Theranos lab chief says Elizabeth Holmes offered ‘impossible’ explanation for odd findings – The Guardian

The former lab director of Theranos has testified that Elizabeth Holmes gave “implausible” excuses for apparent failures in the company’s tests and personally pushed back against his concerns about its signature blood testing machines.

Kingshuk Das testified on Tuesday in the high-profile case as the government heads into its 10th week of arguments against the former CEO, who faces accusations that Theranos knowingly defrauded clients and investors about its capabilities.

Speaking in the courthouse in San Jose, California, Das recounted how his discovery of unusual test results met with resistance from the Theranos founder.

In one particularly telling incident, Das said he found tests were turning up prostate-specific antigens for female patients. Holmes offered an explanation that a rare form of breast cancer could be behind the irregular results – an excuse Das said he said “seemed implausible”.

“I found these instruments to be unsuitable for clinical use,” he said of the the company’s proprietary Edison devices.

Das joined Theranos in 2016 amid mounting concerns about the company’s products, taking over as its third lab director in several years. He testified that initially his “sole responsibility” at the company was responding to a lengthy report from health regulators that found significant deficiencies in its labs.

That audit, conducted by the Centers for Medicare and Medicaid Services, found that Theranos was not in compliance with standards for lab certification and that the company lacked a process for correcting quality control issues, according to evidence presented in court on Tuesday.

Das testified that based on his findings he encouraged Holmes to void tests from the Edison devices conducted in 2014 and 2015, concluding: “These instruments were not performing from the very beginning.”

Holmes agreed to void 50,000 tests but pushed back against critiques of the devices themselves, arguing the faulty results were due to quality-control lab failures rather than inaccurate machines.

Lawyers for Holmes had fought to keep the damning report from the Centers for Medicare and Medicaid Services out of evidence but were overruled. The 121-page report came after a November 2015 audit and concluded the test deficiencies presented “a threat to patient health and safety”.

Under cross-examination by lawyers for Holmes, Das testified Theranos was working “in good faith” to improve the lab practices and that Holmes was supportive of those efforts. His testimony will continue in court on Wednesday.

Federal prosecutors have continued in week 10 of the trial to present their case against Holmes, who faces a potential sentence of 20 years in prison.

Das’s court appearance comes after testimony from two other former lab directors as well as a number of other witnesses, including the former secretary of defense and early Theranos investor James Mattis, patients who received faulty tests, and other ex-Theranos employees.

The trial is expected to run into December.