As a Theranos insider and whistleblower, Tyler Schultz was able to provide information about the ongoing failures in medical laboratory testing at the once-high-flying Theranos to regulators and at least one journalist
What’s it like to be a whistleblower in a high-profile clinical laboratory? Few clinical laboratory workers will ever know. But former Theranos employee Tyler Shultz does know, after helping to expose the Silicon Valley blood-testing startup’s deceptions.
The 31-year-old Shultz reportedly celebrated the news of former Theranos CEO Elizabeth Holmes’ conviction on four charges of defrauding investors with champagne, joy, and a healthy dose of vindication, according to NPR.
“This story has been unfolding for pretty much my entire adult life,” Tyler Shultz (above), whistleblower in the Elizabeth Holmes fraud trial, told NPR from his parents’ home in Silicon Valley. “All of a sudden, it was just a weight was lifted. It’s over. I can’t believe it’s over,” he added. A former employee of now defunct clinical laboratory company Theranos, Shultz is CEO at Flux Biosciences, a company he co-founded. (Photo copyright: Deanne Fitzmaurice/NPR.)
Shultz Interns Briefly at Theranos
In 2011, Shultz was a biology major at Stanford University—where Elizabeth Holmes herself briefly attended—when his grandfather, former US Secretary of State George Shultz, a Theranos board member, introduced him to Holmes.
According to NPR, the younger Shultz was so impressed by the charismatic Holmes that he asked her if he could intern with Theranos after his junior year. Following his internship, he accepted a full-time position as a research engineer with Theranos, a stint that lasted only eight months. Shultz quit Theranos the day after he emailed Holmes in 2014 to alert her to failed quality-control checks and other troubling practices within the company’s clinical laboratory.
According a 2016 profile of Shultz in The Wall Street Journal (WSJ), his email to Holmes resulted in a “blistering” reply from then-Theranos President and COO Ramesh “Sunny” Balwani, who “belittled Shultz’s grasp of basic mathematics and his knowledge of laboratory science.”
Yet, Shultz told NPR, “It was clear that there was an open secret within Theranos that this technology simply didn’t exist.”
After leaving Theranos, Shultz became a key source for the WSJ’s 2015 exposé of Theranos. Using an alias, he also contacted state regulators in New York about the Theranos Edison blood-testing device’s shortcomings. In response, Theranos responded with threats of lawsuits and intimidation, the WSJ reported.
In an interview with CBS News, Shultz said, “I am happy that she was found guilty of these crimes and I feel like I got my vindication from that, and I feel good about that.”
Whistleblowers Were Critical to WSJ’s Investigation
Former WSJ reporter John Carreyrou, who authored the newspaper’s investigative series into Theranos, credits the Theranos whistleblowers for blowing the cover on the clinical lab company’s deceptions.
“I would not have been able to break this story without Rosendorff, Tyler, and Erika,” Carreyrou told NPR, referring to Shultz and two additional Theranos whistleblowers: one-time Theranos Laboratory Director Adam Rosendorff and laboratory associate Erika Cheung. “Tyler and Erika were corroborating sources, and that was absolutely critical.”
In the interview with CBS News, Tyler described the damage his role as a Theranos whistleblower caused to his relationship with his grandfather, former Secretary of State and Theranos board member George Shultz. Tyler said the elder Shultz did not believe his claims about Theranos’ regulatory deficiencies and the Edison device’s shortcomings until he neared the end of his life.
“That was extremely tough. This whole saga has taken a financial, emotional, and social toll on my relationships. The toll it took on my grandfather’s relationship was probably the worst. It is tough to explain. I had a few very honest conversations with him,” Shultz told CBS News.
While the elder Shultz never apologized to his grandson, Tyler said his grandfather ultimately acknowledged he was right.
“In one of my last conversations with him he told me a story about how he got Elizabeth invited during fleet week in San Francisco to go give a speech to United States Navy sailors. He said with tears in her eyes, she told the room about how she was so honored and humbled that her life’s work would be saving the lives of United States servicemen and women,” Shultz recalled in the CBS News interview.
“He said he could not believe that anybody could get in front of these men and women who are willing to put their lives in front of our country and lie directly to their face as convincingly as she lied,” he added.
George Shultz died in February 2021.
