To what extent can we track our own health information at home? Cue, a device that has been developed by a San Diego company of the same name, hopes to deliver an impressive answer. Cue is designed to measure vitamin D, fertility, testosterone, inflammation (tracking C-reactive protein [CRP]), a marker of inflammation) and influenza indicators. The company this week launched a special-price offer inviting customers to pre-order Cue as of Tuesday, at the cost of $149.
The first 1,000 people to order Cue, including a set of cartridges and shipping internationally, can get the device at that price. After the first thousand, the remaining limited quantity will be priced at $199 until sold out. The retail price will be $300. The company's promotional message is that they are delivering a device for the consumer to track his or her health at the molecular level. The company makes clear that Cue is not intended to be a substitute doctor; it is an investigational device not intended for use in the diagnosis of disease or other conditions, including determination of the state of health, to cure, mitigate, treat, or prevent disease or its sequelae. Cue is aiming to travel down the path to FDA clearance, Currently, Cue is being pre-sold under an Investigational Device Exemption. The company will use information from customers of the pre-sale units for usability testing required by FDA. The company hopes to ship the pre-sold units by spring 2015.
Customers who pre-order Cue will be invited to take part in a usability study and provide feedback and data as an important part of Cue's path to FDA clearance.
"As a first customer," said the company site, "you will be invited to take part in a usability study and provide feedback and anonymized data to our company as an important part of Cue's path to FDA approval. You may opt out of this at any time."
The team said that getting FDA approval for the product was "one of our forefront priorities." They said they expect Cue to receive 510K FDA clearance within the next 12 months.
Communication between Cue and the smartphone is encrypted over a 128-bit Advanced Encryption Standard, Bluetooth 4.0 connection.
Cue is a three-inch device that weighs less than one pound. MobiHealthNews described the device as about the size of a Rubik's cube, and the cartridges, about the size of a box of matches. Cue includes a set of single use cartridges and more cartridges can be ordered from the site.
But how does it work? In brief, the device measures the stats and sends the information to an app on your smartphone, running the latest version iOS or Android, via Bluetooth 4.0. Specifically, the single-use cartridges that come with Cue are used to measure fertility, testosterone, influenza, vitamin D and inflammation. You collect, with the included sample wand, a tiny sample in the form of droplet of saliva or blood or a nasal swab. and slide it into the cartridge. After a few minutes, Cue analyzes the sample and sends it to the phone app. When the analysis is complete, Cue prompts you to remove the cartridge and dispose of it. The sample wand locks inside the cartridge and is disposed of with the cartridge.
Among members of the company's team are Ayub Khattak CEO and Clint Sever, chief product officer. The company spent four years building its technology.