranos said that it had submitted a "plan of correction" to the agency, which is the top federal overseer of clinical labs, and vowed to do better. Whether the company will be given a second chance by patients and doctors remains to be seen.
"We've made mistakes in the past in the Newark, CA lab, but when the company was made aware of the deficiencies we have dedicated every resource to remedy those failures," Theranos spokeswoman Brooke Buchanan wrote in the statement published on the company's site.
It's unclear whether any patients had adverse outcomes or had unnecessary treatment as a result of the testing issues at the lab. The CMS and Theranos didn't immediately return requests for further comment.
The report was released just days after an independent study from the Icahn School of Medicine at Mount Sinai found that Theranos' tests were more often outside the normal range than rival testing services. Theranos disputed those findings.
Whatever the case might be, the CMS report isn't likely to inspire confidence in Theranos. According to The WSJ, the issues highlighted by the agency include:
- Running tests with unqualified personnel
- Delays of seven weeks in informing patients about flawed results
- Storing blood samples at incorrect temperatures
- Lack of proper documentation
The lab ran almost 900,000 tests a year, according to the newspaper.
"We will continue to work with CMS to ensure every issue has been fixed completely. We recognize the critical role they play in the laboratory industry, and will continue our work to implement best-in-class policies and procedures," Buchanan said in the statement.
Some health-care companies have been distancing themselves from Theranos, including the insurance company Capital BlueCross, which in January said it would stop running tests through the start-up.