Jury’s Ruling on Defrauding Patients
In an interview with CNBC, Shultz said his one disappointment with the verdict was that Holmes was not found guilty of defrauding patients. Calling the patients “the real victims,” Shultz said, “I did what I did. I stuck my neck out to protect those patients, not to protect Betsy DeVos’ $100 million investment.” (The jury voted Holmes guilty on three counts of wire fraud and one count of conspiracy to commit fraud against Theranos’ investors, but not guilty on conspiracy to defraud and commit wire fraud against Theranos patients.)
Tyler Shultz was listed as a potential witness in the Holmes trial but was not called to take the stand. He—along with many clinical laboratory directors and pathologists who have closely followed the Holmes trial—will now await news of Holmes’ sentencing. Holmes could face up to 20 years in prison for each guilty verdict, but she’s likely to receive a lighter sentence.
The trail of Ramesh Balwani is expected to begin sometime in March. That trial can be expected to produce additional revelations about the problems of Theranos and how and why management is alleged to have knowingly reported inaccurate clinical laboratory test results to thousands of patients.
Jurors are expected to hear closing arguments beginning on December 16 and then will decide Holmes’ fate in criminal fraud trial
It was seven days of testimony from former Theranos CEO Elizabeth Holmes, reported in detail by most major news outlets. The jury in her criminal fraud trial heard the once-high-flying Silicon Valley executive attempt to explain away charges of deception. She acknowledged that she made mistakes while leading the clinical laboratory blood-testing company but claimed that others were ultimately responsible for the company’s failures.
Rosendorff left Theranos in November 2014. He was followed by three more Theranos laboratory directors, all of whom have testified in the fraud case against Holmes.
Presumably, in her testimony, Holmes was laying the blame for key failures in the accuracy of the lab tests performed for patients, along with major deficiencies in how her medical lab company complied with CLIA regulations, on these former Theranos laboratory directors (as the clinical laboratory company’s CLIA lab directors of record during those years).
“Whether you have an intent to defraud is really a state of mind,” she said.
The illustration above depicts ex-Theranos CEO and founder Elizabeth Holmes concluding seven days of testimony in her criminal fraud trial in San Jose, California. Closing arguments are scheduled to begin December 16. Clinical laboratory directors and pathologists following the fraud trail may soon learn whether the four clinical laboratory directors who worked for Theranos may in some way be held accountable for some of the company’s activities. (Graphic copyright: Vicki Behringer/The Wall Street Journal.)
‘We Wanted to Help People’
Holmes’ testimony may have both helped and hurt her case. According to The Wall Street Journal (WSJ), Holmes “hasn’t flinched during questioning by her lawyer or the government.
“The persona of the confident yet traumatized chief executive could create reasonable doubt in the minds of jurors, legal observers following the trial say, and muddy the evidence prosecutors put forward over 11 weeks to prove she intended to defraud investors and patients about the reach of Theranos’ technology,” the WSJ wrote.
During testimony, Holmes maintained that her goal in founding Theranos was to increase access to healthcare. “We wanted to help people who were scared of needles,” she told jurors, the WSJ reported.
In building its case, prosecutors presented witness testimony and other evidence strongly suggesting Holmes lied to investors about Theranos’ laboratory testing capabilities and deployment, concealed its use of commercial blood testing machines, and hid ongoing issues with its Edison device.
One of the most damaging moments of Holmes’ own testimony may have been when she admitted to affixing the logos of pharmaceutical giants Pfizer and Schering-Plough to reports sent to Walgreens and potential investors.
Holmes told jurors that her intent was to give credit to others, not to deceive and her defense attorneys attempted to show that many of Holmes’ more questionable decisions were aimed at protecting Theranos trade secrets.
“We had a huge amount of invention that was happening in our laboratories,” Holmes testified, according to CNN’s trial coverage. “We had teams of scientists and engineers that were working really hard on coming up with new ideas for patents and trade secrets, and we needed to figure out how to protect them.”
Holmes Claims No Responsibility for Theranos’ Lab Operations and Product Development
On the witness stand, Holmes acknowledged she was the final decisionmaker at Theranos. However, she worked to distance herself from the company’s medical laboratory troubles. She pointed out that others within the company had control over laboratory operations and scientific decision-making.
The WSJ reported that defense lawyer Kevin Downey asked Holmes, “Who was responsible for operational management of the lab?”
Holmes replied, “Sunny Balwani.” She explained that her former No. 2 executive oversaw all the “business parts” of the lab. Meanwhile, the clinical/scientific decision-making, Holmes stated, was the job of the laboratory director and laboratory leadership.
