Home >Companies >People >Elizabeth Holmes trial: Lab director raised alarms about faulty tests

Theranos Inc.’s former lab director testified Friday about what he called pervasive and persistent errors in the company’s blood-testing technology and his efforts to stop the startup from using its machines on real patients.

Adam Rosendorff, who served as lab director for the defunct blood-testing company from 2013 to 2014, said that he alerted founder and Chief Executive Officer Elizabeth Holmes to the problems with the tests but that his warnings were ignored.

“I came to believe the company cared more about PR and fundraising than patient care," said Dr. Rosendorff.

His comments capped the third week of witness testimony in the criminal fraud trial of Ms. Holmes. He is the fourth former employee to take the witness stand as federal prosecutors build their case against Ms. Holmes, who is alleged to have defrauded patients and investors with claims that her blood-testing device could diagnose more than 200 health conditions using a few drops of blood from a finger prick.

Dr. Rosendorff testified that Ms. Holmes was aware the company’s devices produced inaccurate results but pushed for Theranos to begin testing real patients. He said he left about a year and a half after joining after determining patient care wasn’t the company’s priority.

Ms. Holmes has pleaded not guilty to a dozen counts of wire fraud and conspiracy to commit wire fraud.

Upon taking the job, Dr. Rosendorff was inspired by what he called Ms. Holmes’s earnest dedication to improve patient care. He said that while he didn’t know much about the technology Theranos was building, he believed it would be innovative.

“I thought it was going to be the next Apple," he said.

Dr. Rosendorff said his impressions changed soon after joining the startup. On Aug. 29, 2013, a little over a week before Theranos was set to launch its devices for testing patients’ blood, Dr. Rosendorff sent an email to Ms. Holmes detailing how even simple tests were returning results that were way off, according to a copy of an email that was displayed in court. He said he asked for more time to address the issues and to hire more staff and improve training. He also visited Ms. Holmes’s office, where she had a paper posted to the window noting the number of days until the commercial launch.

“She was very nervous," said Dr. Rosendorff. “She was not her usual composed self." He described Ms. Holmes as trembling and her voice breaking.

In an email shown in court and dated Aug. 31, 2013, Ms. Holmes asked members of her staff how many tests had completed validation, a process required by federal regulatory guidelines before a test can be used for patient care. A staff scientist responded that none of the tests had completed validation. It was about nine days before Theranos was supposed to launch its devices for use on real patients, said Dr. Rosendorff.

Dr. Rosendorff reported to Ramesh “Sunny" Balwani, the second-in-command and Ms. Holmes’s ex-boyfriend. Dr. Rosendorff said Mr. Balwani often rebuffed his concerns or responded with hostility, so the lab director at times brought his concerns directly to Ms. Holmes because, as CEO, he thought she would be empowered to fix the problems. That didn’t happen, he said.

Theranos’s tests continued to provide inaccurate and at times highly implausible results. Dr. Rosendorff gave examples of tests for sodium and HDL, a cholesterol measurement, that were so far below the normal range for healthy individuals that he believed they were erroneous.

In certain tests, patients whose true results were higher than considered normal or healthy could show up as normal on Theranos’s tests, Dr. Rosendorff said. Those patients wouldn’t receive the treatment they needed, he said.

Theranos’s hCG test, which measured a key hormone to indicate pregnancy and the normal progression of a pregnancy, also returned erratic results, Dr. Rosendorff said.

Earlier this week, patient Brittany Gould and her nurse practitioner, Audra Zachman, testified in court that they received two test results from Theranos that indicated Ms. Gould was miscarrying when she in fact had a healthy pregnancy.

After having the same pregnancy marker tested twice more, by a different blood-testing provider, Ms. Zachman confirmed Ms. Gould still had a healthy pregnancy. Ms. Gould said she later had a baby girl.

In May 2014, Dr. Rosendorff said he worried the hCG test wasn’t fit for patient care. He sent an all-caps email to staff directing them not to release pending patient test results and to run the hormone test only on the third-party, commercial analyzers Theranos had in its lab.

Despite his directive, hCG tests continued to be run on Theranos’s propriety devices, according to court testimony.

As complaints from doctors and patients mounted, Dr. Rosendorff was tasked with fielding inquiries from physicians and providing alternative explanations for questionable results, such as a patient’s medication affecting the outcome, he said.

“I was often called upon to come up with reasons other than test performance," Dr. Rosendorff said.

Christian Holmes, Ms. Holmes’s brother who also worked at the company, was the liaison between Dr. Rosendorff and the physicians. The former lab chief testified that Mr. Holmes discussed the company’s “messaging" with him.

“At Theranos I felt pressured to defend the company’s results to physicians," Dr. Rosendorff said, adding that his superiors were “pushing me to rationalize, justify the erroneous results."

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