Theranos' Elizabeth Holmes speaks out: 10 things to know

After avoiding The Wall Street Journal for five and a half months in its investigation of her blood test startup Theranos, founder and CEO Elizabeth Holmes finally gave the news platform an interview Wednesday at its WSJD Live global technology conference.

"I have a lot of concerns about this information being misrepresented because I care deeply about what the community that we work with understands and any of their questions," she said in the interview. "And I feel a tremendous obligation to answer those questions and give them clear answers and to make sure they have access to any information that they want to know," she added.

During the half-hour interview, Ms. Holmes addressed the barrage of claims her Palo Alto, Calif.-based company has faced over the past week.

"I read what was written in the article. We disagree with it," Ms. Holmes said in the interview. "We think it was false, and we think it was misleading." The Wall Street Journal stands by the accuracy of its reporting, stating it was "thoroughly reported, fair and wholly accurate."

Here are 10 things to know about the interview with Ms. Holmes.

1. Ms. Holmes confirmed Theranos currently uses the finger prick for just one test. The other more than 240 tests it offers are conducted with larger blood samples draw from patient's arms, according to the report

2. She also confirmed the Food and Drug Administration performed an unannounced inspection in August. She said it was a normal quality system regulation audit, and does not know why it was unannounced.

3. The decision to scale back testing using its "nanotainers" of blood to just one test has nothing to do with the accuracy of the technology or the capability of the devices, she said. Ms. Holmes said this was part of the process of voluntarily transitioning its tiny tubes into the FDA framework from CMS' Clinical Laboratory Improvement Amendments. "We have to move, as a company, from the lab framework and quality systems to the FDA framework and quality systems," Ms. Holmes said in the interview. Theranos has a lot of other technologies that "have nothing to do with the decision to transition the tube," Ms. Holmes said.

4. Edison is no longer in use. Ms. Holmes said in the interview Theranos develops and manufactures many proprietary devices and Edison was one of them. She said Edison was a code name for one of the earliest versions of its technology. "We don't actually use the technology that's being referred to as Edison for anything and haven't for a few years now," she added, correcting the common usage of Edison.

5. Theranos does not submit results from its finger-prick tests for proficiency testing. The proficiency tests determine the accuracy of the lab by comparing it to the average result in the lab's peer group. Ms. Holmes said the company uses a procedure endorsed by CMS, and since its proprietary technologies have no peer technology, it cannot send those results in to be tested.

6. Ms. Holmes refuted the claim made in the first WSJ article that it allegedly diluted blood samples from finger-prick tests to run them on traditional lab machines. Former employees told WSJ Theranos did this to make the volume of the samples fit in the other instruments, according to the report. Ms. Holmes said dilution is a common step in almost every assay. "[Dilution] is an embedded step in a protocol for an assay, but what the Journal described, that we take a sample, dilute it and put it on a commercial analyzer is inaccurate and that's not what we do," she said.

7. Ms. Holmes confirmed the company has changed the wording on its website. The shift to the FDA process has affected Theranos' overall offering she said, so the company regularly updates the language on its site to reflect that. Later in the interview she said, "Just because some guy reports false stuff about us doesn't mean that it changes our business."

8. Ms. Holmes also discredited a statement made by Bill Maris, founder of Google Ventures. Mr. Maris told Business Insider he decided not to invest in Theranos two years ago because it doubted the technology after someone from its team tried out the test at Walgreens. Ms. Holmes said Mr. Maris has never reach out or communicated with Theranos.

9. She also denied previous knowledge of a letter from former Apple executive Jean-Louis Gassée describing discrepancies in his personal test from Theranos. Mr. Gassée said he emailed info@theranos.com in July at still has not received an answer, according to the report.

10. Ms. Holmes also refuted the verity of the sources used by WSJ in its initial report. She said Theranos has reached out to the sources and four of the seven said they never said what the journalist reported. Those sources gave Theranos their word in writing because they wanted to help, Ms. Holmes said. She also said the company will be making several documents public regarding the manner soon.

She also answered the biggest, most important question everyone is asking about Theranos: Does it work?

"I know it does," Ms. Holmes replied.

 

More articles on leadership and management:

Ministry Health Care to cut 500 FTEs: 7 things to know
Which presidential candidate do the most CEOs donate to?
50 top business schools: As ranked by Bloomberg

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Learning Opportunities

Featured Whitepapers

Featured Webinars