When given the opportunity to cross-examine Holmes, prosecutors focused on Holmes’ response to the 2015 WSJ investigation into Theranos and her retaliatory actions against whistleblower Erika Cheung, a former lab employee who became a source for the WSJ’s expose and a prosecution witness.
According to WSJ live coverage, Holmes testified that Theranos hired a law firm and threatened Cheung with litigation after she left the company, but only did so to protect Theranos’ trade secrets. Holmes acknowledged that Cheung’s concerns about Theranos’ blood-testing technology ultimately were proven correct.
“I think I mishandled the entire process of the Wall Street Journal reporting,” Holmes said.
Closing Arguments
In her closing day of testimony, Holmes was asked if she ever intentionally misrepresented Theranos’ technology to patients and investors, the WSJ reported.
“Never,” Holmes responded.
Asked if investors lost money because of her attempting to mislead them, she answered, “Of course not.”
Clinical laboratory directors and pathologists who have taken a keen interest in the Holmes fraud trial will soon learn if the jury buys her arguments. Closing arguments are set for December 16, after which the jury must decide whether Holmes intended to defraud patients and investors or is guilty only of falling short in her goal of revolutionizing clinical laboratory medicine.
Former CEO also testified that she believed company’s proprietary blood-testing technology could perform ‘any’ clinical laboratory blood test
One relevant question in the federal fraud trial of ex-Theranos CEO Elizabeth Holmes was whether she would testify on her own behalf. That question was answered shortly after the government rested its criminal fraud case against the former Silicon Valley clinical laboratory testing company founder. Holmes took the stand in her own defense, a risk her defense team hopes will pay off in her favor.
During her first three days of testimony leading up to the Thanksgiving holiday break, Holmes—who faces 11 counts of fraud and conspiracy related to her tenure as founder and CEO of Theranos—made headlines by admitting she did personally put the logos of pharmaceutical giants Pfizer and Schering-Plough on reports she sent to Theranos investors and executives at Walgreens and Safeway. She expressed regret for doing so to the jury, but claimed her intent was not to deceive but to give credit to others.
“This work was done in partnership with these companies, and I was trying to convey that,” she testified, according to a trial coverage from Ars Technica.
When asked if she realized that others would assume the pharmaceutical companies—not Theranos—were the authors of the report, Holmes replied, “I’ve heard that testimony in this case, and I wish I’d done it differently.”
If found guilty, Holmes—who once claimed Theranos’ Edison proprietary blood-testing technology would to be able to complete as many as 200 clinical laboratory tests using a single finger-stick of blood—could face maximum penalties of 20 years in prison, a $2.75 million fine, and possible restitution.
The illustration above depicts ex-Theranos CEO Elizabeth Holmes testifying on her own behalf. Former Santa Clara County prosecutor Steven Clark, JD, told The Mercury News, “(T)he best person to say what Elizabeth Holmes’ intent was is Elizabeth Holmes, and that’s why I think she’s taking the stand. … I think the jury will like her.” That remains to be seen. But there’s no doubt that Clinical Laboratory Directors should take a strong interest in the outcome of this trail. (Graphic copyright: Vicki Behringer/Reuters.)
Holmes Testifies She Believed the Edison Device Could Perform “Any” Blood Test
In its trail coverage, NPR described Holmes’ first three days of testimony “as having involved deflecting responsibility, pointing to the expertise of the Theranos board of directors, lab staff, and other company employees whom Holmes has suggested were close to how [Theranos’] blood analyzers worked.”
According to Reuters, Holmes’ defense team is arguing that Holmes’ always-rosy forecasts about her company’s technology and finances were based on her belief the proprietary Edison device worked as advertised, which, in turn, was based on feedback from pharmaceutical companies, her own employees, and the military.
During her testimony, Holmes compared a traditional blood-testing device to Theranos’ “3.0” device, which she said would reduce the human-error rate that can occur during blood sampling.
“If we had the ability to automate much of that process, we could reduce the error associated with traditional lab testing,” she told the court.
Reuters reported that Holmes told jurors her confidence in the Theranos device was in part due to how well the unit had performed in studies completed in 2008 and 2009, including those run by drug companies such as Novartis.
The Mercury News described Holmes as speaking with “confidence—and frequently a small smile”—during her opening day of testimony.
Asked by one of her lawyers, “Did you believe that Theranos had developed technology that was capable of performing any blood test?” Holmes responded, “I did.”
