The defense team of Elizabeth Holmes, the former CEO of blood testing company Theranos who is on trial on fraud charges, spent much of their third day cross-examining the former director of the laboratory of Theranos, Adam Rosendorff, to talk about aptitude tests Friday.
Proficiency testing is required by federal regulations for clinical laboratories that perform blood tests. The test compares a lab’s results on particular samples with the results of other labs testing the same samples. The purpose of proficiency testing is to assess the accuracy and reliability of a laboratory’s test operations.
Aptitude testing at Theranos became an issue earlier in Holmes’ trial when lab associate Erika Cheung testified that a comparison of the results of blood tests performed on Theranos Edison machines was inconsistent with those performed on standard machines, and that the results of reruns on the Edisons were often very different from the initial results.
Respond to questions from prosecutors earlier this week, Rosendorff testified earlier that there was no formal process for performing proficiency testing on Edisons during the time he worked at the company.
Defense attorney Lance Wade methodically reviewed a multitude of documents to establish that Rosendorff was in fact involved in the preparation of standard operating procedure (SOP) for another type of proficiency test – known as protocol d alternative assessment, or AAP – to be used specifically. on Edison machines.
A PowerPoint prepared by Rosendorff’s second in command explained that the AAP was necessary because Theranos tests “do not have peer groups” and the “normal process” of aptitude tests is therefore “not appropriate. “.
Rosendorff conceded that federal regulations allow an AAP and the PowerPoint “mirrored what I wrote in the SOP.” He also admitted to telling prosecutors at pre-trial meetings that there had been “good results” using the alternate method on the Edisons. But he continued to insist that the alternate procedure was “incomplete” and “not being implemented” while he worked at Theranos.
Holmes is accused of making false and misleading statements to investors, doctors and patients about Theranos blood testing technology. If found guilty, she faces up to 20 years in prison and a $ 3 million fine.
Wade also spoke to Rosendorff about his interactions with doctors who had questions about the results of their patients using the Theranos method. In one case, Rosendorff spoke with a doctor about a patient’s testosterone results, but then ignored a request from the same doctor for a second call.
Rosendorff testified that he “became frustrated with his inability to explain the divergent results” during this period.
Wade ended the day, but not his cross-examination, by showing Rosendorff an email exchange about another doctor who questioned a patient’s lipid panel results (blood level test). cholesterol) as “inconsistent with patient history”.
Sunny Balwani, COO of Theranos, gave Rosendorff an internal channel reflecting the company’s “confidence” in its finger lipid blood tests, based on a comparison to traditional venous blood samples.
Rosendorff reported to Balwani that he called the doctor, that he was “adamant … about our rigorous validation and quality process”, that he “did not agree with any of (the doctor’s) innuendos. “And that his review of the relevant information showed that” all QC (quality control) are in order.
Balwani replied that “Some will always be skeptics … with new technology.”
The trial will continue on Tuesday.