people get information about their health.”
Cue has developed a small diagnostic device that enables people to measure five key health indicators. A consumer puts a blood, saliva, or mucus sample on one of five specialized cartridges and inserts it into the device, which analyzes the sample and uses a Bluetooth connection to send the findings (and related background information) to the user’s smartphone.
The technology within the 3-inch by 3-inch by 3-inch cube is an antibody-based detection system called ELISA that has been used in clinical labs for decades.
“We took a standard lab technique and compressed it, and automated it, and made it a robust platform that enables consumers to measure their own health,” Khattak said. The innovation is in the miniaturization, micro-fluidics, and in automating the assay technology in a way that eliminates the need for a laboratory technician. So anybody can do it.
The technology has not yet passed muster with the FDA. On its website, Cue says it currently has an investigational device exemption from the FDA that enables customers who pre-order the device to participate in a usability study intended to serve “as an important part of Cue’s path to FDA approval.”
Following a razors and razor blades business model, Cue plans to introduce its diagnostic cube next year with single-use cartridges that measure five conditions:
—Inflammation. By tracking C-reactive protein, a biomarker for inflammation, Cue says consumers can optimize their workouts, recovery, and heart health with data that is paired with recommendations for a healthy diet and lifestyle.
—Vitamin D. By monitoring the “sunshine vitamin,” which is actually a hormone produced by the body in response to sunlight, Cue offers smart recommendations for time in the sun to elevate mood, strengthen bones, and improve overall health.
—Fertility. Cue enables users to optimize their chances for getting pregnant by tracking Luteinizing Hormone (LH) levels. Cue also can provide alerts when LH is peaking and related information about appropriate foods to support fertility.
—Influenza. The company emphasizes Cue’s capability for early detection of flu viruses, with accompanying information that prompts users to see their doctor for appropriate treatment.
—Testosterone. By measuring testosterone, a hormone that builds muscle mass, strength, bone health, and fuels sex drive, Cue can show users how certain strength and conditioning exercises can boost natural testosterone levels and provide dietary recommendations to improve performance.
Cue obviously can expand its line of diagnostic cartridges to add new capabilities. One clue to where the company is headed is the new board member Farinas-Eisner, whose work at UCLA is dedicated to identifying biomarkers for the prevention and early detection of women’s cancers. So it seems likely Cue would have plans for a cartridge that could be used periodically to test for certain breast cancers, and perhaps other types of cancers.
The product was designed in the United States with a simplicity that hints of an Apple design aesthetic, and will be manufactured in China, Khattak said. The company plans to use its $7.5 million in Series A funding to begin production, and to help scale production by focusing on automating the manufacturing process.
Cue said in May that its product could be ordered in advance, with pre-order pricing initially set at $149 and increasing to $199 for the first 1,000 units ordered. The retail price will be $300 when the product is officially released next year, Cue says. Additional cartridges and other accessories would be sold through Cue’s online store, at www.cue.me, with shipping scheduled to begin in Spring 2015.