Seeking Validation: the Evolution of Theranos

Photo credit: BBC, 14 August 2014

Elizabeth Holmes, CEO of Theranos, was speaker at a special session of the American Association for Clinical Chemistry’s Annual Scientific Meeting and Clinical Lab Expo in Philadelphia today. Her much anticipated appearance was met with both controversy (AACC was careful to note her appearance was NOT an endorsement) and with intrigue (as the clinical and research communities have long awaited the opportunity for a peek at the science behind the mystery tech).

Ms. Holmes began with a 45-minute presentation unveiling the latest Theranos technology: miniLab, a small 2.5 cubic-foot analyzer, capable of handling a variety of methodologies for lab testing. She identified several of its components (also found in typical laboratory processes and analyzers) noting that everything was miniaturized and consolidated to provide a platform with a small footprint which could be distributed for remote testing using cartridges. These cartridges contain a variety of assays/methods (within the same cartridge) that the miniLab can simultaneously and/or sequentially process to allow such multi-method testing from the same small specimen sample. Additional testing could be added to the platform via additional cartridges as new tests/assays are developed. A video showed how these cartridges contain testing components to allow for the variety of methods used and how, in addition to processing on the miniLab, they can be used in a centralized laboratory to perform testing on specimens collected and transported to the lab.

She also talked about the research Theranos has conducted on their fingerstick collection process (including skin prep with detergent / alcohol, dry times, hand positioning, wiping away the first drop of blood, and avoiding milking the finger for blood), as well as how storage and transportation of the micro-specimens will continue to be researched and evaluated, as that part of the pre-analytical process can be fraught with problems. Photos showed the nanotainer and a new collection cartridge (using EDTA and/or Sodium-Heparin as anti-coagulants) for collection of capillary blood, labeled with 2-D barcodes for patient identification.

Ms. Holmes then provided data on how these miniLab results demonstrate precision and accuracy, and how they (as well as a novel molecular test Theranos has developed for Zika) fare with comparative methods. This showed a few specific tests/examples, representative of the methodologies utilized by the miniLab to perform analysis. Following the presentation, a 45-minute Q&A session with Elizabeth and her team of scientists was moderated by AACC leaders. However, the time provided was still insufficient for the deluge of questions from an audience well-versed in clinical science and technology.

Acknowledging that attendees’ questions were to focus on the science of Theranos (and not the CLIA deficiencies, CMS sanctions, or federal criminal investigation), here is what we learned:

  • The technology has changed/evolved. What was presented today is different; it’s not the Edison technology previously sited and upon which Theranos’ one FDA-approved test (Herpes Simplex Virus) was based. Perhaps that has something to do with the lack of FDA approval (of Edison, test methodologies, and the Nanotainer collection device), CLIA deficiencies (failed inspection at the Newark lab), and CMS sanctions (assumed to yet be appealed). All renditions of the new miniLab technology included disclaimers that the analyzer and the cartridges are NOT FDA approved for sale, nor are the collection devices. Frankly, it appeared a lot has been accomplished in a short amount of time (i.e. starting over, nearly from scratch, on the technologies for testing and collection) and that’s why there isn’t much data yet.
  • The business strategy has changed/evolved. Holmes’ tests cannot be distributed to other labs (to use to perform testing) without FDA approval; meaning until her technologies receive this approval, distribution cannot occur, and testing can only be done as Laboratory-Developed Tests in Theranos’ CLIA laboratories (now jeopardized by the failed inspection and sanctions). Her previous plan to use patient service centers for collection (with transport to a central lab for testing) would have allowed her to proceed with business while she awaited CLIA-waived approval for Edison so she could deploy it to these centers). However, this was thwarted by CMS when they deemed her Nanotainer collection tube a medical device that also required FDA approval. This left her with no choice but to use competitors’ devices for fingersticks (or to collect venous specimens). This, complicated by the inspection woes, led Walgreens to sever ties.
  • Theranos needs validation to succeed. Where better to seek approval (if not an endorsement) than at a scientific conference? By seeking validation of Theranos’ science and technology from respected experts, Holmes can gain credibility, and also the expertise she so desperately needs to guide the research and data collection that can prove her technology works (data presented did not appear to be sufficient for true clinical correlation studies). She appealed to the audience that her technology will allow better access – not as waived tests without quality control, but rather as a system to remotely collect and process tests with results appropriately managed by credentialed lab personnel – since it can be distributed to remote locations but with oversight centralized to a lab where experts in each methodology can provide interpretation. Perhaps this showed the most effort of late – to accomplish connectivity of the distributed miniLabs to a centralized Theranos lab (the one in Arizona, still accredited to perform testing?) – so patient testing can still proceed?

It’s still unclear if Ms. Holmes truly understands the necessity of experienced medical lab scientists (operationally proven), if not just the approval of the scientific community for method validation. But at least she has recruited a few doctors / scientists to round out her board of business and political advisors.

Politicians or pundits, in Philadelphia at the end of the day, there are still many questions left unanswered. And Theranos’ technology is still nowhere near ready for patient testing.

 

For those seeking tangible returns on already validated methods, see There Will Be Blood – Investing in the Clinical Laboratory Space via Laboratory Corp of America and Quest Diagnostics.

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