What Elizabeth Holmes did and didn't disclose about Theranos at AACC

Elizabeth Holmes, founder and CEO of Theranos, took the stage Monday evening at the American Association for Clinical Chemistry in Philadelphia to present new technologies and prove there is more to the Palo Alto, Calif.-based startup than a series of clinical laboratory issues.

"We're pleased to share our technologies with the entire laboratory industry. It's the beginning of the next phase of the company, as we introduce our technologies to the world," Ms. Holmes stated in an emailed press release. "We also will be working with academic institutions and other independent parties to validate and publish our results."

With many in the audience poised to grill Ms. Holmes about her company's clinical challenges, she chose to use the AACC as a forum to focus on what she called Theranos' "technology business," which she emphasized is independent from its clinical lab. This distinction was essential to Ms. Holmes' presentation, as the integrity of Theranos' clinical labs was slammed by CMS when it revoked its license in April and barred Ms. Holmes from operating other labs for two years.  

Here are four things Ms. Holmes shared at AAC and four questions that remain unanswered.

What Ms. Holmes disclosed:

1. Ms. Holmes' presentation, "The Miniaturization of Laboratory Testing," offered the first-ever glimpse at the architecture of Theranos' new miniLab platform. This 2.5-cubic-foot device has the capability to run a broad range of tests on a single platform, according to Ms. Holmes. Disposable cartridges are put into the miniLab to facilitate the various tests. She also presented the Theranos Virtual Analyzer, which allows for two-way communication with the miniLab device and pave the way for pathologists and lab scientists to analyze tests remotely.

2. As part of this new technology, Theranos has submitted a Zika test to the FDA for emergency authorization. In a press releas,e Theranos said it is not aware of a capillary test for Zika. During the Q&A portion of the Theranos presentation, officials said the company is also considering using a urine test for Zika because it the virus is detectable in urine samples for longer periods of time.

3. Ms. Holmes also shared information and a video depicting the company's capillary collection methods. This included how the sample site is prepared, what the finger stick looks like and how the nanotainers are collected and shipped.

4. Her presence at AACC also demonstrated a new willingness by Ms. Holmes and Theranos to be more transparent and engage with the scientific community. "We came here for a reason," Ms. Holmes said in an interview with Reuters. "I could've gone to an entrepreneur's conference to introduce this technology, but this is the community that we want to engage with, and there's been a lot of confusion about our work." Gaining acceptance, publishing in peer-reviewed journals and conducting third-party studies will not happen in one day and one presentation, she said during the panel Q&A.

What she didn't disclose:

1. Ms. Holmes strayed from answering anything specific about the clinical challenges the company is dealing with. "We know there are a lot of questions about the past, and in the appropriate forum, we'll address them," she said during her presentation. "But today, we're hoping to be able to engage on a scientific exchange on this platform." She was unable to provide a time frame for reopening the California lab shut down by CMS, but said Theranos is building it from scratch.

2. She was reluctant to answer how many analytes can be measured using the miniLab. This is likely due to the backlash Theranos faced last fall for potentially overstating the capabilities of its Edison testing device. Ms. Holmes she said the miniLab is the latest version of the company's technology, and while a few hundred tests have been applied to various Theranos technologies, just one test for herpes is currently cleared by the FDA.

3. Information on the number of tests that can be conducted on the miniLab with a single sample of blood was not included in the presentation. "A person familiar with the matter" told The Wall Street Journal that the data in the presentation showed 11 different blood tests on the miniLab, but the architecture could only complete three to four tests with a microsample of blood, meaning multiple finger pricks would be necessary to complete all 11 tests.

4. Ms. Holmes did not disclose financial information about the company. When pressed about revenue streams following the fallout of Theranos' Walgreens partnership in an interview with Reuters, Ms. Holmes said Theranos has its own standalone wellness centers in Phoenix. Because Theranos is a private company, she declined to offer information on how much the company is worth.

 

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