Theranos witness says tests had gender issues

Firm gave ‘implausible’ excuse for mix ups, ex-director testifies

Theranos’ blood-testing machines were showing women with a male protein in their blood, and company founder Elizabeth Holmes gave an “implausible” excuse for the apparent errors, a former lab director testified Tuesday in Holmes’ criminal trial.

Former Theranos lab director Dr. Kingshuk Das was testifying for the prosecution in U.S. District Court in San Jose about a federal regulatory report that found deficiencies in Theranos’ testing that the regulator alleged put patients in “immediate jeopardy” of serious harm or death. Das testified that he told Holmes about women’s blood showing significant levels of prostate-specific antigen — a protein typically found only in trace elements in women — because those results provided an “easily digestible” example of Theranos’ machines “propensity” for errors. Holmes responded by providing Das with “an article or two” describing a rare phenomenon of breast cancer tumors in women producing the protein.

“It seemed implausible,” testified Das, a man with short dark hair, a charcoal suit and a blue shirt with a dark tie.

Das, who worked at Theranos for two-and-a-half years starting in late 2015, testified that nearly all of his work at Holmes’ firm involved responding to the findings of the regulator, the U.S. Centers for Medicare & Medicaid Services.

Holmes, a Stanford University dropout who founded Theranos at age 19 in 2003, is charged with allegedly bilking investors out of hundreds of millions of dollars, and defrauding doctors and patients with false claims that the company’s machines could conduct a full range of tests using just a few drops of blood. She and her co-accused, former company president Balwani, have denied the allegations. Balwani is to be tried next year.

Das’ examination of Theranos’ processes and technology led him to void all the test results — 50,000 to 60,000 of them — from the company’s ‘Edison’ blood-analyzer devices, jurors heard. When Das told Holmes about his conclusion that the devices “were

apparently malperforming from the very beginning,” she pushed back with an “alternative explanation” that the problems arose from the company’s qualityassurance processes, not its machines. Das did not believe that explanation, either, he testified. “I found these instruments to be unsuitable for clinical use,” Das said.

The former lab director also testified that Theranos issued test results without having performed the legally required daily quality control assessments on its machines, as well as after machines used for testing failed quality control repeatedly.

Under cross-examination by Holmes lawyer Lance Wade, Das acknowledged that he joined Theranos a month before the regulator’s highly critical report, and that Theranos had hired him and other laboratory experts to improve and strengthen its laboratory practices. Holmes, Das agreed, was supportive of the improvement efforts, and put no limits on what he could look at within the company.

Holmes faces maximum penalties of 20 years in prison and a $2.75 million fine if convicted, plus possible restitution, the Department of Justice has said.