Theranos phenomenon – Part 5: Theranos’ presentation at the American Association for Clinical Chemistry Annual Conference 2016

Eleftherios P. Diamandis; Mario Plebani

doi:10.1515/cclm-2016-0737

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Theranos phenomenon – Part 5: Theranos’ presentation at the American Association for Clinical Chemistry Annual Conference 2016

Eleftherios P. Diamandis and Mario Plebani

Published/Copyright: August 30, 2016

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 54 Issue 10

Keywords: diagnostics; new technologies

To the Editor,

The widely anticipated presentation of Theranos at the Annual Conference of the American Association for Clinical Chemistry (AACC) was finally given on Monday, August 1st, 2016 at the Philadelphia Convention Center. This journal has followed the Theranos story closely over the last 2 years and provided frequent updates [1], [2], [3], [4]. Elizabeth Holmes, the Chief Executive of Theranos, presented to an audience of over 2500 clinical chemists and other laboratory scientists, as well as to an impressive number of reporters from national and international media. We have not seen anything like this event, at the previous 30 AACC conferences that we have attended.

First, we would like to comment on the moderation of this difficult event by AACC officials. Although we disagreed with the invitation [4], we acknowledge here that AACC President, Dr. Patricia Jones, made it very clear in her opening remarks that the presentation does not mean that AACC endorses Theranos, and that no CME credits were allocated. She also recruited an excellent panel, consisting of herself, Dr. Dennis Lo and Dr. Steven Master, two highly recognized and respected clinical chemists, who did a good job in asking pertinent questions to Ms. Holmes and her associates. In this respect, AACC lived up to the expectations of high standards and impartiality for this presentation.

Holmes presented to a large and curious, if not hostile, audience. She avoided talking about Theranos’ past and the difficulties of her company [1], [2], [3], [4], [5], [6], [7]. She also made it clear that her presentation would focus on the future, not the past, and she distanced herself from the previous “Edison” instrument and introduced a new analyzer named “MiniLab”. In the first part of her presentation, Ms. Holmes described the engineering behind the MiniLab and explained that it is a compact desktop device that houses a mini spectrophotometer, a mini-luminometer, and mini-flow-cytometer and a mini-PCR machine, along with a centrifuge. We acknowledge the difficulties of putting together all these technologies in a very compact machine, but apart from the engineering challenge, no technological breakthroughs were described. We wonder if this machine can be manufactured efficiently and if it can function reliably long-term, due to its numerous components and moving parts. Time will show if this machine can perform as a robust analytical platform using micro-volumes, and if the sensitivity achieved will be adequate for demanding analytes, such as high sensitivity troponin.

The cartridge included with this system, carrying dry reagents for multiple analytes, was not described in detail. It was not clear what happens to the unused reagents if cartridges with multiple analytes are used for only one or two analytes. We assume that the rest of the reagents will be discarded, increasing the cost per reportable test. Validation of some analytes by Theranos (K⁺, cholesterol, triglycerides, LDL-C, HDL-C, HSV-2 IgG, lymphocyte subsets, ZIKA virus PCR) has shown good results but we do not have independent validation or long-term performance. Data on the majority of important laboratory analytes were not described.

With this new machine, Ms. Holmes seems to have taken a step away from the direct-to-consumer laboratory sector (e.g. testing in pharmacies) and she is now suggesting that their business model includes placement of these machines in hospitals and in point-of-care or doctor’s office environments.

Ms. Holmes also spent significant time describing Theranos’ efforts to optimize fingerpricks for high quality capillary blood retrieval in relatively large amounts. She has shown that her device is suitable for performing tests on site, or for shipping to remote laboratories for further analysis.

Overall, what Ms. Holmes said was relatively straightforward. We did not identify any disruptive technologies or revolutionary new ways of doing what we have been doing in clinical laboratories for years but maybe, we did not hear the whole story. While we appreciate that her approach will save some valuable real estate, due to the compact size of her machine, we suspect that this benefit may compromise quality, critical assay performance characteristics such as sensitivity or the long-term reliability of the instrument.

We believe that Theranos will face some challenges in the future, as summarized below:

Ms. Holmes admitted that her new machine is not ready and that they are still configuring optimal panels for their cartridges. We do not know how much time it will take to do this, but being familiar with in-vitro diagnostics over many years, we suspect that it may take more time than originally thought. The system has to still be independently validated and the results published (in progress). They also need to receive Food and Drug Administration (FDA) approvals for their new system and assay tests, as well as their blood collection device.
Based on the previous history of Theranos, we anticipate that they will face increased scrutiny and it may be difficult to convince skeptics that their new technologies are better than the old ones.
It remains to be seen if their system can match the performance characteristics of larger, conventional analyzers.
There are already many alternative machines for their targeted niche. For example, we have seen at the AACC exhibition many other companies marketing simpler products. The Zika virus assay was one of the most talked about assays at the Theranos presentation, but Dr. Dennis Lo suggested that it may not be as sensitive as current technologies for detecting the virus. This remains to be seen in evaluation trials.

Regarding fingerprick capillary blood testing: We have seen at the AACC exhibition smaller and less traumatic needles that permit almost painless collection of venous blood for laboratory analysis. One of us (EPD) has already tested one of these new blood collection devices and found out that it was totally painless and collection time was less than a minute. These related technologies will likely be preferable to patients than fingerpricks, which, as we mentioned earlier, are more painful [1].

The video of Miss Holmes’ presentation can be found at this link: https://www.youtube.com/watch?v=n6JRG733ReQ.

The future of Theranos will depend on the quality and the reliability of their products. We are looking forward to see Theranos validating and publishing on their products in the near future and having them return to the AACC Conference as exhibitors and sponsors.

Corresponding author: Eleftherios P. Diamandis, MD, PhD, FRCP(C), FRSC, Head of Clinical Biochemistry, Mount Sinai Hospital and University Health Network, 60 Murray St. Box 32, Floor 6, Rm L6-201, Toronto, ON M5T 3L9, Canada, Phone: +(416) 586-8443

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

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Accepted: 2016-8-18

Published Online: 2016-8-30

Published in Print: 2016-10-1

Articles in the same Issue

https://doi.org/10.1515/cclm-2016-0737

Keywords for this article

diagnostics; new technologies