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Theranos test gave false miscarriage diagnosis, witness testifies

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Elizabeth Holmes, founder of Theranos Inc., exits federal court in San Jose, California, on Tuesday, Aug. 31, 2021.

Getty Photos SAN JOSE (CALIF.) — Elizabeth Holmes, former CEO of Theranos Inc. testified that her blood result incorrectly indicated she suffered a miscarriage. She actually had a healthy baby.| Bloomberg | Getty Images

SAN JOSE, CALIF. — The first patient to take the stand in trial of former Theranos CEO Elizabeth Holmes said that the company’s blood test inaccurately showed she was suffering a miscarriage when in fact she had a healthy pregnancy.

Brittany Gould testified Tuesday, having miscarried twice before. She said that after discovering she was pregnant, she had taken a Theranos blood-test in September 2014.

Audra Zuchman was Gould’s nurse practitioner and she presented alarming results after reviewing Theranos’ hCG tests, which measure a pregnant hormone.

Gould, who was getting emotionally on the podium, said that Audra Zuchman had told her that her numbers were falling and she believed I was having miscarriages.

Gould miscarried after two Theranos blood tests hCG. Two and four days later, however, Gould’s pregnancy was confirmed by Quest Diagnostics tests. Her baby was healthy.

Brittany was informed by me that this looked like a unviable pregnancy. Zuchman later testified that there was no medical reason for her loss. Zuchman also stated, “There isn’t any medical explanation in pregnancy loss for value to increase from 100 back to the thousands or even to rise at all.”

Zuchman stated that she had stopped sending her patients to Theranos after filing a complaint. Zuchman recalled feeling uncomfortable about continuing her patients’ use of it as a provider.

Gould said that, after she gave birth to her son, she had never used any Theranos product. She said, “You cannot provide accurate patient treatment with incorrect results.”

Holmes, who is being charged with wire fraud and conspiring to commit wirefraud in connection to what the prosecutors describe as a multimillion-dollar scheme to defraud patients and investors, faces twelve charges. Holmes has pleaded guilty.

With the vision of revolutionizing healthcare, she was the one-time genius of Silicon Valley. She dropped out of Stanford when she was 19 years old. She promised that Theranos would run hundreds of test using just one finger-prick. John Carreyrou, a former Wall Street Journal reporter exposed how blood-testing technology failed to meet expectations in 2015.

Among the government’s next witnesses is Justin Offen, an employee from PricewaterhouseCoopers, who will testify about private text messages between Holmes and Balwani. The prosecution claimed they had 12,000 text messages between them, but only a portion will be shown to the jury.

Cross examination of former scientist

Earlier in the day, during cross examination of Surekha Gangakhedkar, a longtime senior scientist at Theranos, Holmes’ defense attorneys brought up a September 2013 email that Sunny Balwani, Theranos COO and for a time Holmes’ romantic partner, sent to her team and Holmes.

It suggested Gangakhedkar wasn’t hardworking enough.

“Please note that the software team was here till 3:07am – and is already here now at 10am…” Balwani wrote, adding that the Edison devices were “all sitting idle.”

Lance Wade of Holmes’ legal team said, “He essentially boasts [about the hours that his team worked as though it were a badge-of honor or some other thing]” in the email. He is trying to make it seem like you were not working.

“Yes,” replied Gangakhedkar.

Wade said, “And he tried to make your entire team feel guilty.”

Wade testified that she was certain.

Was Ms. Holmes criticized by Mr. Balwani? She was her supervisor. Wade asked.

This was the first witness testimony in which Holmes’ lawyers tried to shift blame towards Balwani.

Gangakhedkar spent eight years in Theranos laboratories and was directly responsible to Holmes. In 2013, she quit due to growing concerns regarding the Edison technology for blood-testing. Gangakhedkar said that Holmes repeatedly raised her concern about the accuracy of the Edison blood-testing technology and she repeated these concerns, yet he continued with Walgreens’ rollout.

You have to make mistakes in research and development before you succeed. Wade was curious.

“Yes,” Gangakhedkar said.

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