We’d like to update you on Cue, including some updates on the company, a first look at the robotic production system created to build all of the cartridges, and the latest pictures of Cue with its packaging.
When we first announced Cue to the world, we were a team of 12, today we are a team of over 50 people spanning multiple engineering disciplines including bioengineering, electrical engineering, software, virology, and automation production engineering. Our team also includes regulatory specialists and quality system experts for US and international regulatory bodies. We’ve grown to occupy two buildings here in San Diego, CA and are opening a third facility in the fall of this year.
Originally, we were planning on manufacturing both the reader/charger system (what we call Cue) and the cartridges at a contract manufacturing facility in China. However, we decided to onshore the production of Cue cartridges and produce them in a fully automated way in-house. Cue cartridges appear simple on the outside but are internally very sophisticated with many components requiring the precision assembly only robotics can provide. We also produce in-house all of the biological components such as enzymes and antibodies used in the cartridges to help generate a result from a biological sample.
Committing to assembling the cartridges in San Diego and building an automated production line for the assembly, rather than partly relying on hand assembly, was the right choice for overall quality of the product and provides a scalable manufacturing platform to meet cartridge demand after launch.
We also have been focused on developing our technology beyond what we started with for the infectious disease tests. Cue can now detect the actual DNA or RNA of an infectious agent. We developed our own nucleic acid amplification technology to help enhance sensitivity for tests such as influenza, HIV, Strep throat, Chlamydia / Gonorrhea. This was a big area of development for our engineering team and we are proud of what we accomplished.
As part of this capability, we began a partnership with Johnson & Johnson to develop a quantitative HIV viral load test especially focused on the developing world.
We are almost done with our first assembly line, as you can see in the provided pictures, and we intend to build several manufacturing lines in San Diego over the next two years. We will be adding a nearly 30,000 square foot facility built to our specification to our footprint in San Diego in the Fall of this year and phase in more lines over the next two years.
Right now, we are working on finishing and optimizing the first line which we will be building our units for clinical studies on. We are running multiple builds per day and running testing on the cartridges as we continue to verify and validate all the components and the complete system performance across the various types of cartridges.
We are excited to have entered early stage production of the Cue Health Monitoring System, including the Cue Cartridge Reader, Wireless Charging Base, and Cue Power Supply and Charging Cable, and associated packaging. We have successfully completed a pilot build of Cue units on our production line. This pilot build allowed us to run the entire product assembly process and test our fixtures and build methods.
The next build will be the Engineering Validation Testing (EVT) build which will bring our manufacturing process and our quality system and documentation together. We plan on building several hundred EVT units. Shortly after testing EVT units, we will kick off a Design Validation Testing (DVT) build. Units from DVT will be used in our upcoming clinical studies for our initial set of cartridges.
Cue’s software has evolved significantly from our first designs to become richer and easier to use. New improvements include interactive, guided tutorials to help you run tests and integrating a new API for pulling in even more sources of activity, sleep, and diet data from your connected trackers. We are implementing application-layer encryption for easy device setup and secure data transmission between Cue and your smartphone.
Thank you for being one of the first to recognize the potential of Cue and joining us on our journey. Trust that the entire team is firing on all cylinders to bring this very complex but ultimately amazing product into your hands. We are eager to bring Cue to the market by early next year.
The Cue Team