Holmes Testifies about Military’s Alleged Use of Edison Device
Prosecutors maintain that Holmes knew Theranos’ proprietary blood-testing technology had serious accuracy issues yet lied about its capabilities and use to lure investors. One of those false claims included allegedly stating the US military was using the Edison device on the battlefield. Earlier in the trial, CNBC reported, prosecution witness Brian Grossman, Chief Investment Officer at PFM Health Sciences, which invested $96 million into Theranos, testified he was told in a 2013 meeting with Holmes and Balwani that Theranos technology was being used in medical-evacuation helicopters.
However, on the witness stand, Holmes described Theranos’ projects with the US military as much more limited in scope than the descriptions outlined by investors testifying for the prosecution.
According to The Wall Street Journal (WSJ), Holmes told jurors a 2010 partnership between Theranos and a US Army Institute of Surgical Research doctor in Texas looked into using the Theranos device to measure blood markers to detect kidney performance. A second project involved the military’s Africa Command, which was determining whether the device could withstand high temperatures. Holmes testified the devices used in Africa “held up well,” though some modifications were needed, and some issues were revealed with the touchscreen.
Should Holmes Have Testified on Her Own Behalf?
Trial experts maintain Holmes’ decision to testify in her own defense could backfire.
“It’s always a risk to put your client on because if they make a mistake they can sink the whole case,” former Santa Clara County prosecutor Steven Clark, JD, told The Mercury News. He added, “what’s at issue here is Elizabeth Holmes’ intent. And the best person to say what Elizabeth Holmes’ intent was is Elizabeth Holmes, and that’s why I think she’s taking the stand. She’s very charismatic. She’s really good on her feet. And I think the jury will like her.
“This is the pitch meeting of her life,” Clark added. “She’s going to be explaining herself to 12 people as to what was in her mind.”
Judge Drops One Count Due to Prosecution Error, Government Rests Its Case
Holmes is now charged with nine counts of wire fraud and two counts of conspiracy to commit wire fraud after the government dropped one count of fraud from the indictment. According to WSJ coverage of the trial, US District Judge Edward Davila blocked a patient named in the indictment as “B.B.” from testifying because of a filing error by the prosecution. The judge’s decision resulted in the government dropping one count.
The government rested its case against Holmes on November 19 following testimony from independent journalist Roger Parloff, who wrote a flattering 2014 Fortune magazine story on Holmes. He later redacted his earlier writing in another Fortune article, titled, “How Theranos Misled Me.”
The government alleged Holmes used media publicity as part of her scheme to defraud investors, patients, and physicians. All totaled, 29 witnesses appeared for the prosecution, the WSJ reported.
Former Theranos Chief Operating Officer Ramesh “Sunny” Balwani—Holmes’ one-time boyfriend—faces similar charges of defrauding patients, investors, and physicians. His trial is expected to begin in January 2022.
Clinical laboratory managers and pathologists who have watched the federal court proceedings with keen interest should expect the trial to wrap up at the conclusion of Holmes’ testimony, just in time for the Balwani fraud trial to begin.
Pathologist Kingshuk Das, MD, tells jurors he voided 50,000 to 60,000 blood-tests from a two-year period due to unreliable results
As the prosecution in the criminal fraud trial of ex-CEO Elizabeth Holmes closes in on resting its case, a fourth and final former Theranos laboratory director took the stand to describe the problems he encountered when overseeing the startup’s medical laboratory operations.
Los Angeles, Calif., board-certified clinical pathologist Kingshuk Das, MD, testified that he reported directly to Holmes and repeatedly warned her about problems and errors with the company’s Edison blood-testing technology, CNBC reported. While describing the proprietary technology’s reliability issues, Das spoke of one conversation with Holmes in which he pointed out that female patients were receiving test results showing abnormal levels of prostate-specific antigen, or PSA, which typically is associated with the male prostate gland.
“Females should generally not have PSA detectable,” Das said during testimony. He “recalled that Holmes offered an alternate explanation, citing ‘an article or two’ claiming rare breast cancers might cause PSA results in women,” CNBC reported.
Assistant US Attorney Robert Leach, JD then asked Das, “Was that explanation satisfying to you?”
“It seemed implausible,” Das replied.
According to CNBC, Das—who worked at Theranos from March 2016 until June 2018—testified that he “voided every test on the Edison devices from 2014 and 2015” and that he had “explained to Holmes that ‘these instruments were not performing from the very beginning.’
During his testimony, Das explained, “I tried to present it in a more understandable format. I recall [Holmes] offering an alternative explanation,” CNBC reported.
Das testified that “Holmes told him it wasn’t an instrument failure but rather a quality control and quality assurance issue,” CNBC reported.
