Theranos notes

Not written, just posted buy, Lou Sheehan



January 25, 2016, 1:15pm EST

Problems reported after regulators inspect Theranos lab in Newark

Enlarge Image »Theranos CEO Elizabeth Holmes

Theranos, led by founder and CEO Elizabeth Holmes, has been the target of a series of articles by the Wall Street Journal which question claims made about its blood testing technology. David Paul Morris/Bloomberg

Cromwell Schubarth
TechFlash Editor
Silicon Valley Business Journal
SILICON VALLEY—U.S. health inspectors have reportedly found serious deficiencies atTheranos Inc.’s laboratory in Newark.

The Wall Street Journal cited unnamed people it said are familiar with the matter who said the problems were discovered in an inspection by the Centers for Medicare and Medicaid Services. The company reportedly must correct the problems or risk suspension from the Medicare program.

The Palo Alto startup led by CEO Elizabeth Holmes has been on the defensive since The Journal in October wrote the first of a series of articles that question its blood test technology.

The Journal didn’t say exactly what the problems found in the inspection are but said they are more serious than when the agency previously inspected the facility in 2013. It said the results are expected to be made public soon.

A Theranos representative told The Journal the company had yet to see the CMS report cited by the newspaper.

Theranos stopped using its proprietary finger-prick technology this year for all but a blood test for herpes, something it said was done voluntarily as it sought Food and Drug Administration approval for more tests. The Journal stories, however, claim that the company was pressured to make the move by regulators.

The company was valued as high as $10 billion by its investors last year before the controversy around its technology erupted. Its backers include Draper Fisher Jurvetson, ATA Ventures and billionaire Larry Ellison’s Tako Ventures.

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Louis Sheehan
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