Yesterday’s presentation by Holmes was made to an audience that was clearly skeptical, and she was careful to avoid discussions about her company’s many issues and federal investigations

DATELINE: PHILADELPHIA, PA.—Yesterday, Elizabeth Holmes, CEO of Theranos, Inc., took the stage at the 68th AACC Annual Scientific Meeting & Clinical Lab Expo (AACC), the nation’s biggest clinical laboratory meeting, purportedly, for the first time ever, to deliver scientific data about her lab company’s diagnostic technologies. She also was there to answer questions from an expert panel before an attentive audience of clinical chemists and pathologists. A large number of journalists also were in attendance.

It may have escaped the notice of most of the audience—but not your intrepid editor—that the last song played over the PA system in the grand ballroom before Elizabeth Holmes was introduced and took the stage was “Sympathy for the Devil,” a big hit for The Rolling Stones in 1968. That song was an appropriate choice, since AACC’s invitation for Theranos to speak means the association is doing its own dance with the devil that some clinical chemists consider to be Theranos.

AACC Not Endorsing Theranos, Simply Providing a Forum for Discussion

Theranos is known to embellish any links it might have with credible parties. To ensure no misunderstanding on the point about an AACC endorsement, when AACC President Patricia Jones, PhD, introduced Holmes, she took extra effort to declare that, in providing a forum for Theranos to present scientific data, AACC was not endorsing the company. Jones added the additional disclaimer that in no way was the association validating the data and technologies that were to be discussed by Holmes.

However, when Holmes stepped up to the podium and began to speak, she delivered a curve ball to the audience. She did not present scientific data about the much-ballyhooed proprietary technology that her company has bragged about in recent years. Instead, Holmes introduced a new lab test product, along with data produced from recent correlation studies involving that lab testing device.

Presentation on the Miniaturization of Clinical Laboratory Testing

She titled her presentation, “Theranos Science & Technology: The Miniaturization of Laboratory Testing.”

While describing this new clinical laboratory testing device, Holmes did not discuss the following elements of its business plan from the past three years:

1) A diagnostic technology that could do the full range of routine and reference testing using a capillary blood specimen collected from a single finger stick (numbering about 200 different assays).

2) Lab test results returned in just four hours after collection.

3) All of this testing done at a price that is just 50% of Medicare Part B clinical laboratory test prices.

Instead, the AACC audience got to hear Holmes “test drive” the new Theranos corporate message and marketing campaign. It is very different from all that has come before.

New Corporate Strategy and New Clinical Laboratory Instrument

Holmes introduced this different corporate business strategy by describing three elements. First was a discussion of how Theranos sees the opportunity to use miniaturization of lab testing as a way to develop an entirely different way to collect micro specimens and perform testing with small quantities of samples locally, while managing the process of analysis and reporting from a central location.

The foundation for this new corporate approach to diagnostic testing, as described by Holmes, is a near-patient testing device that Theranos refers to as a “miniLab” that works together with the “Theranos Virtual Laboratory” (TVL). The TVL is a cloud-based laboratory informatics system that will analyze the data performed by each remote miniLab, perform necessary QA/QC functions, validate results, and then report results.

Elizabeth Holmes presentation, “Theranos Science & Technology: The Miniaturization of Laboratory Testing,” given at the 68th AACC Annual Scientific Meeting & Clinical Lab Expo in Philadelphia. (Video copyright: AACC/YouTube.)

In the second section of her presentation, Holmes revealed the design and functions of the miniLab. She showed how the instrument is designed to use different types of cartridges that would perform a wide range of diagnostic assays, ranging from chemistry and immunoassay to hematology and molecular diagnostics. These bench-sized miniLab devices include multiple analytical instruments, including:

• a spectrophotometer;

• a luminometer;

• a fluorometer;

• a cytometer; and

• a fluorescence-based isothermal detector.

All of this provided context for the third section of her presentation. Holmes then showed the precision and comparison data that Theranos generated by running about 11 different types of assays on its miniLab instrument.