According to The Wall Street Journal (WSJ), corrected reports were issued to doctors for an estimated 50,000 to 60,000 voided results.
CMS Audit: Theranos Lab Posed ‘Immediate Jeopardy to Patient Health and Safety’
The CMS report stated, “As a result of the survey, it was determined that your facility is not in compliance with all of the conditions required for certification in the CLIA program. … The deficient practices of the laboratory pose immediate jeopardy to patient health and safety,” CNBC reported.
Former Theranos Laboratory Director pathologist Kingshuk Das, MD, testified in the Elizabeth Holmes fraud trial that, when he was hired, he was not told the laboratory had previously been inspected by the Centers for Medicare and Medicaid Services and found deficient. He testified in federal court that he ultimately voided an estimated 50,000 to 60,000 clinical laboratory test results due to the unreliability of the proprietary Edison blood-testing devices. (Photo copyright: LinkedIn.)
Testimony of Four Former Theranos Lab Directors
Das is the fourth Theranos laboratory director to take the stand. He joined the startup in 2016 and was laid off in 2018.
Previous reporting in Dark Daily and our sister publication The Dark Report covered court testimony from the three lab directors who preceded Das (click on names to be taken to those stories):
Lynette Sawyer, DPH, who told jurors she never set foot inside Theranos’ lab while serving as co-director;
Sunil Dhawan, MD, who was former Theranos Chief Operating Officer Ramesh “Sunny” Balwani’s personal dermatologist, and who while Theranos’ lab director worked a total of five to 10 hours and only went to the lab twice; and,
Adam Rosendorff, MD, PhD, a board-certified pathologist, who previously testified he quit Theranos because the technology did not work, CNBC reported.
Rosendorff provided some of the trial’s most explosive news when it was revealed that he was the whistleblower behind The Wall Street Journal’s exposé into Theranos that first raised questions about the startup’s technology and operations.
Defense Claims Holmes Did Not Intentionally Mislead Investors
As noted in The Verge, Holmes’ defense strategy centers on convincing jurors she did not intentionally mislead investors, patients, physicians, and clinical laboratories about Theranos’ proprietary technology, but that she simply failed to achieve the goals she set for Theranos.
“Trying your hardest and coming up short is not a crime,” defense lawyer Lance Wade, JD, told jurors in his opening statement, The Verge reported. “And by the time this trial is over, you will see that the villain the government just presented is actually a living, breathing human being who did her very best each and every day. And she is innocent,” Wade added.
While Holmes is not expected to take the stand in her own defense, prosecutors used her own words against her last month when they played audiotapes for the jury of telephone calls Holmes made to investors in 2013. According to KRON4-TV in San Francisco, Holmes told investors Theranos’ revenues would reach $140 million in revenue in 2014, though the company had not recorded any revenue the two prior years.
Legal analyst Michele Hagan, JD, a former San Francisco Assistant District Attorney, told KRON4-TV the audiotapes are likely to impact the jury.
“It’s very powerful testimony when you can use the defendant’s own words, and these audiotapes can incriminate her,” Hagan said.
Holmes, 37, faces maximum penalties of 20 years in prison and a $2.75 million fine if convicted of two counts of conspiracy to commit wire fraud and 10 counts of fraud, plus possible restitution, the Department of Justice has said. Balwani’s criminal fraud trial is scheduled to begin in January 2022.
With the prosecution just inches away from resting its case, clinical laboratory managers and pathologists will not have to wait long to learn if Holmes’ defense team mounts a defense against fraud charges or allows the case to be turned over to the jury.
Romantic musings between the now-defunct Theranos’ CEO and COO may be introduced to undercut Holmes’ claims of ‘intimate partner abuse’
Medical laboratory professionals did not have to wait long for the first prosecution bombshell to explode during the opening week of the federal criminal fraud trial of former Theranos CEO Elizabeth Holmes.
In court filings leading up to the September 8 trial in San Jose, Calif., Holmes’ defense team revealed plans to claim “intimate partner abuse” by Holmes’ then boyfriend, Theranos Chief Operating Officer Ramesh “Sunny” Balwani. The plan was for Holmes to testify that Balwani threw “sharp” objects at her and controlled how she ate and dressed, impacting her “state of mind” at the time of the alleged crimes.
