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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Clinical chemists at AACC pointed out that Holmes did not present data as promised. Instead, she did a speech that advertised her company’s latest medical lab analyzer

DATELINE: PHILADELPHIA—By now, the clinical laboratory industry and the world knows that Theranos Founder Elizabeth Holmes took the stage here last Monday at the annual meeting of the American Association of Clinical Chemistry (AACC). The content of her presentation was given wide play by the national press and, in general, Holmes appears to have failed to impress both the medical laboratory scientists in attendance and the journalists representing some of the world’s most prominent news outlets.

Among those in attendance was your Dark Daily editor, and I reported on the key elements of the presentation given by Holmes last week. However, the details contained within Holmes’ speech are only part of this important story. What is of equal or greater interest to medical laboratory professionals and pathologists is how their peers reacted to the invitation to have Holmes speak at the AACC meeting last week (a joint conference with the American Society for Clinical Laboratory Science—ASCLS), along with their reaction to what Holmes decided to present, their assessment of the diagnostic instrument she unveiled, and how they viewed the data she presented about certain assays performed by the Theranos “miniLab” device.

After Hearing Holmes, Most Clinical Laboratory Scientists Skeptical

From the moment Holmes concluded her presentation and stepped off the podium on Monday afternoon, she, her company, and her comments became the number one subject discussed by attendees in the halls between sessions and in the AACC exhibit hall. And, according to the AACC, about 20,000 people attended the exhibition. This meant that there were many clinical lab industry professionals on hand to express their opinions.

One important point of discussion was whether the AACC leadership made the right decision when it extended the invitation for Holmes to speak at a sanctioned session. (For the record, the presentation delivered by Holmes did not earn CEUs for those in attendance.)

Many Clinical Chemists Unhappy That AACC Allowed Holmes to Speak

Based on the many conversations that happened during the week, it was clear that a significant number of AACC attendees believed that it was inappropriate to give Holmes a forum to speak about her company’s products. Whether those clinical chemists objecting are equal in number to the AACC attendees who thought that it was helpful to science for her to present cannot be determined without a formal survey.

Elizabeth Holmes at AACC

Pictured above is Elizabeth Holmes, Founder and CEO of Theranos, on stage for the question and answer session that followed her presentation at the American Association of Chemistry (AACC) annual meeting in Philadelphia on August 1. Holmes is at far left and, from her left to right, are the three Theranos scientists she brought to help her respond to questions from the clinical laboratory scientists in the audience. They are: Daniel L. Young, PhD, Vice President; Samartha Anekal, PhD, Vice President; and Chinmay Pangarkar, PhD, Vice President. (Photo copyright: AACC.)

Another point of contention that was frequently raised during these conversations was the opinion that Holmes had been given an unwarranted platform to tout her company’s commercial products. Not only did these clinical chemists believe this was not purely a scientific topic, but they pointed out that this same opportunity to discuss commercial products was not available to other companies selling lab testing instruments and kits to medical laboratories.

Most Frequently Asked Question: ‘What Did You Think of the Theranos Presentation?’

However, those two perspectives were outweighed by a topic of greatest interest. The single question that regularly came up within minutes in many, many conversations was “What did you think of the Theranos presentation?” This was particularly true on the exhibition floor, where both lab vendors and the clinical laboratory scientists were equally curious to learn more about the reactions their colleagues had to Holmes and the information she presented during her speech.

It would be safe to summarize most reactions as skeptical. Holmes did not fool many in the audience. “I came to see scientific data about this remarkable technology that could do up to 70 medical laboratory tests on a single drop of capillary blood,” stated one clinical chemist. “Instead, I heard her talk about the new corporate strategy at Theranos, including the details as to how their analyzer works. The data that followed had nothing to do with anything but their new analyzer.”

Theranos Showed Benchtop Analyzer for Medical Laboratory Testing

Another internationally-known clinical chemist was quick to point out that, “Holmes showed us a benchtop lab analyzer that represented some good engineering. But her description of this analyzer indicated that it is performing assays using conventional methodologies. The probe in this instrument samples about the same small quantity of specimen as do the analyzers in my lab,” she observed. “Next, it seemed that the 10 or 12 tests for which Holmes showed data were based on venous blood samples. What happened to doing a dozen or more tests on a single capillary blood specimen collected by a finger stick? What Theranos showed us on Monday seems to be not much different than what we do daily in my lab. Where’s the disruption in that?”

Comments like these are representative of the various conversations Dark Daily had each day on the floor of the AACC exhibition hall. Incoming e-mails from clients and readers consistently echoed these same opinions.

Journalists Expressed Similar Opinions as Medical Laboratory Professionals

The conversations, opinions, and criticisms reported above provide insights about what clinical chemists, pathologists, and lab industry vendors at the AACC annual meeting thought about Elizabeth Holmes and her presentation. It is equally worthwhile to consider what the journalists who listened to Holmes thought about her presentation.

In his story about Holmes’ speech at AACC, reporter John Carreyrou of The Wall Street Journal quoted a clinical chemist: “Every piece of technology [Theranos] presented has been known for many years, and exists in other platforms largely in the same configuration, or in some cases in much more compact form in competitor’s platforms,” said Geoffrey Baird, MD, PhD, an Associate Professor in the Department of Laboratory Medicine at the University of Washington, as well as Medical Director of Northwest Hospital’s Clinical Laboratory, the Director of Clinical Chemistry at Harborview Medical Center, the Laboratory Director of Airlift Northwest.

CBS News: ‘Scientific Community Still Questions Technology Theranos Touts’

Ian Bush, a reporter for the CBS affiliate in Philadelphia, pointed out that many in the audience found the presentation failed to address key concerns about Theranos. He said, “Most of the data in her presentation, though, came not from capillary blood, but instead was drawn by needle from a vein, leaving many in the scientific community—if not regulators and investors—still questioning the technology Theranos has touted.”

Given the reportage by journalists, and the reactions of medical laboratory professionals to the information presented by Holmes during her speech at AACC, one conclusion seems obvious: after years of fawning press coverage and acceptance of statements made by Theranos and Holmes, going forward, both she and her company will be held to a higher standard.

Theranos Has Eroded Its Credibility with Media, Lab Scientists

Stated another way, the executive team and the investors at Theranos have burned through their credibility with the media, the medical laboratory profession, and the public. In the future, the company’s claims will only be accepted if presented with scientific data developed according to accepted standards and reviewed by credible third parties. Much of this data also needs to be published in that peer-reviewed medical journals held in highest esteem.

The AACC has posted the full video of Holmes’ presentation at this URL: (Or copy and paste into your browser: ) Access this video to see both the speech made by Holmes, and the question and answer session that followed.

Your Dark Daily Editor,

Robert L. Michel
Related Information:

Theranos, Inc. Unveils Diagnostic-Testing Technologies at American Association for Clinical Chemistry Meeting

Theranos Founder Elizabeth Holmes Had the Chance for Redemption – and She Blew It

Theranos Just Presented in Front of Thousands of Scientists, but Some Big Questions Remain

What Elizabeth Holmes Did and Didn’t Disclose About Theranos at AACC

Expecting Data from Theranos, Lab Experts Get New Product

Theranos Plunges Ahead into a Murky Future

Theranos CEO Unveils ‘MiniLab’ at Philadelphia Conference

Theranos Unveils “MiniLab” Invention to a Skeptical Audience

Theranos Founder’s Conference Invitation Sparks Row Among Scientists

Disgraced Theranos CEO Elizabeth Holmes Resigns as Obama Advisor

Unpacking The Innards of Theranos’ New Zika-Detection Box

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