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Summary:

Here comes a connected device that can measure fertility, testosterone, vitamin D and inflammation, while testing you for the flu. But how valuable is this data without rigorous science backing up the tests?

Cue and Cartridges Above View
photo: Cue

The quantified self movement has been mostly focused on athletes and people trying to be active and measure their progress, but in the last year or so it has branched into the medical realm. Cue is one such example of this phenomenon. The device, which debuts on Tuesday, tracks inflammation, vitamin D, fertility, influenza, and testosterone via a swab of spit, snot or blood.

The Cue is a tiny handheld device that contains a microfluidics array to test a variety of hormones found in the blood (vitamin D, fertility, inflammation), saliva (testosterone) or mucus (influenza). For $300 at retail ($150 or $200 for a set number of pre-orders), you buy the device and get a set of five cartridges that will actually handle your bodily secretions and then be disposed of. This way a family can share a Cue much like they would a scale or thermometer. Additional cartridges cost between $2 and $5 depending on the test.

Cue and Cue App

The idea here is that measuring your body chemistry might then help the average person feel better, get treatment for the flu faster or perform better at the gym. Yet, the device isn’t currently FDA approved, nor are its assessments about how other aspects of your lifestyle (you can bring in fitness and sleeping data) affect your vitamin D or fertility necessarily proven in a lab or via any public peer-reviewed science. Those who buy the device in the pre-order period 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.”

The recent recipients of the Scanadu Scout device that tracks vital signs will also have the chance to volunteer for an FDA usability study, but it’s becoming a bit worrisome to see my inbox fill with pitches for devices that can look deeper into my body chemistry and purport to show me links between my everyday activity and the lab tests my doctors assess once a year at my annual physical.

That’s not to say that there isn’t a well-researched correlation between fertility and basal body temperature and that tracking that can’t help a woman become pregnant or FDA approved blood tests for vitamin D. But there’s already a flourishing industry of supplements and over-the-counter vitamins that people spend money on even though scientific research into their efficacy is lacking. I’d hate to see the tech world launch promising products that turn out to fall at the snake oil, as opposed to science, end of the spectrum.

The combination of constant or weekly health monitoring at a relatively low cost and available data gathering that can be shared is a powerful tool for medicine that could change healthcare or diagnostics. But those benefits are lost or widely diluted if the tools to implement wide scale monitoring are deployed by people who have no understanding of the scientific method and among the limited population that has $300 to blow on a device.

Without FDA approval or peer-reviewed studies the Cue is probably more akin to a home pregnancy test, which may deliver accurate results, but your doctor will likely test you again anyhow. But a pregnancy test costs $10 to $20, not $300. A package of 20 non-digital fertility tests costs about $35.

Without rigorous testing of the device itself (are the measurements consistent and accurate?) and the assessments the app makes later (how does testosterone in a woman’s blood stream after a workout affect metabolic burn?), it’s impossible to view this device as something other than a $300 toy that might tell me to go take a walk for my daily dose of vitamin D after I prick my finger for a drop of blood.

I’m not sure we’ve gotten the balance right in medical devices between being innovative in hardware and building a product that is both genuinely insightful and also medically accurate. As these devices proliferate and the data visualization gets fancier, the medtech industry runs a risk of building products that will cause consumers to view the industry with distrust. And that would be a real step back.

This story was updated to reflect that the Vitamin D test requires a drop of blood, not saliva.

  1. thomas.krafft Tuesday, May 13, 2014

    $300 for all these tests, for an entire family or group seems like a no-brainer. Great product. I’d assume also that individual HSA or insurance providers would want to reimburse this expense – a fraction of what these tests would cost otherwise.

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    1. I agree. This review is unbalanced. The benefits were not discussed. I have read many other reviews of this product since yesterday. This is the only one that ignores and blatently discounts the upside for the consumer. Confusing.

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  2. Craig Hunter Sunday, May 18, 2014

    The testosterone portion of this device alone makes is a complete success with the athlete/fitness/bodybuilder community. That is a huge savings.

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  3. William Sacks Thursday, May 22, 2014

    I think this is an awesome product. Can’t wait to get mine.

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