Health and Beauty

Theranos laboratory issues posed an “fast risk” to sufferers: audit

Former Theranos CEO Elizabeth Holmes leaves after a hearing in a federal court in San Jose, California on July 17, 2019.

Stephen Lam | Reuters

SAN JOSE, CALIF. – For the past two years of Theranos, the company’s lab director Kingshuk Das has ignored his repeated complaints about serious flaws in the startups’ blood testing technology, according to CEO Elizabeth Holmes.

Das, who came to Theranos at the end of 2015 and reported directly to Holmes, took a stand on Tuesday in their fraud trial.

He recalled trying to explain the inaccuracy problems to Holmes using the example of female patients who received abnormal levels of prostate-specific antigen, or PSA, a prostate test.

“In general, there should be no PSA detectable in women,” Das said, but recalled that Holmes offered an alternative explanation by citing “an article or two” claiming that PSA results are less common in breast cancer in women could cause.

“Was this explanation satisfactory to you?” Robert Leach, an assistant US attorney, asked.

“It seemed implausible,” said Das.

Federal prosecutors allege Holmes made false and misleading statements about Theranos blood testing technology to investors, patients and doctors. Once named the next Steve Jobs, Holmes now faces up to 20 years in prison if convicted. She has pleaded not guilty in all ten wire fraud cases and two conspiracies.

Das’ testimony could prove harmful and shows that Holmes was aware that the tests were not reliable but continued to promote them. During the opening arguments and cross-examination of government witnesses, Holmes’ attorneys portrayed her as a young, naive CEO who was unaware of the inaccuracies.

That invalidated every test on the Edison devices from 2014 and 2015, and Holmes declared that “these instruments did not work from the start”.

“I tried to present it in a more understandable format,” said Das. “I remember [Holmes] Offer an alternate explanation. “This testified that Holmes told him it was not an equipment failure, but rather a quality control and quality assurance problem.

As the lab director, Das said his first job was to respond to a result of an audit by the Centers for Medicare & Medicaid Services.

In January 2016, after an on-site inspection of the Theranos laboratory, CMS sent former laboratory manager Sunil Dhawan a deficiency report. The subject read: “DEFECTS OF THE CONDITION LEVEL – IMMEDIATE DANGER.”

“The on-site survey was completed on November 20, 2015,” says the report. “As a result of the survey, it was determined that your facility does not meet all of the requirements for certification in the CLIA program.”

CMS concluded that “the poor practices of the laboratory pose an imminent threat to patient health and safety”.

Holmes attorneys fought to keep the CMS report from being presented to the jury. Your appeal was overturned by the judge. This indicated that he had discussed the issues set out in the regulatory report with Holmes and other members of his team.

That was fired from the company in 2018. His testimony will continue on Wednesday.

The trial was delayed by more than two hours due to technology issues in the courtroom. The video system that shows exhibits on screens for judges and spectators was down. An old school projector was rolled into the courtroom and the lights were dimmed to project the exhibits onto a wall across from the jury box.

“I am very embarrassed that our courtroom had these problems,” said Edward Davila, a US district court judge. “I’m sorry this shouldn’t be happening and we shouldn’t have these disruptions. We lost valuable time.”

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