Consumer-related questions
What is Cue?
In a nutshell, Cue is an at-home device intended to identify diseases and track health states. Currently Cue can identify 5 molecular health markers for:
Inflammation – measures C-Reactive Protein
Vitamin D – measures 25(OH)D -- There are various forms of vitamin D including Vitamin D3(cholecalciferol) and vitamin D2 (ergocalciferol). Both forms are inactive and must be converted via various intermediate steps to the active form of vitamin D3 or calcitriol(1,25-dihydroxyvitamin D3). The last intermediate form of Vitamin D before it becomes active is calcifediol or 25-hydroxyvitamin D3[25(OH)D] – this is what Cue measures, which is the common metabolite that is used to check vitamin D status in lab tests.
Fertility – measures Luteinizing Hormone
Influenza (flu) – measures Influenza A -- There are 3 types of influenza viruses – A, B and C – with A and B being the most common types. I’m not sure why Cue is only testing for influenza A; possibly because Type A is apparently more pathogenic (causes worse flu symptoms) than Type B. It could also be a matter of cost but I’m not sure. For more info on the flu, read Flu Vaccine Q & A
Testosterone – measures Free Testosterone
How does Cue work?
There are 4 key components to Cue:
The main ‘box’ (this is what I call it since there doesn’t seem to be a specific name)
The cartridge
Cue sample wand
Your smartphone
Once you have all your components and everything’s charged, connected and ready to go, then you:
Load a cartridge into the box
Collect a droplet of saliva or blood or a nasal swab using the Cue sample wand
Slide the wand into the cartridge
Read with results on your phone within a few minutes
Cue developers are making use of the ever-expanding wireless world and transmissions to your phone are through Bluetooth 4.0.
When will Cue be available?
Cue was available for pre-order in May 2014; however, the pre-order period has closed. Currently you can be added to the wait-list for the next pre-order period but there’s no date yet when that will be.
What’s the cost?
The retail price is set at $300 although the pre-order price was $140.
Pharmacy-related questions
Is Cue not a diagnostic device?
The Cue team is very specific that the product is not a diagnostic kit – it’s an investigational device. I’m a little unclear about this fine line. If you think about a pregnancy test, a home kit has to be followed-up with a doctor’s visit before pregnancy can be confirmed – that the diagnostic step. But with Cue, there’s no follow-up test and medications can be prescribed based on the result from the device. I’m thinking that until Cue is FDA-approved it will remain under the investigational umbrella?
How will Cue affect pharmacy?
I don’t think Cue is going to negatively impact pharmacy. In fact, I think over-the-counter (OTC) sales might increase, especially for vitamin D and [symptomatic] flu medications. Prescription sales could also potentially go up.
Cue may also increase pharmacists’ interaction with patients as patients will likely have lots of questions about what to do with the results they get from their phone. Pharmacists remain the most accessible health-care providers so it will be important for us to refer when necessary and when to provide OTC choices.
One concern is that with the accessibility of WebMD and similar online sites persons are self-diagnosing more and more. How will people respond to Cue – will they remove or postpone the often important step of going to the doctor? I’m not worried about doctors who have specialties but more at the general practitioner/family medicine level. It’ll be interesting to find out.
Another concern is overwhelmed drug manufacturing. If manufacturers are alerted via Cue of outbreaks or drug shortages, this will increase production of vaccines and medications. Increased production is not uncommon but mass manufacturing is not simple, especially if multiple areas must be supplied with medications at the same time. The last thing that’s needed are recalls because batches of medications become adulterated or misbranded due to extremely high demand.
How accurate is Cue?
Since I’m only on the wait-list and haven’t tried Cue myself, I don’t know the strengths and limitations. There are also no research papers out yet. But here’s what I’ll be on the lookout for:
Efficacy: Specificity & Sensitivity
Sensitivity is the probability that a test/device (in this case Cue) will be correct in determining that a person actually has the disease being tested. Specificity is the probability that Cue will be correct if a person does notactually have the disease. Basically – how accurate is Cue?
Safety
Are cartridges to be used by more than one person in the household? Will this lead to contamination? Also, can the cartridges be cleaned and how?
Cost & Convenience
How often will Cue be updated? For e.g. the flu is caused by various types of viruses and influenza A has many different strains with more developing due to viral drifts and shifts. If you have ‘updated’ viruses and ‘non-updated’ hardware and/or software, how will Cue maintain its accuracy? If they do update, will this be free-of-charge to persons who already have a device?
Last Note
One feature I think I’ll really like about Cue’s software is that it offers dietary choices and recipes to help counteract some of the disease states – a very real-life application of Functional Foods!
Update July 2019
There's no word as yet when the wait-list period will be over. But Cue is definitely expanding. Last July, the company received $30M from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to fast-track the OTC and professional Influenza and Multiplex Respiratory Pathogen diagnostic cartridges for the Cue Health Monitoring System. Plus the company is now open for applicants. This all bodes well for consumers!