News

Former lab director acknowledges attempts at quality control during time at Theranos

Also, doctor testifies to evaluation of company's assays

Elizabeth Holmes, the CEO and founder of Theranos, a health care technology company, listens as Deputy Secretary of Defense Ash Carter speaks at Stanford University in Palo Alto on April 17, 2013. Courtesy Glenn Fawcett/DoD via Bay City News.

Cross-examination of former Theranos laboratory director Adam Rosendorff continued on Wednesday in the federal trial against company founder and CEO Elizabeth Holmes.

Defense attorney Lance Wade spent several hours trying to rebut testimony by Rosendorff and other witnesses about problems with the Theranos blood tests, recurrent quality control issues and management pressure to move forward at all costs.

Holmes is charged with making false and misleading statements to investors, doctors and patients about Theranos' blood-testing technology. If convicted, she faces up to 20 years in prison and $3 million in fines.

Expanding on Rosendorff's testimony Tuesday that he never authorized a Theranos test for patients if he believed the test was "inaccurate" or "unreliable," Wade established that Rosendorff would only "run a patient sample if the (testing) instrument passes quality control."

Rosendorff testified that he oversaw quality control issues in the clinical lab and expected the procedures to be followed.

Help sustain the local news you depend on.

Your contribution matters. Become a member today.

Join

As lab director, Rosendorff was also responsible for compliance with federal regulations. He testified that he took those obligations seriously and had "many battles" with Theranos COO Sunny Balwani over regulatory issues.

Wade countered by displaying an email string in which Rosendorff insisted that certain tests needed more documentation before the public launch of Theranos testing sites at Walgreens in November 2013.

Rather than fighting back, Balwani emailed back that he had spoken to various teams and that they "are all going to put long hours and do whatever it takes to get this done."

In a rare moment of levity, after getting Rosendorff to acknowledge how many responsibilities he had as lab director, Wade said "that's why you got paid the big bucks," right?

"Not as big bucks as you get paid," Rosendorff shot back, before agreeing that his salary at Theranos was $240,000 a year.

Stay informed

Get daily headlines sent straight to your inbox in our Express newsletter.

Stay informed

Get daily headlines sent straight to your inbox in our Express newsletter.

Rosendorff added that, considering all the quality control issues he had to deal with at the company and the legal fees he has been charged since, he should have been paid "much, much more."

U.S. District Judge Edward Davila told jurors to ignore that last comment.

Wade also poked holes in Rosendorff's testimony Tuesday that, as per Balwani, no one "was allowed to go in and out of Normandy lab" — where the now-infamous Theranos Edison machines were kept — on days that regulators came to conduct audits.

Putting up an email from Holmes about the "path" the auditors would take through the building in December 2013 and how to "avoid areas that cannot be accessed," along with an employee response that bulletin boards would be covered with paper, Wade tried to spin the exchange as an effort to protect trade secrets.

Rosendorff was having none of it, responding, "Who would pin trade secrets to a bulletin board?"

But Rosendorff then agreed that he was "always transparent" with the inspectors, that he "didn't hide" the Normandy lab on the day of the audit and that he would have shown the lab to inspectors if asked.

He testified that the lab "moved on with a clean bill of health" after the audit found only minor deficiencies.

Rosendorff also testified to some successes in getting the Theranos fingerstick methodology to work on the Edison machines.

Rosendorff said he "continued to validate tests" for use on the Edisons throughout his time at the company, a point that Wade drove home by showing Rosendorff a series of validation reports, ranging from prostate cancer screening to testosterone and Vitamin D levels, that he signed over a 13-month period.

Rosendorff acknowledged that he believed each test "met all the appropriate legal requirements" and "was appropriate to use" in the lab on patients.

Once Theranos began testing actual patients, Rosendorff sometimes stopped the running of specific tests or the reporting of sketchy test results but he "never instructed the Edison team to just stop using the devices altogether."

Wade then walked Rosendorff through a quality control presentation on Theranos testing at Walgreens, noting that out of more than 600 tests given in the first quarter of 2014, only 11 had issues. Data for later quarters likewise showed relatively few problems, even as more tests were administered.

Rosendorff agreed that the document, prepared by Theranos' quality control manager, said what it said but opined that "something was not squaring up," as he remembered dealing with more frequent quality control issues and test failures during that time.

Cross-examination of Rosendorff was suspended until Friday due to a scheduling issue.

Prosecutors then called Dr. Victoria Sung, a former Celgene bioscientist who worked at the biopharmaceutical company during its evaluation of Theranos assays for use in a clinical trial in the 2009-2012 timeframe.

Although Sung and her team had wanted to "endorse" the portable and seemingly patient-friendly technology "wholeheartedly," they couldn't.

When the Theranos assay results were compared to results from Celgene's lab partner — a company that used traditional testing methods and was their "gold standard" for the clinical trial — "the results did not match up."

In April 2012, Sung notified Theranos that Celgene was going to stick with standard blood-testing methods.

A front row seat to local high school sports.

Check out our new newsletter, the Playbook.

Follow Palo Alto Online and the Palo Alto Weekly on Twitter @paloaltoweekly, Facebook and on Instagram @paloaltoonline for breaking news, local events, photos, videos and more.