Q&A Session Featured Panel of Medical Laboratory Experts

Upon conclusion of her presentation, it was time for the scheduled question and answer session. On stage were three experts from the AACC:

Patricia M. Jones, PhD, President of AACC, Children’s Medical Center of Dallas;

Stephen Master, MD, PhD, Weill Cornell Medical College; and

Dennis Lo, MD, Chinese University of Hong Kong

Representing Theranos were:

• Elizabeth Holmes, Founder and CEO;

Chinmay Pangarkar, PhD, Vice President;

Daniel L. Young, PhD, Vice President, and

Samartha Anekal, PhD, Vice President

The audience was packed in a ballroom seating 2,400 people, with some additional rooms offering a video feed of the session. The expert panel asked probing questions of Holmes and her research and development team. In upcoming Dark Daily e-briefings, some of these exchanges will be presented.

Elizabeth Holmes, CEO, Theranos (center right), on stage at the 2016 annual AACC meeting, along with Stephen Master, MD, PhD, Weill Cornell Medical College (far left); Patricia M. Jones, PhD, President of AACC, Children’s Medical Center of Dallas (center left); and Daniel L. Young, PhD, Vice President, Theranos (far right). (Photo copyright: AACC/YouTube.)

Elizabeth Holmes, CEO, Theranos (center right), on stage at the 2016 annual AACC meeting, along with Stephen Master, MD, PhD, Weill Cornell Medical College (far left); Patricia M. Jones, PhD, President of AACC, Children’s Medical Center of Dallas (center left); and Daniel L. Young, PhD, Vice President, Theranos (far right). (Photo copyright: AACC/YouTube.)

What was the overall reaction of the audience? Individuals commenting to your Dark Daily editor expressed skepticism that the new product shown today by Holmes fell short of being “breakthrough” or “disruptive to clinical laboratory testing” as it is performed today.

Expert panelist Stephen Master, MD, PhD, was one of those skeptics. Bloomberg’s story about Holmes’ presentation stated, “‘It is certainly not yet a game changer,’ Master said. While the instruments they presented appeared to have some good engineering behind them, ‘I certainly didn’t see anything that lives up to the expansive claims they made.’”

For her part, Holmes made a short statement about her objectives in presenting to the AACC membership. She said, “The purpose of the presentation today was to introduce our invention and the architecture and the design of the system that’s capable of running these broad range of test methodologies on a single platform.”

A final note on today’s presentation. Elizabeth Holmes did not show up wearing her trademark black turtleneck blouse. Might that be a quiet signal that Theranos wants its future to be much different than its past?

Your Dark Daily Editor,

Robert L. Michel
Related Information:

Under Siege, Theranos Introduces a New Technology

Theranos Unveils “Minilab” Invention to a Skeptical Audience

Theranos Ignores Scandal and Shows Off New Blood Testing Machine

Theranos Makes Case to Laboratory Experts

Live Blog: Theranos’ Elizabeth Holmes Presents New Blood-Testing Machine

Theranos’ Highly-Anticipated Defense of Its Tech Is Called a ‘Bait-and-Switch’

Expecting Data from Theranos, Lab Experts Get New Product

Video: Theranos Reveals Diagnostic-Testing Tech at Meeting

Elizabeth Holmes Is Finally Presenting Theranos Data as Company Collapses

Theranos Still Trying

Video: Behind The Scenes at Theranos

Theranos Intros New ‘Fingerprick’ Testing Tech Despite Its Woes

Theranos, Embattled Laboratory, Shifts to Medical Machines

Theranos’ Hail Mary Pass: A Tabletop Laboratory

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

A Key Test for Theranos CEO: Convincing the Experts

Embattled Theranos Chief Plans to Reveal Science Behind ‘Groundbreaking’ Technology, Amid Skepticism

The Dark Report Theranos Coverage

Dark Daily quoted in Washington Post: Theranos’ ‘groundbreaking’ approach isn’t breaking much new ground