This article originally appeared on CLN Daily, the official publication of the 68th AACC Annual Scientific Meeting & Clinical Lab Expo. You can see the original article here.
In a widely anticipated special session on Monday evening, Theranos CEO Elizabeth Holmes presented for the first time an inside look at her company’s technology and data. Holmes presented preliminary validation data for a compact instrument called “miniLab,” the inside of a cartridge-based testing system, video and description of micro-collection devices, and a concept called a virtual analyzer.
The miniLab houses numerous modules and detection systems including liquid handling, a camera, a centrifuge, a UV-Vis spectrophotometer, a luminometer and fluorometer, cytometry, sonication, and a thermocycler. With this array of detection systems, the analyzer is designed to analyze serum, plasma, and capillary whole blood samples using single-use cartridges. In addition, Holmes presented method comparison and precision data for a wide-range of analytes including potassium, lipids, HSV-2, lymphocytes (by flow cytometry), and Zika virus.
Holmes described what she called the “Theranos Virtual Analyzer (TVA),” a mechanism for remote viewing, interpretation, and analysis of images and results by experts and expert systems. She used the analogy of point-of-care testing, where preanalytical issues and understanding the technical limitations of the device sometimes require additional expertise in assessing the result. The system also is similar to telepathology, where a remote expert provides objective assessment and interpretation.
In an interview with Holmes on Tuesday, she said that clinical decision support systems could be integrated into these devices and take advantage of substantial datasets generated by distributed miniLab instruments.
During her presentation, Holmes showed a sample collection device and proprietary Nanotainer tubes. Using a video demonstration, Holmes also showed a capillary sample collection device, which relies on a needle puncture and sliding plungers. The draw yields two Nanotainer tubes, each with different additives (EDTA and/or Li-Hep). The tubes have 2D barcodes and are designed for transport, storage, and analysis. As proof of concept, Holmes showed sample matrix comparison data between venous and capillary whole blood for a routine lipid panel (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides), lymphocyte subsets (Total T cells CD4+ T cells CD8+ T cells B cells NK cells lymphocytes), and Zika virus.
The presentation was followed by a Q&A session during which attendees submitted nearly 600 questions via text or a website. The Q&A session was moderated by Dennis Lo, PhD, Steven Master, MD, PhD, and AACC President Patricia Jones, PhD, with help from three additional distinguished AACC members — without any Theranos affiliation — who handled the bolus of audience questions. Jones asked Holmes about the virtual analyzer concept and whether the miniLab delivered the actual results. Holmes responded that her vision is to “decentralize and automate the processing steps,” while maintaining the ability of certified laboratory personnel to oversee the quality of testing.
Master told Holmes that her data “fell far short” of what he expected based on the wide menu that Theranos promised previously. Holmes responded that there had been a lot of news about the company and that Theranos chose this meeting to engage in a scientific discussion with the AACC community.
During an interview on Tuesday, Holmes emphasized that she wishes she had engaged with the laboratory medicine community earlier. “We really want to engage with this community. The best way was to take our core invention and literally open it up and show it at this AACC meeting,” Holmes said. “That is not, of course, indicative of assay validation.”
Asked about existing regulatory issues, Holmes said she is committed to doing better. “We take complete responsibility for our lab operations and are working hard to realize the standards of excellence that we hold ourselves to, and we have talked about it when there were issues,” she said. Holmes described her experience shutting down one of the Theranos clinical labs and the steps she is taking to strengthen the company, such as creating a new scientific advisory board. “We brought in new lab directors, and we rebuilt the quality systems from scratch,” she said.
Holmes emphasized that she remains committed to her vision for the company. “I’ve made the decision to double down and stick by it no matter how hard the path,” she said. “We wanted to come here and literally show you the inside of the box and open ourselves up completely.” She said Theranos will continue to go through the regulatory path to bring new assays and technology to market.
Overall, the session was a unique event with a window into developing technology generating some controversy and perhaps challenging some existing testing paradigms. Asked about whether there will be Theranos abstracts at next year’s AACC Annual Scientific Meeting, Holmes said, “We really want to be involved with AACC and this community…we want to perform studies and realize this potential together. We can’t do it by ourselves.”
The technologies discussed here are not clear or approved by the FDA and are not commercially available.