Get uninterrupted access to important local crime news. Become a member today.

Former lab director acknowledges attempts at quality control during time at Theranos

Also, doctor testifies to evaluation of company's assays

by /

Uploaded: Thu, Sep 30, 2021, 8:54 am

Cross-examination of former Theranos laboratory director Adam Rosendorff continued on Wednesday in the federal trial against company founder and CEO Elizabeth Holmes.

Defense attorney Lance Wade spent several hours trying to rebut testimony by Rosendorff and other witnesses about problems with the Theranos blood tests, recurrent quality control issues and management pressure to move forward at all costs.

Holmes is charged with making false and misleading statements to investors, doctors and patients about Theranos' blood-testing technology. If convicted, she faces up to 20 years in prison and $3 million in fines.

Expanding on Rosendorff's testimony Tuesday that he never authorized a Theranos test for patients if he believed the test was "inaccurate" or "unreliable," Wade established that Rosendorff would only "run a patient sample if the (testing) instrument passes quality control."

Rosendorff testified that he oversaw quality control issues in the clinical lab and expected the procedures to be followed.

As lab director, Rosendorff was also responsible for compliance with federal regulations. He testified that he took those obligations seriously and had "many battles" with Theranos COO Sunny Balwani over regulatory issues.

Wade countered by displaying an email string in which Rosendorff insisted that certain tests needed more documentation before the public launch of Theranos testing sites at Walgreens in November 2013.

Rather than fighting back, Balwani emailed back that he had spoken to various teams and that they "are all going to put long hours and do whatever it takes to get this done."

In a rare moment of levity, after getting Rosendorff to acknowledge how many responsibilities he had as lab director, Wade said "that's why you got paid the big bucks," right?

"Not as big bucks as you get paid," Rosendorff shot back, before agreeing that his salary at Theranos was $240,000 a year.

Rosendorff added that, considering all the quality control issues he had to deal with at the company and the legal fees he has been charged since, he should have been paid "much, much more."

U.S. District Judge Edward Davila told jurors to ignore that last comment.

Wade also poked holes in Rosendorff's testimony Tuesday that, as per Balwani, no one "was allowed to go in and out of Normandy lab" — where the now-infamous Theranos Edison machines were kept — on days that regulators came to conduct audits.

Putting up an email from Holmes about the "path" the auditors would take through the building in December 2013 and how to "avoid areas that cannot be accessed," along with an employee response that bulletin boards would be covered with paper, Wade tried to spin the exchange as an effort to protect trade secrets.

Rosendorff was having none of it, responding, "Who would pin trade secrets to a bulletin board?"

But Rosendorff then agreed that he was "always transparent" with the inspectors, that he "didn't hide" the Normandy lab on the day of the audit and that he would have shown the lab to inspectors if asked.

He testified that the lab "moved on with a clean bill of health" after the audit found only minor deficiencies.

Rosendorff also testified to some successes in getting the Theranos fingerstick methodology to work on the Edison machines.

Rosendorff said he "continued to validate tests" for use on the Edisons throughout his time at the company, a point that Wade drove home by showing Rosendorff a series of validation reports, ranging from prostate cancer screening to testosterone and Vitamin D levels, that he signed over a 13-month period.

Rosendorff acknowledged that he believed each test "met all the appropriate legal requirements" and "was appropriate to use" in the lab on patients.

Once Theranos began testing actual patients, Rosendorff sometimes stopped the running of specific tests or the reporting of sketchy test results but he "never instructed the Edison team to just stop using the devices altogether."

Wade then walked Rosendorff through a quality control presentation on Theranos testing at Walgreens, noting that out of more than 600 tests given in the first quarter of 2014, only 11 had issues. Data for later quarters likewise showed relatively few problems, even as more tests were administered.

Rosendorff agreed that the document, prepared by Theranos' quality control manager, said what it said but opined that "something was not squaring up," as he remembered dealing with more frequent quality control issues and test failures during that time.

Cross-examination of Rosendorff was suspended until Friday due to a scheduling issue.

Prosecutors then called Dr. Victoria Sung, a former Celgene bioscientist who worked at the biopharmaceutical company during its evaluation of Theranos assays for use in a clinical trial in the 2009-2012 timeframe.

Although Sung and her team had wanted to "endorse" the portable and seemingly patient-friendly technology "wholeheartedly," they couldn't.

When the Theranos assay results were compared to results from Celgene's lab partner — a company that used traditional testing methods and was their "gold standard" for the clinical trial — "the results did not match up."

In April 2012, Sung notified Theranos that Celgene was going to stick with standard blood-testing methods.

Comments

There are no comments yet. Please share yours below.

Post a comment

In order to encourage respectful and thoughtful discussion, commenting on stories is available to those who are registered users. If you are already a registered user and the commenting form is not below, you need to log in. If you are not registered, you can do so here.

Please make sure your comments are truthful, on-topic and do not disrespect another poster. Don't be snarky or belittling. All postings are subject to our TERMS OF USE, and may be deleted if deemed inappropriate by our staff.

See our announcement about requiring registration for commenting.