Analyst Insight: Diagnostic Imaging on an iPhone? All that Glitters is not Gold

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LONDON, UK (GlobalData), 8 October 2012 - A recent report on an iPhone app developed by the University of Utah that apparently enables Thyroid Stimulating Hormone (TSH) detection and thyroxine level management makes you wonder if it’s all too good to be true. Most people will have heard the phrase “there’s an app for that”, and while there is no limitation to the number of different apps available, the question arises if they are actually as good as they should be. If you consider the mobile health (mHealth) space, these medical imaging apps, or any diagnostic app being developed for any of the different smartphone platforms, need to be at least as good as the existing diagnostics – but are they? Or are we just getting carried away with this technological fad?

At the 82nd annual meeting of the American Thyroid Association, a team from the University of Utah led by Randy Polson presented data suggesting that by using an app and the camera of an Apple iPhone 4, combined with an additional collimating lens, optical fiber and a standard lateral flow immunochromatographic assay (LFA), TSH levels in human serum can be measured. Measuring TSH serum levels is typically the first test done to determine healthy thyroid function. Acceptable ranges for the TSH levels vary for different populations; therefore a reference range is generated by calculating a mean value after measuring the TSH levels in an adequately large population. The standard reference range is generally between 0.4–4.5mIU/L (milli-international units per liter) in adults. If TSH values are below 0.4mIU/L, that would indicate hyperthyroidism (increased activity from the thyroid gland), whereas an elevated level suggests hypothyroidism (an underactive thyroid). The test is usually demanded by a physician and carried out in a laboratory with a series of other tests, including those for hormones triiodothyronine (T3) and thyroxine (T4), to determine the activity of the thyroid gland; the TSH and other hormone levels are then quantified by immunoassay analyzers.

The list of potential issues with using an app to determine a thyroid condition (or any other disease) are endless; whether the app accommodates for batch-to-batch LFA variation, or if the app takes into account the scattering of light due to phone variation, to name just two. The enthusiasm for such apps would be very short-lived, since this market is highly competitive and dynamic. Additionally, the equipment piece that is attached to the smartphone in this particular instance is designed for an iPhone 4 and to achieve profitability, the app and accompanying hardware would need to sell in the millions and be able to accommodate different phone variations, while also maintaining the LFA cassette fitment orientation, with respect to minimizing light scatter, and reducing the need for software compensation. The camera variation from phone to phone will have to be accounted for in the software, allowing the app to make accurate measurements, unless every consumer would be willing to buy an iPhone, or the iPhone is supplied as part of a test kit.

The issue of the variations in devices/apps can be overcome by manufacturing dedicated smartphones, as Mobisante did with its ultrasound device, MobiUS SP1. However, the Mobisante device cannot be used to make calls or texts, reducing its functionality to a portable ultrasound device, similar to GE’s Vscan. The starting price of the MobiUS SP1 is $7,495. Essentially, Mobisante has modified an existing smartphone to make a dedicated reader, thus taking advantage of the economy of scale enjoyed by the phone manufacturers.

The mHealth market is expected to cross $8 billion by 2018, and although it may seem like a gold mine at this point in time, with stricter regulations coming from the US Food and Drug Administration (FDA) later this year, this market might lose its attractiveness to either the manufacturers or the consumers. If the FDA considers a mobile app to be a potential medical device, the cost of development will increase dramatically. The apps, which are typically valued at less than a dollar, will increase in price if higher development costs are passed onto the consumer. Alternatively the manufacturer may decide to bear the additional costs, whether as part of a marketing strategy or to dilute competition.

The first app to get the FDA 510(k) approval in the diagnostic imaging space (after two rejections) is the Mobile MIM app, available for anyone to download for free. This app allows physicians to access the images of patient MRI or CT scans on their phone and carry out diagnoses immediately. The company hopes to charge one dollar for every time a study is uploaded, and to use the MIM Viewer Pro it would charge $4, said Mark Cain, MIM Software’s chief technology officer. The FDA says this app should not replace workstations and must only be used in the absence of direct access to the data for diagnosis. This is possibly due to concerns over the reliability of the app when it comes to the luminance of images that might affect the diagnosis, resulting in the need for additional safety features and labeling.

There is also another aspect to consider: if commercialization of medical apps is so harmful, why is it still such an attractive market? And how are the companies involved in this industry generating a profit? The possible reasons may include generating revenues from advertisements incorporated into the app and by charging a customer for extra functionality. The companies that are most profitable are the ones that came first, and new products in a saturated market would face additional regulatory costs.

An alternative strategy would be if the manufacturer of the TSH tests co-developed an app/software to use with its unique LFA cassettes and supply the LFAs as a kit that includes the app, smartphone accessories and the smartphone itself – perhaps offering the hardware at a reduced cost compared to dedicated laboratory instrumentation. The combined package would now not be “just” a smartphone app, but would compete directly with existing laboratory instrumentation.

It is indisputable that medical apps can aid both the patient and physician, especially in the case of chronic diseases, through facilitating more effective patient management, but perhaps the medical community should wait and see how long the diagnostics app craze will last.

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