Former director of the Theranos lab speaks out, saying Elizabeth Holmes was ‘nervous’ amid issues of inaccurate blood tests

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Former Theranos CEO Elizabeth Holmes leaves after a hearing in federal court in San Jose, Calif., July 17, 2019. [Image courtesy of Reuters/Stephen Lam]

A former laboratory director at Theranos said during the Elizabeth Holmes federal fraud trial on Friday that the company was aware of the multiple concerns raised by doctors and employees at Theranos before the launch of Walgreens.

Adam Rosendorff, director of the Theranos lab from 2013 to late 2014, said Holmes and other senior executives were pushing him to validate tests he didn’t trust, CNBC reports. The former lab manager said he emailed Holmes in August 2013 indicating that the blood testing device was not ready for launch in Walgreens stores. He also raised issues related to laboratory training and staffing.

Rosendorff also spoke directly to Holmes, who had posted a countdown to the days to Walgreens launch on her office window, regarding specific concerns about the accuracy of three blood tests and she seemed nervous, a- he alleged.

“She wasn’t his usual quiet self. She was shaking a little. Her knee was tapping, “Rosendorff said, according to multiple media reports.” She didn’t seem surprised to me, she just looked nervous and upset.

Rosendorff’s testimony corroborates the statements of a former Theranos scientist during testimony last week that claimed Holmes also urged her to validate blood tests in order to expedite the deployment of the Edison device before the launch of Walgreens. Surekha Gangakhedhar, like Rosendorff, testified that she also raised concerns with Holmes and explained that the machines were not ready for use on patients.

Theranos reportedly overturned the results of a carbon dioxide blood test that showed inaccurate results, Rosendorff said at the trial. Prosecutor John Bostic also showed the jury emails reflecting incidents when doctors raised concerns about patients’ test results, The Mercury News reports. An internal email presented to the jury alleged that Holmes had requested that there be no mention of the testing being canceled and that incidents of healthcare providers requesting missing baking results should be attributed to the unavailable test for the samples collected.

Rosendorff brought the concerns to Holmes rather than former President and COO Sunny Balwani, as he believed it would have more of an impact since Balwani frequently dismissed the concerns, the scientist claimed. Despite the concerns, he testified that he felt the company placed more emphasis on fundraising and investor appeasement than on patient health and safety.

Holmes reportedly told Rosendorff at the meeting that Theranos could use conventional lab equipment at Walgreens instead of Edison technology rather than delay the launch, reports CNBC. He said the company modified Siemens FDA-approved machines to analyze small blood samples by making “micro-cups” to hold the samples, but the third-party machines were no longer FDA-approved once they were released. ‘they have been changed.

“You will obviously need to make sure that our micro cups and protocols / modifications are in no way visible to a representative of Siemens,” Holmes said in an email presented to the jury.

Rosendorff is expected to resume the witness stand this week.

Holmes and Theranos were once considered the next shining stars of Silicon Valley. Holmes claimed his company would revolutionize blood testing with technology capable of analyzing tiny amounts of blood and inked retail partnerships with Walgreens and Safeway. Forbes in 2015 recognized Holmes as America’s richest self-taught woman based on Theranos’ multi-billion dollar valuation at the time.

Investigative reports quickly dismantled Holmes’ tech claims, raising questions about whether she and others misled investors. The downward spiral culminated with the company shutting down in 2018, with the United States Securities and Exchange Commission accusing Holmes and Balwani of what it described as “massive fraud.”

Holmes, along with Balwani, faces 10 counts of wire fraud and two counts of conspiring to commit wire fraud over allegations that she knowingly misled investors by claiming that Theranos technology could revolutionize blood testing. They both pleaded not guilty to all counts.

Balwani’s trial is set to follow Holmes’s.

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