Theranos employees ‘slept in their cars’ to try to fix quality control issues – NBC Bay Area


The review of former Theranos lab associate Erika Cheung ended in San José on Friday as part of the federal criminal trial against Theranos founder and CEO Elizabeth Holmes.

Holmes is charged with 12 counts of wire fraud and conspiracy to commit wire fraud, based on allegedly false and misleading claims about the viability of Theranos’ blood testing technology. If convicted, Holmes faces up to 20 years in prison and a $ 3 million fine.

In cross-examination of his testimony earlier this week that Theranos’ “Edison” blood testers “frequently failed” quality control (QC) tests, Cheung agreed with defense counsel. that Theranos had implemented other QC controls, including on the mechanics of the devices themselves.

The device QCs were “a completely separate process” from the chemistry-related QC procedures performed by Cheung.

Cheung also agreed that “if QC failed, no patient samples” were analyzed on the faulty machine “until it was recalibrated.”

After further questioning by prosecutors, Cheung said the recalibration process could take up to 14 hours “if all goes well”, and longer if all did not go well, meaning employees sometimes worked backwards. back to reset machines.

“We had people sleeping in their cars because [recalibrating the machines] it was taking too long. “

Long and frequent recalibration processes have “blocked” the clinical lab workflow, meaning a patient sample “supposed to be out in two hours” could take up to three days.

Cheung said earlier this week that she makes about $ 19 an hour working for Theranos.

Also earlier this week, Cheung testified about a “warning” letter sent to him by nationally renowned trial attorney David Boies.

The letter was delivered more than a year after Cheung left Theranos by a man who waited all day in a car for her to get out of her new workplace.

The defense attorney pointed out that Cheung did not answer two phone calls from Theranos’ human resources department before the letter was sent.

After further questioning by prosecutors, Cheung said that “when I heard [the human resource director’s] voice and how scared she looked, it just reminded me how scared I was to work for this company “and” I have the right not to talk to them “.

US prosecutors then called Surekha Gangakhedkar. Gangakhedkar, a scientist who worked for Theranos for eight years, reported directly to Holmes for the past four years.

On Wednesday, the court signed an order compelling Gangakhedkar to testify and granted him immunity from future prosecution based on that testimony.

Gangakhedkar, who was the head of blood testing development, said she felt growing “pressure” and “frustration” as Theranos rushed to launch its Edison technology at Walgreens in September 2013.

Holmes has repeatedly indicated that preparing blood tests for use on the Edisons is a “top priority.”

But the Edisons and related technology weren’t cooperating.

The nanotainers in which the finger prick samples were taken could not handle the volume of blood; a thyroid function test elicited “no response” from the machines; and there were big variations and “problems getting consistent results”, all of which was “bad news” for the upcoming launch.

In meetings and emails, Gangakhedkar and his team brought these issues to Holmes’ attention.

Believing that it was not “the right decision” to “test clinical patient samples” using faulty Edison machines, Gangakhedkar quit before the launch of Walgreens.

When she met Holmes and then submitted her resignation letter to Holmes in early September, Holmes told Gangakhedkar that the launch will use traditional venous prints, not finger pricks, until the Edisons are working.

This explanation did not satisfy Gangakhedkar, who felt that “all the hard work” that she and her team had done to develop tests based on the finger prick method “was going to be wasted,” because now they were shouted “whatever happens”.

Gangakhedkar’s cross-examination will continue on Tuesday.

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