CEO Elizabeth Holmes, in a special presentation, "The Miniaturization of Laboratory Testing," at the 68th American Association for Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo, also provided precision and method comparison studies for various assays run on the company's miniLab platform.
Holmes outlined Theranos' approach to miniaturizing analytical testing equipment across different testing methods, including hematology, immunology, clinical chemistry, immunochemistry, and nucleic acid amplification, and integrating those methods into a single platform, known as the Theranos Sample Processing Unit, or "miniLab."
"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. We also will be working with academic institutions and other independent parties to validate and publish our results," Holmes said.
The company's testing system is comprised of the miniLab sample-processing unit along with software, called the Theranos Virtual Analyzer (TVA), which will enable remote operation of the unit through a bi-directional connection.
Together, this integrated platform is designed to process small capillary whole blood and plasma samples using the company's capillary blood collection devices, the Sample Collection Device (SCD) and Nanotainer™ tubes.
Theranos also presented topline performance results for the miniLab platform and results on the performance of capillary blood samples on a sampling of assays on the miniLab.
Theranos scientists conducted the tests reflected in the AACC presentation in 2016 under IRB-approved protocols, and the company intends to submit the results and conclusions to a publication for peer-review.
The technologies covered in the presentation have been not cleared or approved by the FDA and are not for sale in the U.S.
Among the highlights of the presentation:
The Theranos miniLab: The miniLab consists of a multi-channel material-handling robot that can dynamically perform tasks on samples that may traditionally require manual processing.
To work with the robot, Theranos devised a disposable cartridge that houses reagents, liquid handling tips, reaction cuvettes, and other consumables designed to facilitate a broad range of tests using different methodologies inside the miniLab.
The Theranos Virtual Analyzer (TVA) is designed to facilitate two-way communication with the miniLab, allowing for control of processes and interpretation of results, all remotely. These results could then be interpreted in a central laboratory.
The company presented 16 studies on miniLab performance data across a sampling of testing categories and methods, including chemistry, immunochemistry, hematology and molecular biology. These studies were conducted under an IRB-approved protocol.
Zika assay run on miniLab: Theranos released results on the nucleic acid detection capabilities of the miniLab, and discussed its Zika nucleic acid-amplification-based assay.
The company collected finger- stick samples from subjects, including in the Dominican Republic, and shipped those to Palo Alto to run on the miniLab.
The company has submitted assay validation data for this Zika assay to the FDA for an Emergency Use Authorization. The company is unaware of any currently available capillary test for the Zika virus.
Capillary collection methods: Holmes described the company's approach to standardizing capillary collection, including sample site preparation, finger-stick techniques, lancet selection and arterialization of capillary blood.
To facilitate collection, Theranos invented a single-use sampling device, which is a circuit consisting of two discrete capillary channels coated with anti-coagulants, and integrated, removable Nanotainer tubes that include 2D barcodes associated with patient information.