But prosecutors countered that claim by releasing six pages of text messages between the former couple, which took place between May 2015 and July 2015, as Theranos became the target of whistleblower accusations and a company employee who began secretly speaking to the Wall Street Journal (WSJ). Later that year, the WSJ published an investigative report that brought to light questions about Theranos’ blood-testing technology and the faulty clinical laboratory test results it reported to physicians and patients.
Holmes and Balwani kept their relationship hidden from the public, but their private text messages reveal intimate exchanges that likely will be introduced by prosecutors to undercut Holmes’ claims of abuse.
Within the 164 text messages were these exchanges:
“You are breeze in desert for me” [Holmes]
“My water” [Holmes]
“And ocean” [Holmes]
“Meant to be only together tiger” [Holmes]
“Madly in love with you and your strength” [Holmes later that day]
The following day:
“On route to dinner. Missing you” [Holmes]
“Missing you too” [Balwani]
“You more” [Holmes]
Balwani then turned his attention to the whistleblower within Theranos:
“I’m narrowing this down in CLIA. Down to 5 people. Will nail this mother [explicative omitted]” [Balwani]
“Who do u think” [Holmes]
“Now we have legal grounds” [Holmes]
“Yes” [Balwani]
Later Holmes texted:
“Feel like the luckiest person in the world BC I have you” [Holmes]
“We will come up with good responses to the questions and we will turn this around” [Balwani]
“Love” [Balwani]
“Transcend” [Holmes]
“We will” [Balwani]
The following month:
“Onboard. Love.” [Balwani]
“Taking off baby” [Balwani]
“Missing you” [Holmes]
“Missing you too baby. Just arrived at the office. Will prepare” [Balwani]
“Xxx” [Holmes]
Prosecutors in the federal fraud trial of former Theranos CEO Elizabeth Holmes (above, left) have included in a court filing 180 text messages sent between Holmes and former Theranos COO Ramesh “Sunny” Balwani (above, right) that reveal their romantic involvement and efforts to unearth the whistleblower within the failed blood-testing company. (Photo copyright: Yichuan Cao/NurPhoto via Getty Images [Holmes], Justin Sullivan/Getty Images [Balwani].)
Does Affection Rule Out Abuse?
In San Francisco, KPIX 5 television reported that legal experts predict the texts may not have the impact in the trial that outside observers expect, since, they said, expressions of affection do not rule out the possibility of an abusive relationship, which is expected to be one aspect of Holmes’ defense strategy.
Holmes, 37, who according to court documents faces 10 counts of wire fraud and two counts of conspiracy to commit wire fraud, is alleged to have misled investors, clinical laboratories, patients, and healthcare providers about Theranos’ proprietary blood-testing technology, which Holmes claimed could perform hundreds of medical laboratory tests using only a finger-prick of blood. If convicted, Holmes could face up to 20 years in prison, fines, and payment of restitution. She has pleaded not guilty.
Testimony of Theranos’ Corporate Controller
The prosecution opened the trial with questioning of Theranos’ longtime corporate controller Danise Spivey Yam. According to The Wall Street Journal, Yam testified she provided revenue projections to a company hired to value Theranos stock that ranged from $50 million in 2013 to nearly $132 million in 2016. Those numbers were much more modest than company projections of $140 million in revenue in 2014 and $990 million in 2015, which were given to investors.
“No,” Yam replied, adding that she hadn’t helped prepare it.
Former Theranos employee Erika Cheung, who according to court testimony worked in the company’s laboratory testing blood samples, testified that she left Theranos after six months because of concerns over Theranos’ blood-testing practices and data manipulation when machines failed quality tests.
Cheung ultimately alerted federal regulators to the company’s failure to meet industry standards and expressed her concerns about Theranos’ Edison mini-blood-lab machine.
“You’d have about the same luck flipping a coin as to whether your results were right or wrong,” Cheung testified about the accuracy of the Edison, CNBC reported. “It was concerning to see this degree of failure; this was not typical for a normal lab.”
During cross examination, CNBC noted that one of Holmes’ defense attorneys highlighted the professional qualifications of Theranos lab directors and other scientists at Theranos, including 52 scientists with PhDs and 10 medical doctors. He also noted that the validation reports for assays that Cheung had testified were problematic had been approved for lab use by a lab director and vice president, not Holmes.
With more than 200 witnesses expected to testify, the ongoing Holmes fraud trial is estimated to last three to six months. Pathologists and clinical laboratory scientists who are following the Theranos fraud trial with keen interest can look forward to more Dark Daily coverage. Click here to read our previous coverage of the Holmes/Theranos medical laboratory fraud saga.
